Beruflich Dokumente
Kultur Dokumente
OSCE EBM
Nama : Annisa Khaira Ningrum
NIM :04011181320058
No. Soal : 38
I. An 18 year old male with no significant past medical history is brought to emergeny
department.
1.1. Tabel PICO
Abstract
PURPOSE:
To compare the safety and efficacy of corticorelin acetate (CrA) and placebo in patients with
malignant brain tumors requiring chronic administration of dexamethasone (DEX) to control
the signs and symptoms of peritumoral brain edema (PBE).
Prospective, randomized, double-blind study of 200 patients with PBE on a stable dose of
DEX. Initially, DEX dose was decreased by 50% over a 2-week period and then held at this
level for 3 weeks. The primary end point was the proportion of patients who responded to
treatment-patients who achieved a ≥ 50% DEX reduction from baseline and achieved stable
or improved neurologic examination score and Karnofsky performance score at week 2, and
then continued to respond at week 5.
RESULTS:
One hundred patients received subcutaneous injections of 1 mg twice per day of CrA and 100
patients received placebo for the duration of the study period. Although results did not attain
statistical significance (at the P < .05 level), a clinically important difference in the proportion
of responders between the CrA group (57.0%) and the placebo group (46.0%; P = .12) was
observed. In addition, the maximum percent reduction in DEX dose achieved during the
double-blind 12-week study was significantly greater in the CrA group (62.7%) than in
placebo group (51.4%; P < .001). Patients receiving CrA demonstrated an improvement in
myopathy and were less likely to develop signs of Cushing syndrome.
CONCLUSION:
CrA enables a reduction in steroid requirement for patients with PBE and is associated with a
reduction in the incidence and severity of common steroid adverse effects, including
myopathy.
TRIAL REGISTRATION:
ClinicalTrials.gov NCT00088166.
1.6. Lakukan kritikal Appraisal dari Artikel dengan critical appraisal worksheet
II. Suatu penelitian Randomized Controlled Trial yang dilakukan pada penderita Ischemic
Stroke dengan memakai regimen pengobatan baru sebagai experimental group dan
pengobatan sebagai control group.
Dead Alive
Experimental 14% (28) 86% (172)
Control 25% (50) 75% (150)
Jumlah kelompok masing-masing (n) = 200
2.1. Experimental event rate = 28/200 = 0.14
2.2.Control event rate = 50/200 = 0.25
2.3.Absolute risk reduction = EER – CER = 0.11
2.4.Relative reduction risk = ARR/CER = 0.44
2.5.Relative risk = CER/EER = 0.56
2.6.Number Needed to Treat = 1/ARR = 1/0.11=9.09
2.7.Alternative menghitung RRR = 1-RR
2.8.Kesimpulan
Dari perhitungan diatas didapatlan kelompok experimental efektif dalam mencegah
stroke sebesar 44%
NNT = adverse effect = jumlah sampel yang dibutuhkan untuk menilai efek
samping experiment
80
Sensitivity
60
40
20
0
0 20 40 60 80 100
100-Specificity
ROC curve
Variable LDL8
z statistic 0.0563
a
DeLong et al., 1988
b
Binomial exact
Youden index
Youden index J 0.1185
Sensitivity 1.18
Specificity 86.98
Sensitifitas 1.18
Spesifisitas = 86.98
PPV
NPV
LR + =
LR –
LR test
AUC
Pretest odd
Pst test od
Kesimpulan