EPIDEMIOLOGI KLINIK

Dr. Bagaswoto Poedjomartno

Sp.Rad(K)RI.,Sp.KN.,Mkes.,FICA.
Instalasi Radiologi, Unit Pelayanan
Kedokteran Nuklir, RSUP Dr. Sardjito / FK-UGM
Jogjakarta.
Untuk ATRO Citra Bangsa Nov,2011.

Dimanakah kemungkinan jawaban

terbaik untuk pertanyaanpertanyaan klinik dapat
ditemukan ?

Menerapkan prinsip dasar ilmu biologi manusia.

Menggunakan pengetahuan ilmu kimia, fisiologi
dan anatomi serta patologi untuk menyelesaikan
persoalan-persoalan klinik.
Ada garis pemisah antara ilmu dasar dengan
masalah perawatan pasien.
Melakukan penelitian-penelitian klinik yang
hasilnya relevan dengan kedokteran klinik.
Tetapi para ahli epidemiologi kurang punya riwayat
bekerja bersama-sama, sehingga arus informasi di
antara mereka juga kurang begitu baik.

EPIDEMIOLOGI KLINIK
Sebuah istilah yang tidak seorangpun diantara kita
pernah mendengarnya dalam training.
Kebutuhan semakin timbul saat kita untuk pertama
kalinya memegang tanggung jawab terhadap para
pasien.
Penanganan pasien dalam klinik kadang dilakukan
dengan cara yang amat berbeda.
Sulit memutuskan mana yang benar dan mana yang
salah dalam kedokteran klinik tersebut.
Klinisi yang sadar selalu mencari dan meningkatkan
keinginannya untuk melakukan sesuatu terhadap
pasien dengan lebih baik.

EPIDEMIOLOGI KLINIK?
Adalah merupakan sebuah basic science untuk
para klinisi
Memulainya saat perawatan penderita dimulai.
Lalu mengkajinyam, mempelajarinya dan
selanjutnya menentukan keputusan.
Epidemiologi klinik memberikan sumbangan
terhdapat tercapainya pemahaman tentang
pengamatan (observasi) yang dilakukan oleh
klinisi secara individual maupun pembuatan
laporan-laporan penelitian yang dibuat oleh
klinisi lainnya.

EPIDEMIOLOGI KLINIK
Merupakan suatu pendekatan untuk membuat
dan menginterpretasikan observasi ilmiah dalam
ilmu kedokteran.
Menggunakan prinsip-prinsip dan metodametoda epidemiologi untuk msalah-masalah
yang dihadapi dalam ilmu kedokteran klinik
Merupakan ilmu yang ada hubungannya dengan
bagaimana menduga kejadian-kejadian klinik
yang terjadi pada manusia secara utuh.
Menggunakan metoda epidemiologi untuk
melakukan analisis kejadian-kejadian klinik.

KEJADIAN-KEJADIAN MENARIK DALAM

EPIDEIOLOGI KLINIK
Masalah kesehatan yang menjadi masalah khusus bagi
pasien dan juga bagi mereka yang merawatnya.
Saat dokter berusaha untuk mengerti, menduga,
menginterpretasi dan mengubahnya sewaktu merawat
pasien.
Dipelajari langsung pada manusia / pasien itu sendiri
bukan pada binatang atau bagian dari manusia,
misalnya: biakan jaringan, hormon hipofise, membran
sel darah merah atau histopatologi sel kanker.
Mengembangkan metoda-metoda untuk mempelajari
kejadian klinik sebagai studi distribusi dan determinan
dari penyakit yang sering terjadi pada manusia.

KEJADIAN KLINIK DAN PERTANYAAN

DALAM ILMU KEDOKTERAN

Kejadia
n:
Normalitas

Pertanyaa
Apakah orang itu sehat atau sakit?
Kelainan apa yang ada hubungannya dg penyakit yg
n:
diderita?

Diagnosis
Frekuensi
Resiko
Prognosis
Perawatan
Pencegahan

Sebab

Sejauh mana ketepatan uji diagnostik atau strategi yg

digunakan unt menentukan suatu penyakit?
Seberapa sering penyakit itu terjadi?
Faktor2 apa yg ada hubungan dg meningkatnya
kecenderungan terjadinya penyakit?
Apa konsekuensi setelah timbulnya penyakit tersebut?
Bgmn perawatan bisa mengubah perkembangan
penyakit itu kelak?
Apakah pemberian perlakuan pd orang2 yg tidak sakit
bisa mencegah penyakit itu agar tidak berkembang?
Apakah deteksi dan perawatan dini bisa memperbaiki
keadaan penyakit?
Keadaan apa yg diakibatkan oleh penyakit ini?
Bgmn mekanisme patogenesis penyakit ini?

