BIAS DALAM PENELITIAN

DR DRG HELWIAH UMNIYATI MPH

Error
Suatu fenomena dimana hasil dari suatu studi epidemiologi
tidak menggambarkan kenyataan (atau kebenaran).


1.Hasil yang baik Nilai yang diamati = Kenyataan

2.Hasil yang error Nilai yang diamati = Kenyataan +
Penyimpangan

Estimated effect: the truth?
Mayonnaise Salmonella
RR = 4.3
Bias?
Chance?
Confounding?

True association?
Errors in epidemiological
studies
Tipe tipe dasar Error
1. Random (chance) Error
2. Systematic Error/Sistematik error
2.1. Bias
2.2. Confounding
1. Error yang menyebabkan nilai-nilai yang diamati berbeda dari nilai
yang sebenarnya.
2. Terjadi akibat variabilitas sample atau fluktuasi random dari kejadian
yang diharapkan.
3. Error jenis ini dapat muncul pada setiap saat kita melakukan random
sample dan membuat kesimpulan dari masing-masing populasi.
4. Hal ini tidak dapat dihindari, tidak dapat dikontrol dan dapat terjadi
pada masing-masing arah/direksi.
5. Besarnya error dapat dibatasi dengan
5.1. Jumlah sample yang adekuat
5.2. Pengambilan sample yang tepat(Probability Sampling)

Random Error
Random ERROR
1. Dapat terjadi setiap saat dalam penelitian

2. Dapat diatasi dengan :

2.1.Penghitungangan sampel minimal yang tepat
dengan menggunakan perhitungan Probability Sample
Size

2.2.Probability Random Sampling yang tepat =
Pengambilan Sampel dari populasi memakai metoda
Probability Random Sampling


Definition of bias
Any systematic error in the design or
conduct of an epidemiological study
resulting in a conclusion which is
different from the truth

Bias
Yaitu bergerak menjauhi kebenaran atau harapan
Penting diperhatikan dalam penelitian karena potensi
efek pada makna dari hasil penelitian
Faktor yang berkaitan dengan bias:
Peneliti
Alat pengumpul data
Subyek penelitian
Sampel
Data
Uji statistik
Main sources of bias
1. Selection bias
2. Information bias
Sumber-sumber bias
1. Proses seleksi atau partisipasi subyek
( bias seleksi)
2. Proses pengumpulan data ( bias
informasi)
3. Tercampurnya efek pajanan utama
dengan efek faktor risiko eksternal
lainnya ( kerancuan/ confounding)
Selection bias
Two main reasons:
Selection of study subjects
Factors affecting study participation

association between exposure and disease
differs between those who participate and
those who dont
3 karakteristik penting bias seleksi
1. Terjadi ketika menggunakan kriteria yang
berbeda dalam prosedur seleksi subyek
2. Besar dan arahnya seringkali tidak dapat
diperkirakan
3. Bias ini, sekali terjadi tidak dapat
dikendalikan, melainkan hanya dapat
dicegah.
Types of selection bias
Sampling bias
Ascertainment bias
referral, admission
Diagnostic/surveillance
Participation bias
self-selection (volunteerism)
non-response, refusal
survival
Selection bias in case-control
studies
Selection of controls
How representative are hospitalised trauma patients
of the population which gave rise to the cases?

Cases
liver cirrhosis
Controls A
trauma ward
Heavy alcohol use
80 40
Light/no alcohol use
20 60

OR = 6
Estimate association of alcohol intake and cirrhosis
Selection of controls

Cases
liver cirrhosis
Controls A
trauma ward
Controls B
non-trauma
Heavy alcohol use 80 40 10
Light/no alcohol use 20 60 90

OR = 6 OR = 36
Higher proportion of controls drinking alcohol in trauma
ward than non-trauma ward
a b
c d
Some worked examples
Work in pairs
In 2 minutes:
Identify the reason for bias
How will it effect your study estimate?
Discuss strategies to minimise the bias
Oral contraceptive and uterine cancer
OC use breakthrough bleeding increased
chance of testing & detecting uterine cancer

Cases
uterine cancer
Controls
Takes oral
contraceptives
a b
Does not take oral
contraceptives
c d

You are aware OC use can cause breakthrough bleeding

Overestimation of a overestimation of OR
Diagnostic bias
a b
c d
Lung cancer cases exposed to asbestos not representative
of lung cancer cases
Asbestos and lung cancer

Cases admitted
and diagnosed
with lung cancer
Controls from
surgical wards
Contact with
asbestos
a b
No contact with
asbestos
c d

Overestimation of a overestimation of OR
Admission bias
a b
c d
Prof. Pulmo, head specialist respiratory referral unit, has 145
publications on asbestos/lung cancer
Selection bias in cohort studies
Prospective cohort study- Year 1
Smoker 90 910 1000


Non-smoker 10 990 1000
lung cancer
yes no
9
1000
10

1000
90
RR
Loss to follow up Year 2
Smoker 45 910 955


Non-smoker 10 990 1000
lung cancer
yes no
4.7
1000
10

955
45
RR
50% of cases that smoked
lost to follow up
Minimising selection bias
Clear definition of study population
Explicit case, control and exposure definitions
CC: Cases and controls from same population
Same possibility of exposure
Cohort: selection of exposed and non-exposed without
knowing disease status
Sources of bias
1. Selection bias
2. Information bias


Information bias
During data collection
Differences in measurement
of exposure data between cases and controls
of outcome data between exposed and
unexposed
Information bias
3 main types:
Recall bias
Interviewer bias
Misclassification

Bias informasi merupakan error/kesalahan
dalam mendapatkan data dari masing-
masing subjek
Kesalahan pengukuran,
Recall bias,
Interviewer bias dll.

