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RANCANGAN PENELITIAN II
VALENTINA META SRIKARTIKA, S. FARM., MPH., APT
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CLINICAL STUDIES
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DESCRIPTIVE STIUDIES
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STUDY DESIGN IN CLINICAL STUDY
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DESCRIPTIVE - QUALITATIVE
n does not try to quantify anything or
use statistical methods

n it seeks to understand other

people’s perspectives and
motivations

n Typically qualitative research

focuses on words and their
meanings, and does not seek to
count things.

n Consequently, qualitative
researchers often use small sample
sizes as they are not seeking to
statistically generalise their findings.

n is often be combined with other

methods to give further insight
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DESCRIPTIVE - QUALITATIVE
Example of Researches

n A Qualitative Study Exploring Role Of Community

Pharmacy In The Irrational Use And Purchase Of
Nonprescription Antibiotics

nA qualitative study of pharmacists' perceptions of,

and recommendations for improvement of
antibiotic use

n Barriers and facilitators for medication adherence

in stroke patients: a qualitative study
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DESCRIPTIVE STUDY
CASE REPORT AND CASE SERIES

n CASE REPORT: describe the experience gained from one single

patient, participant, or client

n Example: A single case report about a nurse taking a high dose of an

oral contraceptive led to the formulation of the hypothesis that hormone
contraceptive use increases the risk of venous thromboembolism
(Jordan 1961; Vessey 1969)

n CASE SERIES: are usually based on a very small group of patients,

participants, or clients who have similar sign, symptoms, diagnoses,
histology, experiences, or behaviours

n Example: Toxic shock syndrome in 1980s. In the late 1970s, case

studies from young women with watery diarrhoea, fever, and shock
were first described in USA. The CDC obtained information from 100+
women with similar symptoms and found the relationship between
these symptoms and the use of tampons with prolonged use (CDC 1980)
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DECRIPTIVE CROSS-SECTIONAL
STUDIES
n Often called surveys or prevalence studies

n Each individual person will be examined at one point in

time

n Descriptive but could be analytical when they sought to

provide info about the presence and strength of association
 DECRIPTIVE CROSS-SECTIONAL
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STUDIES
Exampe of Researches

n Permasalahan Terkait Obat Antihipertensi pada Pasien Usia Lanjut di

Poli Geriatri RSUD Dr.Soetomo, Surabaya

n Profil Drug-related Problems Pada Pasien Geriatrik Rawat Inap Di

Bangsal Bugenvil Unit Penyakit Dalam Rsup Dr. Sardjito Yogyakarta
Periode September 2009 – Januari 2010

n Gambaran Pelaksanaan Standar Pelayanan Kefarmasian Diapotek Kota

Samarinda Tahun 2009

n Profil Konsumen Obat Tradisional Terhadap Ketanggapan Akan Adanya

Efek Samping Obat Tradisional

n Blood Glucose Target Achievement And Antidiabetes Regimen In Type-

2 Diabetic Geriatric Patients

n Pola Penggunaan Obat Dan Obat Tradisional Dalam Upaya Pengobatan

Sendiri Di Pedesaan

n Evaluasi Penggunaan Antibiotika Pada Infeksi Kaki Diabetik: Studi Kasus

Rawat Jalan Di Poliklinik Endokrinologi Rsup Dr. Sardjito Yogyakarta
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ANALYTICAL STUDIES
OBSERVATIONAL STUDIES
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ANALYTICAL STUDIES
Mengevaluasi HUBUNGAN antara Risk
Factors/Exposure dengan Outcomes
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OBSERVATIONAL CROSS-
SECTIONAL STUDIES
n Is a study that investigates the
relationship between health-
related characterictics and
other variables of interest in a
defined population at
particular time

n are used to describe disease

or drug use problems in
relation to some factor of
interest

n EXPOSURE/RISK FACTORS
& OUTCOMES all measured
at one particular point in
time
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OBSERVATIONAL CROSS-
SECTIONAL STUDIES

Outcomes
Outcomes Outcomes Outcomes
 OBSERVATIONAL CROSS-
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SECTIONAL STUDIES
Example of Researches

n Hubungan Antara Kepatuhan Penggunaan Obat Dan Keberhasilan

Terapi Pada Pasien Hipertensi Di Rumah Sakit Daerah Surakarta Tahun
2010

n Analisis Perbedaan Kualitas Pelayanan Antara Pasien Rawat Jalan Umum

Dengan Peserta Jamkesmas Di Instalasi Farmasi Rsud Ajibarang
Kabupaten Banyumas

n Pengaruh Pemberian Obat Antihipertensi Terhadap Penurunan Tekanan

Darah Pasien Stroke Iskemik Akut Yang Menjalani Rawat Inap Di Rsup
Dr. Sardjito Yogyakarta

n Analisis Efektivitas Dan Biaya Penggunaan Zink Pada Anak Dengan

Diare Akut Di Rumah Sakit Pku Muhammadiyah Yogyakarta Tahun 2011

n Faktor-faktor Yang Berhubungan Dengan Kepuasan Pasien Rawat Jalan

Dan Rawat Inap Di Puskesmas

n Beberapa Faktor Yang Berhubungan Dengan Penggunaan Obat

Tradisional Dalam Pengobatan Sendiri Di Indonesia
 OBSERVATIONAL CROSS-
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SECTIONAL STUDIES
ADVANTAGES

n Usually relatively quick and inexpensive

n Able to yield prevalence estimates

n If conducted well, results generalisable to population

n Can measure several factors & outcomes at one time

n Often good first step in investigation

n Can be first phase of a cohort study

 OBSERVATIONAL CROSS-
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SECTIONAL STUDIES
DISADVANTAGES

n cannot show cause effect relationships.