KEADAAN KESEHATAN (5D)

Death

Disease

Disability

Discomfort

Dissatisfaction

Suatu akibat dari keadaan sehat universal

yg merupakan batas waktu dari
kelangsungan kejadian itu sendiri.
Suatu kombinasi dari gejala2, tanda2 fisik
dan hasil uji laboratorium.
Suatu status fungsionalpasien dlm arti agar
mampu hidup dan melakukan kehidupan
sehari2 di rumah, di tempat kerja, atau
rekreasi tanpa tergantung kpd orang lain.
Gejala2 yang tidak enak, misalnya: nyeri,
nausea, vertigo, tinitus atau fatigue
(kelelahan).
Keadaan emosional dan mental, misalnya:
kegelisahan, kesusahan atau marah

Ada yang menganjurkan ditambah dengan D yg ke 6 yakni Destitution

yaitu kemiskinan

EPIDEMIOLOGI
Adalah disiplin riset yang membahas tentang
distribusi dan determinan penyakit dalam
populasi.
Ahli epidemiologi:
Lebih berkepentingan dengan observasi terhadap
sekelompok orang tertentu atau populasi
Tidak mengumpulkan semua data orang perorang.
Tidak mendatangi orang2 yang mereka pelajari.
Lebih menggunakan analisis kemungkinan atau
probabilitas.

PRINSIP DASAR
Tujuan dasar dari Epidemilogi Klinik
adalah menggunakan metoda
observasi klinik dan
interpretasi yang mengacu pada
suatu kesimpulan yang tepat.
Aktivitas ini didasarkan atas prinsipprinsip dasar ilmiah.

POPULASI DAN SAMPEL

Pendahuluan
Karakteristik populasi

Sensus

Demografik
Sosioekonomik
Healt status
Disease related risk
dll

Scope terlalu luas

Inefisiensi Biaya & waktu
Sistematik
Problematik
Metode koleksi data
Expresi populasi?

Pendahuluan
Mengapa diperlukan sampling?
Hemat
biaya/waktu
Akurasi
pengukuran

Kualitas pengukuran
Konsistensi
Reliabilitas

validitas

Kapan sampling diperlukan

Prevalensi/insidensi
Heterogenitas
Variasi antar populasi
Jika terlalu banyak yang dicakup:
biaya + waktu inefisien
Targeted population (specific
subject)
Eligibility criteria

Prosedur sampling
Populasi

Sampling
frame

Eligibility criteria

Sample/
subject

Syarat populasi
At risk
Relevant
Representatif
Biologically plaucible
Compliant
Follow up

Relevant
Studi tentang efek samping
kontrasepsi oral

Siapa populasi yang relevan?

Wanita?
Wanita usia subur?
Wanita pasangan usia subur?
Remaja?
Usia tertentu?

Representatif

Maternal consumption of coffee

during pregnancy and stillbirth and
infant death in first year of life:
prospective study
Singleton pregnancies
Women with valid information
about coffee consumption during
pregnancy

Biologically plaucible

Adenoidectomy versus
chemoprophylaxis and placebo for
recurrent acute otitis media in children
aged under 2 years: randomised
controlled trial
children
children aged
aged 10
10 months
months to
to 22
years
years with
with recurrent
recurrent acute
acute otitis
otitis
media.
media.
at
at least
least three
three acute
acute episodes
episodes during
during
the
the previous
previous six
six months
months

Compliant

A Randomized Trial of Aspirin to Prevent

Colorectal Adenomas in Patients with
Previous Colorectal Cancer

Age: 30-80
histologically documented colon or
rectal cancer with a low risk of
recurrentdisease

Follow up

DEXAMETHASONE
DEXAMETHASONE IN
IN ADULTS
ADULTS WITH
WITH
BACTERIAL
BACTERIAL MENINGITIS
MENINGITIS
17
17years
yearsof
ofage
ageor
orolder,
older,
had
suspected
meningitis
had suspected meningitisin
incombination
combinationwith
withcloudy
cloudy
cerebrospinal
cerebrospinalfluid,
fluid,
bacteria
bacteriain
incerebrospinal
cerebrospinalfluid
fluidon
onGrams
Gramsstaining,
staining,or
or
aacerebrospinal
cerebrospinalfluid
fluidleukocyte
leukocytecount
countof
ofmore
morethan
than1000
1000
percubic
percubicmillimeter
millimeter

Jenis-jenis sampling
Probability
sampling

Non-Probability
sampling

Systematic
sampling
Simple
random
sampling

Cluster
sampling

Quota
sampling

Snowball
sampling

Convenience
sampling

A Bad Sampling Rule:

Sample of Convenience
A sample of convenience is a sampling
rule where the researchers simply select
the cases that are easily available
This approach takes less time, money,
and effort than other techniques
The problem is that the sample is often
quite unlike the population

Another Bad Sampling Rule:

Quota Sampling
A quota sample is where the researchers modify a
sample of convenience by making sure the
sample is like the population in a small number of
specific ways
For example, they may decide to have 50%
men and 50% women
Or 50% Democrats and 50% Republicans
Other than meeting these restrictions, the sample
is still a sample of convenience
What is wrong with this approach?

