Teleconference 12
Program Pra Doktor
Résumé, Summary, Rangkuman
6 April 2015
Jam 11:00 -13:00
• Proses penelitian dimulai dengan suatu topik .
• Topik dapat mengenai suatu intervensi (e.g.,
Statin), suatu hasil intervensi (e.g., Pencegahan
sekunder penyakit kardiovaskuler), atau
keduanya (e.g., Farmakoterapi utk pencegahan
sekunder penyakit kardiovaskuler).
• Berdasarkan topik ini peneliti mengidentifikasi
kata-kata kunci dalam Bahasa Inggeris.
Contoh: Pharmacotherapy, Cardiovascular
Disease, Secondary Prevention.
• Dengan kata2 kunci peneliti mencari makalah
Systematic Review (SR) di mesin2 pencari.
• Cari makalah SR yg seterkini mungkin. Jika
makalah SR yg diinginkan belum ditemukan
coba terus mencari dengan menggunakan
sinonim, thesaurus (Shift F7), pengejaan yg
lain, akhiran/awalan, kata2 kunci yg terdapat
di bawah abstract makalah2 Penelitian
Empirik (PE), judul makalah2 di daftar rujukan.
Hirarki
Bukti
Sumber: http://www.mededirect.org/faculty.cfm
• Makalah SR memuat hasil critical appraisal (CA)
makalah2 PE yg dilacak dan disaring secara
sistematis.
• Biasanya yg diCA adalah makalah2 PE yg
menggunakan rancangan experimen murni
(RCT), karena validitas dalam dan luar yg tinggi
tentang efikasi intervensi.
Penafsiran Data
Pop Sasaran
Pop yg
Disampel
Inferensi statistik
Validitas Dalam
Sampel
Validitas
Luar
• Untuk menghasilkan kesimpulan yg valid ttg
efikasi intervensi, PE juga harus didasarkan
atas kerangka konsep yg valid, menggunakan
metoda pengumpulan dan pengolahan data
yg valid dan dilaksanakan dgn seksama sesuai
rencana.
• Kemungkinan kesimpulan makalah SR:
a) Tidak ada makalah PE dgn kesimpulan yg valid  PE
lebih lanjut dengan rancangan yg lebih baik.
b) Ada makalah PE dgn kesimpulan yg valid dan efikasi
intervensi bermakna secara praktis/klinis (effect size
besar)  EBP.
c) Jika effect size besar, tetapi tidak bermakna secara
statistik  replikasi dgn sample size yg lebih besar
atau meta-analysis.
d) Ada makalah PE dgn kesimpulan yg valid tetapi efikasi
intervensi tidak bermakna secara praktis/klinis 
perbaiki kerangka konsep.
• Makalah SR seterkini mungkin supaya tidak
perlu melacak terlalu jauh ke belakang
makalah2 PE yg terbit kemudian.
• Makalah2 PE yg terbit kemudian mungkin ada
yg berhasil memecahkan seluruh/sebagian
masalah penelitian Masalah Penelitian &
Tujuan Penelitian diperbaharui.
• Perhatikan metoda SR yg digunakan (utk ditiru
saat menulis Bab II) dan nilai mutunya, atau
cari makalah SR yg telah direview organisasi yg
dapat diandalkan (e.g., The Cochrane Library,
HealthEvidence).
Bab II. Telaah Pustaka
• Penelitian2 Empirik terkini (sebut metoda
telaah pustaka – narrative, scoping, + CA, SR)
• Konstruk Intervensi/Prediktor
• Konstruk Hasil Intervensi/Kriterion
• Landasan Teori, Konstruk Mediator &
Konstruk Moderator
• Kerangka Konsep
• Hipotesis2 Penelitian.
• Contoh hasil pelacakan makalah SR di Google
Scholar (sejak 2015) dgn kata2 kunci: Statin*
Systematic Review
Gudzune, K. A., Monroe, A. K., Sharma, R.,
Ranasinghe, P. D., Chelladurai, Y., & Robinson,
K. A. (2014). Effectiveness of combination
therapy with statin and another lipidmodifying agent compared with intensified
statin monotherapy: a systematic review.
Annals of internal medicine, 160(7), 468-476.
*) Mengatasi hyperlipidemia merupakan
pencegahan sekunder penyakit CV.
• Purpose: To compare the clinical benefits, adherence,
and harms of lower-intensity statin combination
therapy with those of higher-intensity statin
monotherapy among adults at high risk for
atherosclerotic cardiovascular disease (ASCVD).
• Data Sources: MEDLINE, EMBASE, and the Cochrane
Central Register of Controlled Trials from inception to
July 2013, with an updated MEDLINE search through
November 2013.
• Study Selection: Randomized, controlled trials
published in English.
• Data Extraction: Two reviewers extracted information
on study design, population characteristics,
interventions, and outcomes (deaths, ASCVD events,
low-density lipoprotein [LDL] cholesterol level,
adherence, and adverse events). Two independent
reviewers assessed risk of bias.
From: Effectiveness of Combination Therapy With Statin and Another Lipid-Modifying Agent Compared With Intensified Statin
Monotherapy: A Systematic ReviewEffectiveness of Combination Therapy With Statin
Ann Intern Med. 2014;160(7):468-476. doi:10.7326/M13-2526
Figure Legend:
Summary of evidence search and selection.
ASCVD = atherosclerotic cardiovascular disease; CENTRAL = Cochrane Central Register of Controlled Trials; FDA = U.S. Food and Drug Administration;
RCT = randomized, controlled trial; SIP = scientific information packet.
