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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

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.Question Component P-Patien or Population I-Intervention C-Comparison O-Outcome Your Question Siapakah yang diteliti? Pasien nondiabetes dengan umur >25 tahun. Obat apa yang diberikan dalam penelitian? Metformin 850 mg 2x/hari Apa pembandingnya? Perbaikan pola gaya hidup Apa saja hasil yang diharapkan? 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? .

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

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

Ada pada hal 394 . 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. .0 mmol per liter) two hours after a 75-g oral glucose load.3 to 6.9 mmol per liter) in the fasting state («125 mg per deciliter in the American Indian clinics) and 140 to 199 mg per deciliter (7. “We conducted a clinical trial involving persons at 27 centers who were at high risk for diabetes.8 to 11. 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 (22 or higher in Asians).

Ada pada hal 394 . 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.Precise details of the interventions intended f or each group and how and when they were actual ly administered . or an intensive program of lifestyle modification.

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

according to the 1997 criteria of the American Diabetes Association: a value for plasma glucose of 126 mg per deciliter (7. diagnosed on the basis of an annual oral glucose-tolerance test or a semiannual fasting plasma glucose test. training of assessors).. The secondary: In addition to the semiannual measurements. fasting plasma glucose was measured if symptoms suggestive of diabetes developed. multiple observations. Ada pada hal 394 . when applicable. “The primary outcome was diabetes.1 mmol per liter) or higher two hours after a 75-g oral glucose load. .g.0 mmol per liter) or higher in the fasting state or 200 mg per deciliter (11. any methods used to enhance the quality of measurements (e.Clearly defined primary and secondary outcome measures and.

8 to 11. or «139 mg per deciliter in the American Indian clinics.0 mmol per liter) two hours after a 75-g oral glucose load. and a plasma glucose concentration of 95 to 125 mg per deciliter (5.7 mmol per liter).6 to 7.9 mmol per liter) in the fasting state («125 mg per deciliter in the American Indian clinics) and140 to 199 mg per deciliter (7. when applicable. Recruitment was designed to enroll approximately half the participants from racial or ethnic minority groups.How sample size was determined and. Ada pada hal 394 .” . Before June 1997. 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 the trial. A four-step screening and recruitment process was developed to identify eligible participants. 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). These concentrations are elevated but are not diagnostic of diabetes according to the 1997 criteria of the American Diabetes Association. the criterion for plasma glucose in the fasting state was 100 to 139 mg per deciliter (5.3 to 6. ” Eligibility criteria included an age of at least 25 years. explanation of any interim analyses and stopping rules.

including details of any restriction (eg: blocking. . stratification) Tidak dijelaskan didalam jurnal.Method used to generate the random allocation sequence.

Tidak dijelaskan didalam jurnal. numbered containers or central telephone). . clarifying whether the sequence was concealed until interventions were assigned..Method used to implement the random allo cation sequence (e.g.

” . randomized clinical trial involving adults in the United States who were at high risk for the development of type 2 diabetes.Who generated the allocation sequence. who enrolled participants. “The Diabetes Prevention Program Research Group conducted a large. Ada pada hal 393 . and who assigned par ticipants to their groups .

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

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

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


The participants were followed for an average of 2. From 1996 to 1999.8 years” . Ada pada hal 395 . and 1079 to the intensive lifestyle intervention). we randomly assigned 3234 study participants to one of the three interventions (1082 to placebo. 1073 to metformin.Dates defining the periods of recruitment and follow up.

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


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

5) for the lifestyle intervention and 13. 8. respectively.” .7 to 33.9 (95 percent confidence interval.9) for metformin. 5.9 percent. and lifestyle-intervention groups. 95% convident interval). 21. Ada pada hal 397 . metformin.4 percent in the placebo. "The estimated cumulative incidence of diabetes at three years was 28.For each primary and secondary outcome. 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. and 14.7 percent. and the estimated effect and it’s precision (eg.4 to 9. a summary of result for aech group.9 (95 percent confidence interval. On the basis of these rates.

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

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

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. Ada pada hal 398 . and outcomes. taking into account study hypotheses.” . sources of potential bias or imprecision.

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

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

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

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