RECRUITMENT

Eligibility: inclusion + exclusion

Procedure
Risk of bias
Willingness
Ethics
Written informed consent
Subjects right to withdraw

ELIGIBILITY

Inclusion

Kriteria spesifik
Disease related
Diagnosis
Fixed

Exclusion

Kontraindikasi
Riwayat
Antisipasi
Prevensi
Confounder

What is Sampling?
Sampling is the process of selecting
units (e.g., people, organizations)
from a population of interest so
that by studying the sample we
may fairly generalize our results
back to the population from which
they were chosen.
William Trochim, 2002

Sampling Key Terms

Population - complete set of individuals
having some common characteristic
e.g., Australians
Sampling frame subset of the population
from which the sample is actually drawn
e.g., White pages
Sample the set of people included in the
study (i.e., selected from the sampling
frame)
e.g., Every 1000th person in the white pages

Types of Samples
Simple Random
Systematic Random
Probability

Stratified Random
Random Cluster
Stratified Cluster
Complex Multi-stage Random
(various kinds)
Quota

NonProbability

Convenience
Purposive

Jenis-jenis sampling
Probability
sampling

Non-Probability
sampling

Systematic
sampling
Simple
random
sampling

Cluster
sampling

Quota
sampling

Snowball
sampling

Convenience
sampling

Sampling Techniques
Probability sampling

each member of
population has a specific
probability of being
chosen

Non-probability sampling

arbitrary, sample not

representative of
population

Probability Sampling Techniques

Random
Random Sampling
Sampling

everyone in population has

an equal chance of being
selected

Systematic
Systematic Sampling
Samplingevery 10th student ID number
Stratified
Stratified
Random
Random
Sampling
Sampling

population divided into

strata, then random
sampling from within each
stratum
e.g., random sampling
within each state

Cluster Sampling

identify clusters of individuals & sample from these

Multi-Stage Cluster Sampling

e.g., 1 person per selected household per selected suburb

Representativeness of Sample
Depends on
1. adequacy of sampling frame
2. selection strategy
3. adequacy of sample size
4. response rate both the % &
representativeness of people in sample who
actually complete survey
5. It is better to have a small, good sample than a
large, poor sample.

RANDOMISASI
Simple randomization
Toss
2 jenis perlakuan:
(0-4= A; 5-9=B)
3 jenis perlakuan:
(1-3= A; 4-6= B; 7-9 = C)
4 jenis perlakuan
(1-2= A; 3-4= B; 5-6= C; 7-9=D)

RANDOMISASI

Random permuted blocks

2 jenis perlakuan:
AB untuk 0-4; BA untuk 5-9
3 jenis perlakuan:
ABC= 1; ACB= 2; BAC= 3
BCA= 4; CAB= 5; CBA= 6
2 Jenis perlakuan dgn blok 4 pasien
AABB= 1; ABAB= 2; ABBA= 3
BBAA= 4; BABA= 5; BAAB= 6

RANDOMISASI

andom permuted blocks within strata

Stratifikasi
Beberapa kriteria
Contoh:
Umur < 50 tahun
Umur > 50 tahun
Umur < 50 tahun
Umur > 50 tahun

+
+
+
+

1-3 nodulus
1-3 nodulus
> 4 nodulus
> 4 nodulus

Sampling Techniques Probability

Random Sampling - everyone in

population has an equal chance of
being selected.
Systematic Sampling
e.g., every 10th student ID number
Stratified Random Sampling population divided into strata, then
random sampling from within each
stratum
e.g., random sampling within each
state

Random Sampling
Choosing a sample of size n at
random (Simple Random Sample)
from a population means
every member of the population has
the same chance of being chosen
the choices are independent of one
another

 How to select an SRS

Give each person/object a number
Record each number on a chip
Mix all in a large bowl
Draw a sample
To get n random numbers between 1 and N
(population size) you can also use

a computer
a random number table (in book p.670)

Using Roulette

Figure 1

Using Roulette
Spin the wheel. Slowly and smoothly it
comes to rest in the sector 2 (figure 1).
Spin the wheel again. It comes to rest
with (say) sector number 9. If we continue
this process, we will produce a string of
the digits 0, 1, . . ., 9 in some order.
On any one spin, the wheel has the same
chance of producing each of these ten
digits. And because the wheel has no
memory, the outcome of any one spin has
no effect on the outcome of any other. We
are producing a table of random digits.