n Provides only snapshot in time of disease & can be

misleading.

n Seasonal variations of disease are not well represented in

cross-sectional studies, depending on when the study is
performed.

n They are more effective in identifying chronic diseases and

problems and less effective in identifying
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COHORT STUDY

n A Cohort or group of subjects is followed over time to study

the development of a certain disease or outcome

n All recruits are initially free of the disease or outcome of

interest

n Cohort studies also sometimes referred to as longitudinal,

prospective or follow-up studies

n Purpose: To see if people exposed to study factor are more

likely to develop outcome of interest
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COHORT STUDY-PROSPECTIVE

Outcomes No Outcomes No
Outcome Outcome
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COHORT STUDY-RETROSPECTIVE

Outcomes No Outcomes No
Outcome Outcome
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COHORT STUDY
Example of Researches

n Hubungan Antara Kepatuhan Penggunaan Obat Dan

Keberhasilan Terapi Pada Pasien Hipertensi Di Rumah Sakit
Daerah Surakarta Tahun 2010

n Pengaruh Pemberian Obat Antihipertensi Terhadap

Penurunan Tekanan Darah Pasien Stroke Iskemik Akut Yang
Menjalani Rawat Inap Di Rsup Dr. Sardjito Yogyakarta

n Blood Glucose Target Achievement And Antidiabetes

Regimen In Type-2 Diabetic Geriatric Patients
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COHORT STUDY
ADVANTAGES

n Allows for correct temporal sequence between exposure &

outcome of interest

n Incidence of outcome can be determined

n Exposure can be measured without bias related to

knowledge of outcome (has not occurred yet!)

n multiple outcomes can be measured

n Not suitable for rare outcomes

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COHORT STUDY
DISADVANTAGES

n Not always cost or time efficient (especially for outcomes

with long latency periods)

n May be difficult to accurately define & measure exposure in

historical studies

n Restricted to factors that you measure at the start (other risk

factors may become known later)

n Losses to follow-up are common & may bias results

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CASE-CONTROL STUDY

n Retrospective design

n Purpose: To see if people with outcome are more likely to

have been exposed than those without the outcome

n Subjects are selected and defined by their outcome status

that is, whether they have developed the disease or outcome
of interest

n Subjects with the outcome (cases) & those without the

outcome (controls) are then asked about exposure status
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CASE-CONTROL STUDY
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CASE-CONTROL STUDY
Example of Researches

n Adverse drug reactions and off-label and unlicensed

medicines in children

n Socio-economic status and adherence to tuberculosis

treatment: a case-control study in a district of Nepal
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CASE-CONTROL STUDY
ADVANTAGES

n Valuable to study rare outcomes or diseases with long

latency periods

n Multiple study factors / exposures can be measured

n Smaller sample size required than cohort study

n Relatively quick & inexpensive (compared to most cohort

studies)
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CASE-CONTROL STUDY
DISADVANTAGES

n May be inefficient if exposure is very rare

n Limited to one study outcome

n Does not give incidence

n Does not establish a temporal sequence of events

n Prone to measurement bias e.g. selection, recall,

misclassification bias
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EXPERIMENTAL STUDY DESIGN

n An experiment is a study designed to compare benefits of an

intervention with standard treatments, or no treatment, such
as a new drug therapy or prevention program, or to show
cause and effect.

n This type of study is performed prospectively.

n Subjects are selected from a study population, assigned to

the various study groups, and monitored over time to
determine the outcomes that occur and are produced by the
new drug therapy, treatment, or intervention.
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RANDOMISED CONTROLLED
TRIAL
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TRIAL
Example of Researches

n Analisis Efektivitas Booklet Obat Terhadap Tingkat

Kepatuhan Pasien Diabetes Melitus Tipe 2

n Pengaruh Pelayanan Informasi Obat Terhadap Potensi

Interaksi Obat Pada Pasien Rawat Inap Pada Pasien Rawat
Inap Penyakit Dalam Di Rsud Prof. Dr. Margono Soekarjo
Purwokerto Periode Maret-agustus 2010

n Kajian Efektivitas Penggunaan Pirasetam Dan Sitikolin Pada

Pasien Stroke Dengan Menggunakan The National Institute
Of Health Stroke Scale (Nihss) Di Bangsal Rawat Inap Rs Pku
Muhammadiyah Yogyakarta
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TRIAL
ADVANTAGES

n The investigators have control over variables such as the

dose or degree of intervention.

n The blinding process reduces distortion in assessment.

n Most important, this design is the only real test of cause

effect relationships.
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TRIAL
DISADVANTAGES

n Restrictive criteria for inclusion or exclusion of subjects may

produce a very homogeneous study population that restricts
application of the results to patients with other
characteristics.

n Clinical trials, especially those focused on chronic diseases,

may require years of follow-up and prolonged observation to
determine treatment outcomes.

n The result is often higher costs, increased likelihood that

patients will be lost to follow-up, and delayed treatment
recommendations.

n Ethical concerns also arise in clinical trials, and subjects .