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RINA P 08711101
PUTRI R 10711035
IMAM H 10711202
INDRA S 10711227

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 232 mg/dL. Dokter
memberikan obat berupa Adalat (nifedipi, obat
antihipertensi), glibenklamid, metformin, dan

Question Component
P-Patien or Population


Your Question
Pasien nondiabetes
dengan umur >25 tahun,
IMT 24 atau lebih (22
untuk asia), KGD 95-125
mg/dl dan 140-199 mg/dl
setelah 2 jam menerima
75 g glukosa oral.
Metformin 850 mg 2x/hari
Perbaikan pola gaya hidup
Perbaikan gaya hidup dan
metformin menurunkan
kejadian diabetes pada
orang dengan risiko tinggi

The well-built clinical question : Terapi mana yang lebih baik antara perubahan gaya hidup dan metformin untuk menurunkan angka kejadian DM type 2 pada orang dengan risiko tinggi? .

g. "randomized". "random allocation". Ada pada hal 393 . or "randomly assigned"). metformin (850)” ..How participants were allocated to inte rventions (e. “Methods We randomly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo.

formerly called non-insulin-dependent diabetes mellitus. is a serious. costly disease affecting approximately 8 percent of adults in the United States.Scientific background and explanation o f rationale. Ada pada hal 393 . “Diabetes mellitus.” .

. Eligibility criteria included an age of at least 25 years.9 mmol per liter) in the fasting state («125 mg per deciliter in the American Indian clinics). “We conducted a clinical trial involving persons at 27 centers who were at high risk for diabetes..3 to 6. a bodymass index (the weight in kilograms divided by the square of the height in meters) of 24 or higher (22 or higher in Asians). and a plasma glucose concentration of 95 to 125 mg per deciliter (5..Eligibility criteria for participants and the settings and locations where the data were collected .” . Ada pada hal 394 .

” . or an intensive program of lifestyle modification.Precise details of the interventions inten ded for each group and how and when they w ere actually administered. standard lifestyle recommendations plus placebo twice daily. “Participants were randomly assigned to one of three interventions: standard lifestyle recommendations plus metformin (Glucophage) at a dose of 850 mg twice daily. Ada pada hal 394 .

Specific objectives and hypotheses.” . “We hypothesized that modifying these factors with a lifestyleintervention program or the administration of metformin would prevent or delay the development of diabetes. Ada pada hal 393 .

any methods used to enhance the quality of measurements.. when applicable. “The primary outcome was diabetes.. fasting plasma glucose was measured if symptoms suggestive of diabetes developed. Ada pada hal 394 . according to the 1997 criteria of the American Diabetes Association.” ..” “The secondary: In addition to the semiannual measurements..Clearly defined primary and secondary outcome measures and.. diagnosed on the basis of an annual oral glucose-tolerance test or a semiannual fasting plasma glucose test.

” Eligibility criteria included an age of at least 25 years. a bodymass Index (the weight in kilograms divided by the square of the height in meters) of 24 or higher . explanation of any interim analyses an d stopping rules Ada pada hal 394 .. when applicable. Eligible persons were excluded if they were taking medicines known to alter glucose tolerance or if they had illnesses that could seriously reduce their life expectancy or their ability to participate in .How sample size was determined and. ..

including details of any restriction Tidak dijelaskan didalam jurnal. .Method used to generate the random allocation sequence.

clarifying whether the sequence was concealed until interventions were assigned Tidak dijelaskan didalam jurnal. .Method used to implement the rand om allocation sequence.

randomized clinical trial involving adults in the United States who were at high risk for the development of type 2 diabetes. A “The Diabetes Prevention Program Research Group conducted a large. da pada hal 393 .” . and who assigned partici pants to their groups . who enrolled particip ants.Who generated the allocation s equence.

Ada pada hal 394 . such as subgroup analyses and adjusted analyses. Methods for additional analyses.Statistical methods used to compare g roups for primary outcome(s) . .