Random Digits Table (RTB)

Line

1922
101 3

9503
4

0575
6

2871
3

9640
9

1253
1

4254
4

8285
3

7367
102 6

4715
0

9940
0

0192
7

2775
4

4264
8

8242
5

3629
0

4546
103 7

7170
9

7755
8

0009
5

3286
3

2948
5

8222
6

9005
6

5271
104 1

3888
9

9307
4

6022
7

4001
1

8584
8

4876
7

5257
3

9559
105 2

9400
7

6997
1

9148
1

6077
9

5379
1

1729
7

5933
5

6841
106 7

3501
3

1552
9

7276
5

8508
9

5706
7

5021
1

4748
7

8273
107 9

5789
0

2080
7

4751
1

8167
6

5530
0

9438
3

1489
3

6094
108 0

7202
4

1786
8

2494
3

6179
0

9065
6

8796
4

1888
3

3600
109 9

1936
5

1541
2

3963
8

8545
3

4681
6

8348
5

4197
9

Random digits properties

The digit in any position in the list

has the same chance of being any
one of 0, 1, 2, 3, 4, 5, 6, 7, 8, 9.
The digits in different positions are
independent in the sense that the
value of one has no influence on the
value of any other.

Random digits properties

Any pair of digits in the table has the same

chance of being any of the 100 possible pairs
00, 01, 02, , 98, 99.
Any triple of digits in the table has the same
chance of being any of the 1000 possible triples
000, 001, 002, . . ., 998, 999.
And so on for groups of four or more digits from
the table.

How to use the RDT

A dairy products manufacturer must select a SRS of size 5
from 100 lots of yogurt to check for bacterial
contamination. We proceed as follows:.
Label the 100 lots 00, 01, 02,, 99 in any order.
Enter RDT in any place and read systematically through
it. We choose to enter line 111 and read across:
81486 69487 60513 09297
Read groups of two digits. Each group chooses a label
attached to a lot of yogurt. Our SRS consists of the lots
having labels 81, 48, 66, 94, 87.

 If the population size is not fixed or

known, it may be harder. Sometimes
(especially in biology) its hard to
enumerate the population or to
choose at random.

SYSTEMATIC SAMPLING
1. Jane

18. Steve

35. Fred

2. Bill

19. Sam

36. Mike

3. Harriet

20. Marvin

37. Doug

4. Leni

21. Ed. T.

38. Ed M.

5. Micah

22. Jerry

39. Tom

6. Sara

23. Chitra

40. Mike G.

7. Terri

24. Clenna

41. Nathan

8. Joan

25. Misty

42. Peggy

9. Jim

26. Cindy

43. Heather

10. Terrill

27. Sy

44. Debbie

11. Susie

28. Phyllis

45. Cheryl

12. Nona

29. Jerry

46. Wes

13. Doug

30. Harry

47. Genna

14. John S.

31. Dana

48. Ellie

15. Bruce
A.

32. Bruce
M.

49. Alex

16. Larry

33. Daphne

50. John D.

17. Bob

34. Phil

1.

2.

3.

Divide the population

by the size of the
desired sample: e.g.,
50/10 = 5
Select a starting point
at random: e.g., 43 =
Heather
Select every 5th name
from the starting point

STRATIFIED SAMPLING
The goal of sampling is to select a
sample that is representative of the
population
But suppose
That people in the population differ
systematically along some
characteristic?
And this characteristic relates to the
factors being studied?

Then stratified sampling is one

solution

STRATIFIED SAMPLING

The characteristic(s) of interest are identified (e.g., gender)

The individuals in the population are listed separately
according to their classification (e.g., females and males)
The proportional representation of each class is determined
(e.g., 40% females & 60% males)
A random sample is selected that reflects the proportions in
the population, (e.g., 4 females & 6 males)

STRATIFICATION ON MORE THAN ONE FACTOR

Grade
Location

Total

Rural

1,200
[120]

1,200
[120]

600
[60]

3,000
[300]

Urban

2,800
[280]

2,800
[280]

1,400
[140]

7,000
[700]

Total

4,000
[400]

4,000
[400]

2,000
[200]

10,000
[1000]

CLUSTER SAMPLING
Instead of randomly selecting
individuals
Units (groups) of individuals are
identified
A random sample of units is then
selected
All individuals in each unit are assigned
to one of the treatment conditions

Units must be homogeneous in order

to avoid bias

Multistage Sampling
Example : government data on employment and unemployment are
gathered by the Current Population Survey, which conducts interviews
in about 60,000 households each month.

