Rancangan Penelitian

Rancangan harus tepat

Untuk menjamin bahwa hasil penelitian

* Valid
* Dapat di generalisasi ke pasien
lain dalam populasi

Valid: true, believable and free of bias

 Rancangan penelitian

Descriptive Analytic

Non-
Case report Experimental
experimental

Case series Clinical trial

Cohort

Case Lain-lain
control
 Rancangan penelitian

Cross sectional Longitudinal

Observational
Prospective Retrospective
(cohort) (trohoc)
uncontrolled controlled
Observational

uncontrolled controlled

Intervention
Observational (clinical trial)

uncontrolled controlled controlled uncontrolled

randomized nonrandomized
Rancangan berdasarkan waktu pengambilan
data
(1) Retrospektif
(2) Prospektif

Berdasarkan metode sampling

 Clinical Trial
 Cohort Study
 Case-Control Study
 Cross-Sectional Study
Rancangan berdasarkan cara
pengontrolan
(1) Experimen
pre-experimental design;
quasi-experimental design;
true experimental design.
(2) Observasi
Kohort
case control
Pre-Experimental Design

Ekperimental dasar
Kelompok tunggal

The One-Shot Case Study.

One Group Pretest Posttest Study.
The Static Group Comparison Study
Quasi-Experimental Design
True Experimental Design
 Evidence Base Medicine / Pharmacy

Dr. David Sackett. (Sackett D, 1996)

EBM is "the conscientious, explicit
and judicious use of current best
evidence in making decisions about
the care of the individual patient
Level of evidence
Systematic review/
Meta analysis
Randomized
Controlled Trial

Cohort studies

Case Control studies

Case Series/Case Reports

 Systematic review/
Meta analysis
A review of a clearly formulated question
that uses systematic and explicit
methods to
identify, select and critically
appraise relevant research,
and to collect and analyse data from the
studies that are included in the review.

Statistical methods (meta-analysis) may

(quantitative )or may not be used to
analyse and summarise the results of the
included studies.
Tujuan meta analisis RCT
 Meningkatkan power tujuan akhir utama;
ketika besar sampel penelitian aslinya
terlalu sedikit untuk memperlihatkan
kemaknaan
 Memperbaiki estimasi besarnya efek
 Menjawab pertanyaan yg bukan ditujukan
pd penelitian aslinya.
Example
Koch A, et al.
Low molecular weight heparin and
unfractionated heparin in
thrombosis prophylaxis after major
surgical intervention: update of
previous meta-analyses.

Br J Surg 1997;84:750-9.
A meta-analysis of 36 double-blind studies
comparing low-molecular-weight heparin
(LMWH) and unfractionated heparin (UFH) for
thromboprophylaxis after surgical intervention.
A study protocol was written, specifying the
criteria for inclusion and exclusion of clinical
trials, the search strategy for finding
publications and the main analysis, which
focused on the efficacy of LMWH in
comparison with UFH.
The result of the main analysis did not reveal a
statistically significant difference between the
two treatments.
 Case Series study

Evaluasi kumpulan data pasien yang

mendapatkan paparan/intervensi tunggal.
Sering dari satu RS atau praktek dokter.
Dapat juga kumpulan data pasien dengan satu
outcome.
Contoh :
Mengobservasi berturut-turut100 pasien
perempuan berumur< 50 tahun yang menderita
emboli paru, dan tercatat bahwa 30 diantaranya
menggunakan kontrasepsi.
Case seri bermanfaat pada CT fase
IV
- Dapat menilai kuantitas insidens
ADR
-Untuk memastikan bhw bahwa
suatu ADR tdk terjadi pd populasi
yg > besar dr populasi pd CT
sebelum obat dipasarkan.
 Case report

Laporan sederhana mengenai satu

pasien yg mendapatkan obat dan
mengalami hal khusus, biasanya
ADR.

Contoh.
Publikasi laporan kasus
seorang perempuan yg
menggunakan oral kontrasepsi dan
kemudian menderita emboli paru
Case report bermanfaat untuk
memunculkan hipotesis mengenai efek obat
untuk diuji dengan studi yang lebih dalam.

Sangat jarang dapat dilakukan laporan

kasus dapat memastikan penyebab.
Kecuali bila sangat khas dan sangat jarang
misalnya kasus ketika pasti diketahui
bahwa adenocarcinoma sel vagina seorang
pd gadis muda krn paparan dietilstilbestrol
lewat uterus.