* Citations could be excluded for >1 reason; therefore, the sum of excluded studies listed from each category may exceed the actual number of
citations excluded.
Date of download: 4/5/2015
Copyright © American College of Physicians. All rights reserved.
• Data Synthesis: A total of 36 trials were included.
Low-intensity statin plus bile acid sequestrant
decreased LDL cholesterol level 0% to 14% more
than mid-intensity monotherapy among high-risk
hyperlipidemic patients. Mid-intensity statin plus
ezetimibe decreased LDL cholesterol level 5% to
15% and 3% to 21% more than high-intensity
monotherapy among patients with ASCVD and
diabetes mellitus, respectively. Evidence was
insufficient to evaluate LDL cholesterol for
fibrates, niacin, and ω-3 fatty acids. Evidence was
insufficient for long-term clinical outcomes,
adherence, and harms for all regimens.
• Limitation: Many trials had short durations
and high attrition rates, lacked blinding, and
did not assess long-term clinical benefits or
harms.
• Conclusion: Clinicians could consider using
lower-intensity statin combined with bile acid
sequestrant or ezetimibe among high-risk
patients intolerant of or unresponsive to
statins; however, this strategy should be used
with caution given the lack of evidence on
long-term clinical benefits and harms.
Bang, C. N., & Okin, P. M. (2014). Statin
treatment, new-onset diabetes, and other
adverse effects: a systematic review. Current
cardiology reports, 16(3), 1-5.
• Effek samping Statin: DM, myopathy, rhabdomyolysis, transaminase meningkat, cataract,
mood disorders, dementia, peripheral neuropathy, hemorhagic stroke.
• Finegold, J. A., Manisty, C. H., Goldacre, B.,
Barron, A. J., & Francis, D. P. (2014). What
proportion of symptomatic side effects in
patients taking statins are genuinely caused by
the drug? Systematic review of randomized
placebo-controlled trials to aid individual
patient choice. European journal of preventive
cardiology, 21(4), 464-474.
Results Among 14 primary prevention trials (46,262
participants), statin therapy increased diabetes
by absolute risk of 0.5% (95% CI 0.1–1%,
p = 0.012), meanwhile reducing death by a similar
extent: −0.5% (−0.9 to −0.2%, p = 0.003). In the 15
secondary prevention RCTs (37,618 participants),
statins decreased death by 1.4% (−2.1 to −0.7%,
p < 0.001). There were no other statinattributable symptoms, although asymptomatic
liver transaminase elevation was 0.4% more
frequent with statins across all trials. Serious
adverse events and withdrawals were similar in
both arms.
Manafsirkan ES
• Cohen’s “Rules-of-Thumb”
– standardized mean difference effect size
• small = 0.20
• medium = 0.50
• large = 0.80
– correlation coefficient
• small = 0.10
• medium = 0.25
• large = 0.40
– odds-ratio
• small = 1.50
• medium = 2.50
• large = 4.30
Sumber: http://mason.gmu.edu/~dwilsonb/downloads/interpretation.ppt
Practical Meta-Analysis -- D. B. Wilson
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Brault, M., Ray, J., Gomez, Y. H., Mantzoros, C. S., &
Daskalopoulou, S. S. (2014). Statin treatment and newonset diabetes: a review of proposed mechanisms.
Metabolism, 63(6), 735-745.
Mediator2 yg dapat diuji:
• Certain statins affect insulin secretion through direct,
indirect or combined effects on calcium channels in
pancreatic β-cells.
• Reduced translocation of glucose transporter 4 in
response to treatment results in hyperglycemia and
hyperinsulinemia.
• Statin therapy decreases other important downstream
products, such as coenzyme Q10, farnesyl
pyrophosphate, geranylgeranyl pyrophosphate, and
dolichol; their depletion leads to reduced intracellular
signaling.
Proposal = Disertasi – (Hasil, Kesimpulan & Saran)
Halaman-Halaman Muka (Halaman judul &
Pengesahan, Daftar Isi, Daftar Tabel & Daftar
Gambar, Intisari)
Bagian Utama:
• Pendahuluan
• Telaah Pustaka
• Metoda Penelitian
• Rencana Pelaksanaan  Hasil, Kesimpulan &
Saran
• Daftar Rujukan
Lampiran-Lampiran
Pendahuluan
• Latar Belakang: Masalah Praktis, Rekam Jejak
Masalah Penelitian.
• Masalah Penelitian.
• Tujuan Penelitian.
• Manfaat Penelitian,
• Keaslian Penelitian.
Telaah Pustaka
•
•
•
•
Review Makalah2 PE terkini.
Konstruk Intervensi (Prediktor).
Konstruk Hasil Intervensi (Kriterion).
Kerangka Konsep, Konstruk Mediator, dan
Konstruk Moderator
• Hipotesis Penelitian
Action
(Predictive)
Theory
Mediator
Hasil
(Kriterion)
Intervensi
(Prediktor)
F1
F2
Moderator
F3
V1
Explanatory
Theory
V2
F = Faktor = Dimensi
V = variabel atau item
Confounding = moderator
non-spesifik
24
Metoda Penelitian
A. Rancangan Penelitian:
1. Rancangan pengumpulan data.
2. Rancangan pengolahan data.
3. Rancangan penafsiran data.
B. Metoda Pengumpulan Data.
OperasionaC. Metoda Pengolahan Data.
lisasi dari A
D. Metoda Penafsiran Data.
Rencana Pelaksanaan Penelitian
• Gannt Chart (Waktu, Kegiatan)
• Anggaran.