Stage 1: take a sample from 3,000 counties in

the US
Stage 2: select a sample of townships within
each of the counties chosen
Stage 3: select a sample of city blocks within
each chosen township
Stage 4: take a sample of households within
each city block
SRS at each stage

Nonprobability
Nonprobability
Sampling
Sampling Designs
Designs

Non-Probability Sampling Techniques

Quota Sampling
e.g., 50% psychology students, 30% economics
students, 20% law students
Convenience Sampling
take them where you find them method e.g.,
at shopping mall
Snowball Sampling
ask each respondent if they know someone
else suitable for survey e.g., studying drugusers

Types of Nonprobability
Samples
Convenience, Accidental, haphazard
Quota
Snowball

Modal Instance
Purposive
Expert
Heterogeneity sampling

Major Issues
Likely to misrepresent the
population
May be difficult or impossible to
detect this misrepresentation

Convenience, Accidental, or
Haphazard Sampling

man on the street

college psychology majors
available or accessible clients
volunteer samples
Problem: we have no evidence for
representativeness

Quota Sampling
select people nonrandomly according
to some quotas
Proportional Quota Sampling
Nonproportional Quota Sampling

Proportional Quota
Sampling
Objective: represent major characteristics of
population by sampling a proportional amount
of each. For example, if you know the
population has 40% women and 60% men, you
want your sample to meet that quota
Problem: how do you pick the characteristics?
How do you know their proportion in
population?

Nonproportional Quota
Sampling
making sure you have enough units from
each target group of interest (even if not
proportional)
as with stratified random sampling you
might do this to assure that you have
good representation of smaller population
groups

Snowball Sampling
one person recommends another, who
recommends another, who
recommends another, etc.
good way to identify hard-to-reach
populations
for example, homeless persons

Purposive Sampling
Might sample several pre-defined
groups (e.g., the shopping mall
survey which attempts to identify
relevant market segments)
Deliberately sampling an extreme
group
Problem: Proportionality
Problem: Need theory to correctly
sample an extreme group

SAMPLES, SAMPLE SIZE, AND SAMPLING

ERROR

Sampling error = difference

between sample and population
characteristics
Reducing sampling error is the goal
of any sampling technique
As sample size increases, sampling
error decreases

ESTIMATING SAMPLE SIZE

Generally, larger samples are needed when
Variability within each group is great
Differences between groups are smaller
Because
As a group becomes more diverse, more data
points are needed to represent the group
As the difference between groups becomes
smaller, more participants are needed to reach
critical mass to detect the difference

Sampling Techniques Non-Probability

Quota Sampling - e.g., 50% psychology
students, 30% economics students, 20%
law students
Convenience Sampling - take them where
you find them method e.g., at shopping
mall
Snowball Sampling - ask each respondent if
they know someone else suitable for survey
e.g., studying drug-users.

Representativeness of Sample
Depends on:

adequacy of sampling frame

selection strategy
adequacy of sample size
response rate both the % &
representativeness of people in
sample who actually complete survey
It is better to have a small, good
sample than a large, poor sample.

Data collection methods

Data required
Selection and definition
exposures: potential risk factors, protective
factors, confounding factors
outcomes: definition of a case, definition of a
control
example: smoking ? lung cancer
smoking: definition, quantification, categories
lung cancer: case definition, definition of a control

Items to be measured and how (scales used)

Data collection
How
?
By whom?

Tools?

Interview, observation, record review

interviewers: selection,
training
level of supervision
questionnaires, recording materials
(forms)
questionnaires: self or interviewer
administered,
face to face or telephone interview

Blind data collection?

Procedures for taking samples

4. Methods
Data handling
Data coding
during data collection, afterwards?
by whom?

Data processing

manually, by computer
software, hardware
data entry:
during the study, afterwards?
order of entry screen and structure of
data base
single entry, double entry?

4. Methods
Data analysis
Validation and data cleaning
timing: during study or later
Data analysis plan
structured in terms of the specific objectives
hypotheses tested, dummy tables
from general to specific
statistical tests used, adjustment,
standardisation

Data analysis
Dummy table:
Food specific attack rates of Salmonella infection
in a day care centre, Paris, May 1999

Why a data analysis plan ?

Prevents collection of data that will not be used
Prevents failure to collect crucial information
Better estimates of sample size for analysis of
sub groups