Nama : Maydelin

NIM : 04011181722036
No Absen : 18 (GENAP)
Kelas : Alpha 2017

OSCE EVIDENCE BASED MEDICINE BLOK 24 TAHUN 2020

Patient is a 73-year-old female in good health with normal cholesterol levels and no chronic disease.
However, she comes to the clinic because she is starting to notice that she is forgetting things more
often and having problems balancing her checkbook and playing brain teaser games with her
grandchildren. Her hubsband says he hasn’t notice anything different about her. But she’s fearful that
she might be “getting Alzheimer’s Disease”. She said her neighbor told her that Lipitor is supposed to
help with the symptoms or maybe even prevent Alzheimer’s disease. She wants your advice. Would
this help? You recall a few patients complaining about memory problems while on statin but don’t
know the data on reducing the risk of AD or associated cognitive symptoms. You tell her you’ll get
back to her. You ask her about any other medications she might be on and she tells you that she is
taking Sporanox for a toe nail infection.
a) Buatlah Tabel P.I.C.O
b) Buatlah Clinical Question
c) Buatlah Search Term/Search/Keyword
d) Lakukan searching
e) Pastekan Abstract Artikel yang didapat pada lembar jawaban
f) Lakukan Crtitical Appraisal dari Artikel dengan critical appraisal worksheet
a. Tabel PICO
P = population/problem 73-year-old female in good health with normal
cholesterol levels and no chronic disease
I = intervention Lipitor (atorvastatin)
C = control/comparison Placebo or no intervention
O = outcome Reduction of Alzheimer's disease risk or improvement in
cognitive symptoms

b. Clinical Question
In a 73-year-old female with normal cholesterol levels and no chronic disease, does the use of
Lipitor (atorvastatin) compared to placebo or no intervention lead to a reduction in the risk of
Alzheimer's disease or an improvement in cognitive symptoms?

c. Search Term
Chest Pain AND Spironolactone AND Congestive heart failure AND ACE Inhibitor (Lisinopril)
AND Aspirin

d. Searching

e. Abstract
The present study enrolled 214 patients, aged 26 to 83 years, with
symptomatic New York Heart Association class II through IV congestive heart
failure. Patients were continued on their previous therapeutic regimens, which
included an angiotensin-converting enzyme (ACE) inhibitor and a loop
diuretic with or without digitalis. Patients were randomized to 1 of 5 parallel
treatment groups: placebo or spironolactone at a single daily dose of 12.5, 25,
50, or 75 mg for 12 weeks. Serum levels of creatinine, urea nitrogen,
potassium, plasma renin activity, and N-terminal proatrial natriuretic factor
(pro-ANF), as well as urinary aldosterone levels, were measured periodically.
Measurements at 12 weeks versus baseline values indicated significant
increases in plasma renin activity and aldosterone excretion and significant
decreases in systolic and diastolic blood pressure and pro-ANF. Hypokalemia
(serum potassium <3.4 mmol/L) occurred in 10% of placebo-treated patients
 and in 0.5% of the spironolactone group. The incidence of hyperkalemia
(serum potassium ≥5.5 mmol/L) was 5% for the placebo group, whereas it was
5%, 13%, 20%, and 24% for the 12.5-, 25-, 50- and 75-mg spironolactone
treatment groups, respectively. Predictors of hyperkalemia included the use of
ACE inhibitors other than captopril, ACE inhibitor dose, and baseline
elevation of serum creatinine or potassium levels. Thus, daily doses of 12.5 to
25 mg of spironolactone coadministered with conventional therapy of ACE
inhibitors, loop diuretics, and digitalis are relatively safe (provided that serum
potassium levels are monitored) and effective in blocking the effects of
aldosterone, while reducing the potential for hypokalemia in patients with
heart failure. (Am J Cardiol 1996;78:902–907)

f. Critical Appraisal
Judul artikel: Effective of SMronelacteme Added nan Angiotensifi-Converting Enzyme Inhibitor
and a Loop Diureticfor SevereChronicCongestwe Heart Failure (The Randomized Aldactone
Evaluation Study [RALES])

Penulis utama: The RALESInvestigators

Jurnal: CONGESTIVE HEART FAllURE/THE RANDOMIZED AIDACTONE EVALUATION

STUDY

SCREENING
 Does the study question match your Ya sesuai
question?

 Was the study design appropriate? Ya

VALIDITY
F: Patient Follow-Up
 Were all patients who entered the trial Ya sesuai
properly accounted for at its conclusion?
Losses to follow-up should be less than
20% and reasons for drop-out given.
 Was follow-up long enough? Ya
R: Randomization
 Were the recruited patients representative Ya,
of the target population?
 Was the allocation (assignment) of
patients to treatment randomized and Ya
concealed?
I: Intention to Treat Analysis Ya
 Were patients analyzed in the groups
to which they were randomized?