Specifically. Discribe protocol deviations from study planned. for each group report the number of participant randomly assigned.Flow of participant through each stage (a diagram is strongly recommended). . completing the study protocol. and analyzed for the primary outcome. receiving intended treatment. together with reasons. Ada pada hal 395 .

the closing date for this report. If done. on the basis of data obtained through March 31. and those assessing the outcomes were blinded to group assignmen t. blinding was evaluated. 2001.Whether or not participants.” “The blinded treatment phase was terminated one year early. how the success Ada pada hal 394of. Assignments to metformin and placebo were double-blinded. those administe ring the interventions. in May 2001. on the advice of the data monitoring board.” .


and 1079 to the intensive lifestyle intervention). From 1996 to 1999.Dates defining the periods of recruitment and follow up. we randomly assigned 3234 study participants to one of the three interventions (1082 to placebo.8 years” . The participants were followed for an average of 2. 1073 to metformin. Ada pada hal 395 .

including all measured risk factors for diabetes. Ada pada hal 395 .Baseline demographic and clinical characteristics of ech group. “Base-line characteristics.” . were similar among the three study groups (Table 1).


10/20.” . 1073 to metformin.Number of participant (denominator) in eah group included in each analysis and whether the analysis was by “intention – to – treat. and 1079 to the intensive lifestyle intervention). not 50%) Ada pada hal 395 .” State the result in absolut number as when feasible (eg. we randomly assigned 3234 study participants to one of the three interventions (1082 to placebo. “From 1996 to 1999.

On the basis of these rates. metformin. Ada pada hal 397 .4 to 9.5) for the lifestyle intervention and 13.7 to 33. a summary of result for aech group. the estimated number of persons who would need to be treated for three years to prevent one case of diabetes during this period is 6. "The estimated cumulative incidence of diabetes at three years was 28.7 percent. 5. and the estimated effect and it’s precision (eg. 21. and 14.9) for metformin.For each primary and secondary outcome.4 percent in the placebo. 95% convident interval).” .9 (95 percent confidence interval.9 (95 percent confidence interval.9 percent. and lifestyle-intervention groups. 8. respectively.

including sub group analyses and adjusted analyses. indicating those prespecipied and those exploratory.Adress multiplicity by reporting any other analyses peformed. Di dalam jurnal tidak dijelaskan .

All important adverse events or side effects in each intervention group. Ada pada hal 397 & 401 . .

taking into account study hypotheses. sources of potential bias or imprecision. Ada pada hal 398 .” . and outcomes.Interpretations of the result. ” Our results support the hypothesis that type 2 dibetes can be prevented or delayed in persons at high risk for the disease.

metformin was effective in our study. perhaps because of small samples and the lack of data on adherence to the prescribed regimens. In contrast.” . althoughless so than the lifestyle intervention. “Previous studies have not demonstrated that drugs used to treat diabetes are effective for its prevention. Ada pada hal 399 .Generalizability (external validity) of the trial findings.

General interpretation of the result in the context of current evidence. it should also be possible to delay or prevent the development of complications. The lifestyle interventions was particularly effective. Ada pada hal 401 . substantially reducing the individual and public health burden of diabetes.” . our study showed that treatment with metformin and modification of lifestyle were two highly effective means of delaying or preventing type 2 diabetes. with one case of diabetes prevented per seven persons treated for three years. Thus. “In summary.

Were subjects and clinicians blind ‘ to which treatment was being received? 1c. dan gaya hidup 1079 2b. Pengacakan tidak dilakukan secara sembunyi 1c. Antara subjek dan peneliti dibutakan 2a. Diambil dari 27 pusat klinik secara acak sebanyak 3234 orang dengan kriteria yang memenuhi. Were all subjects who entered the trial accounted for at its conclution? 2a. Sesuai dengan tabel 1 . Pasien diambil secara acak dari randomised? 27 pusat klinik dengan mengambil 3234 pasien nondiabetik namun risiko tinggi DM 1b. Was the randomisation list concealed? 1b. metformin 1073. Was the assignment of patients 1a.THERAPY WORKSHEET Is the research valid? Comments 1a. Were they analysed in the groups to which they were randomised? 2b. Semua partisipan diperhitungkan dalam hasil yaitu berjumlah 3234 orang dengan rincian plasebo 1082.

were the groups treated aqually? 3b.. Were the groups similar at the start of the trial? 3a. Dari awal sampai akhir penelitian berjumlah 3234 orang dan sebanyak 99. Aside from the experimental treatment. 3a.Cont... Di dalam disebutkan jurnal tidak 3b.6% masih hidup. .