Bias Informasi
1. Subjek dengan penyakit yang dibuat-buat mungkin lebih intensif
untuk mengingat paparan yang diduga sebagai faktor
dibandingkan orang yang sehat.
2. Hal ini sangat penting pada kasus-kasus malformasi kongenital.
Ibu dari bayi yang malformasi, ternyata lebih keras untuk
mengingat kembali abnormalitas atau beberapa macam obat yang
ia gunakan selama hamil dibanding ibu-ibu dengan bayi yang
normal.
3. Recall bias timbul dari fakta bahwa, meskipun angka paparan
pada 2 kelompok secara aktual sama, penyelidikan yang intensif
diantara kasus-kasus akan menghasilkan proporsi paparan yang
tinggi, yang menghasilkan odd ratio yang tinggi

Recall Bias
Mothers of children with malformations remember
past exposures better than mothers with healthy
children
Recall bias
Mothers of
Children with
malformation
Controls
Took tobacco,
alcohol, drugs
a b
Did not take c d
Cases remember exposure differently than controls
e.g. risk of malformation
Overestimation of a overestimation of OR
Investigator may probe listeriosis cases about
consumption of soft cheese (knows hypothesis)
Interviewer bias
Investigator asks cases and controls differently about exposure
e.g: soft cheese and listeriosis
Cases of
listeriosis
Controls
Eats soft cheese a b
Does not eat
soft cheese
c d
Overestimation of a overestimation of OR
Misclassification
Measurement error leads to assigning
wrong exposure or outcome category
Exposure Outcome
Misclassification
Systematic error
Missclassification of exposure DIFFERS
between cases and controls
Missclassification of outcome DIFFERS
between exposed & nonexposed
=> Measure of association distorted
in any direction

Misclassification
250
100
150
100 50 50 Nonexposed
150 50 100 Exposed
Total Controls Cases
OR = ad/bc = 2.0; RR = a/(a+b)/c/(c+d) = 1.3
True Classification
250 100 150
110 60 50 Nonexposed
140 40 100 Exposed
Total Controls Cases
Differential misclassification
OR = ad/bc = 3.0; RR = a/(a+b)/c/(c+d) = 1.6
Misclassification
250 100 150
100 50 50 Nonexposed
150 50 100 Exposed
Total Controls Cases
OR = ad/bc = 2.0; RR = a/(a+b)/c/(c+d) = 1.3
True Classification
250 100 150
110 50 60 Nonexposed
140 50 90 Exposed
Total Controls Cases
Differential misclassification
OR = ad/bc = 1.5; RR = a/(a+b)/c/(c+d) = 1.2
Minimising information bias
Standardise measurement instruments
questionnaires + train staff
Administer instruments equally to
cases and controls
exposed / unexposed
Use multiple sources of information
Summary: Controls for Bias
Choose study design to minimize the
chance for bias
Clear case and exposure definitions
Define clear categories within groups (eg
age groups)
Set up strict guidelines for data
collection
Train interviewers
Summary: Controls for Bias
Direct measurement
registries
case records
Optimise questionnaire
Minimize loss to follow-up
The epidemiologists role
1. Reduce error in your study design
2. Interpret studies with open eyes:
Be aware of sources of study error
Question whether they have been
addressed
Confounding merupakan penyimpangan pengaruh
faktor resiko dimana terjadi tumpang tindih
pengaruh dari faktor resiko yang diteliti dengan
pengaruh dari faktor-faktor resiko yang lain.
Rothman menyebutnya: confusion of effects

Confounding














(E) Pajanan/ faktor
risiko utama

(D) Penyakit yang
ingin diteliti
(C) Faktor eksternal/
confounder potensial

Confounding

Faktor-faktor luar yang bertanggung jawab
dengan terjadinya confounding kemudian
disebut confounder atau confounding
variable.
Bias confounding ini sendiri juga dikenal
mempunyai banyak nama lain, seperti
susceptibility bias, specification bias,
Simpsons paradox, spurious association,
secondary association.


Confounding

Perbedaan lain dengan bias seleksi dan
bias informasi adalah bahwa jika
confounders dapat diidentifikasi dan diukur
secara adekuat pada seluruh subyek
penelitian, kita dapat mengendalikan- (to
control) atau menyesuaikan (to adjust)
efek yang terdistorsi pada tahap analisis
data, sementara pada golongan bias
seleksi dan informasi pengendalian
semacam ini pada tahap analisis tidak
dimungkinkan
Warning!
Chance and confounding can be
evaluated quantitatively
Bias is much more difficult to evaluate
Minimise by design and conduct of study
Increased sample size will not eliminate
bias