 Were all randomized patient data

analyzed? If not, was a sensitivity or Tidak, ada 2 grup yang failed to take the
“worst case scenario” analysis done? studi medication and were exluded from the
analysis because this was a study to
evaluate dose and not efficacy.
S: Similar Baseline Characteristics of Ya , sama-sama mmeilki symptomatic
Patients heart dan sama-sama menerima dosis
 Were groups similar at the start of the tetap dari ACE Inhibitor, loop
trial? diuretic, dan optional digitalis untuk
≥30 hari sebelum dosis pertama
pengobatan diberikan. Oral potasium
juga diberikan dengan dosis tetap
selama 14 hari sebelum first dose of
study medication allowed.

B: Blinding Ya, penelitian ini menggunakan double

 Were patients, health workers, and blind parallel desain.
study personnel “blind” to treatment?
If blinding was impossible, were blinded
raters and/or objective outcome measures
used?
E: Equal Treatment Ya
 Aside from the experimental
intervention, were the groups treated
equally?

Conflict of Interest Ya
 Are the sources of support and
other potential conflicts of interest
acknowledged and addressed?
Summary of Article’s Validity Ya
 Notable study strengths or weaknesses
or concerns?
 How serious are the threats to validity
and in what direction could they bias the
study outcomes?
CLINICAL IMPORTANCE

CER *Control event rate)=c/(c+d)

EER (experimenal event rate) =a/(a+b)
RR (Relative Risik)=(a+b)/(c+d)
RRR (relative Risi reduction)/RBI (relative
Benefit Increase)=(CER-EER)/CER
ARI (Atributable Riskk Reduction)/ABI
(Absolut Benefit Increase)-CER-EER
NNT (Bnmber Needed tto Treat) 1/RRR
Results OF IMPORTANCY

APPLICABILITY
`
Similar patient
1. Are your patients similar to those in the Ya
study?
2. Are they so different that the results can’t Tidak, hasilnya tidak berbeda
help you

3. How much of the study effect can you

expect for your patients

Realistic Interventions
4. Is the intervention realistic in your setting? Ya
5. Does the comparison intervention reflect Ya
your current practice?
6. What alternatives are available
Right Outcomes
7. Have all the right outcomes been Ya
considered?
8. Are the outcomes appropriate to your Ya, gejalanya sesuai dan obat yang digunakan
patient? sebelumnya juga sama, dan rentang umurnya
memenuhi
9. Does the intervention meet their values Ya
and preferences?
Overall conclusion
a. EER = 26% = 0,26
b. CER = 19% = 0,19
c. RBI = (CER-CER)/CER = (0,19-0,26)/0,19 = 0,36  36%
d. ABI = CER-EER = 0,19 – 0,26 = 0,07  7%
e. RR = EER/CER = 0,26/0,19 = 1,36  136%
f. NNT = 1/ABI = 1/0,07 = 14,2
a. Alternatif menghitung RBI = ABI/CER = 0,07/0,19 = 0,36  36%
b. Kesimpulan :
i. Terapi pada MCI menggunakan Stend yang dipasang dengan Cad
meningkatkan kesembuhan sebesar 36% dibandingkan penggunaan
ASA+atorvastatin,
ii. Selisih kesembuhan antara Stend dan ASA+atorvastatin adalah 7%
iii. RR > 1,36 mengartikan bahwa stend merupakan faktor yang
meningkatkan perbaikan pada MCI
iv. NNT 14,2 berarti dibutuhkan 14 pasien yang diobati dengan stend untuk
dapat memperoleh 1 kesembuhan/hasil yang baik
v. Stend yang dipasang dengan Cad merupakan terapi yang lebih baik
dibandingkan dengan ASA_atorvastatin pada pasien MCI /Memiliki
kemaknaan klinis
 kol3 * Penyakit Jantung Koroner (PJK) Crosstabulation
Count
Penyakit Jantung Koroner (PJK)
PJK Positif PJK Negatif Total
kol3 >148 80 153 233
<=148 5 62 67
Total 85 215 300

a. Grafik titik potong total kolesterolA dalam mendiagnosis PJK

 KolesterolA
100
Sensitivity: 94.1
Specificity: 28.8
80 Criterion: >148

Sensitivit
60

40

20
AUC = 0.543
P = 0.223
0
0 20 40 60 80 100
100-Specificity

Classification: PJK
100
90
80
70
60
50 Sensitivity
40 (%)
30
20
10
0
50 150 250 350
KolesterolA

b. Sensitifitas
Sensitivitas = 94,12

c. Spesifisitas
Spesifisitas = 28.84

d. PPV

PPV = 0,3433 34,33%

e. NPV
NPV = 0,0746  7,46%

f. Likelihood Ratio +
LR + = 1,32

g. Likelihood Ratio –
LR - = 0,20

h. LR Test
LR+/LR- = 1,32/0,20 = 6,6

i. AUC
0,543

Kesimpulan :
vi. Kolesterol A memiliki sensitivitas 94,12 dan spesifitas 28.84 dalam
mendiagnosis PJK
vii. LR + = 1,32 menunjukkan tes kolesterol tidak bermanfaat dalam mendiagnosis
PJK
viii. AUC 0,543 menunjukkan tes diagnostik kolesterol A gagal dalam mendiagnosis
PJK