STROBE

STrengthening the Reporting of

OBservational studies in
Epidemiology
Nur Aisyah Jamil
OUTLINE
• Desain Observasional
• STROBE
• Aplikasi STROBE pd jurnal
 1x (Cross sectional)

No of
2x (Before-After Study ))
Contact

>3x (Longitudinal study)

Retrospective

Desain Reference
Period Prospective
Penelitian

Retrospective-prospective

Eksperimental

Quasi
Nature Eksperimental
Investigation
Non Case-
Eksperimen Control
Sumber : Kumar R,1999 tal(Observa
sional )) Cohort
 Epidemiologist

Desain
Penelitian

Deskriptif Analitik

Distribusi Frekuensi Eksperimental Observasional

Laborat
RCT Case-
Orang Tempat Insidensi orium Cohort
Prevalensi control
Waktu
dll
 STROBE
• Inadequate report
• Metodologist, researcher,journal editor
• 22 items
• Item 6,12,14,15specific desain
 1. Title and abstract
• (a) Indicate the study’s design with a
commonly used term in the title or the
abstract

Judul menunjukkan desain penelitian yg dipakai dan

cukup infromatif menginformasikan variable yang
diteliti/menjadi focus utama
 1. (Cont)Abstract
• (b) Provide in the abstract an informative and
balanced summary of what was done and what was
found

Komponen Abstrak : latar

belakang,/rasionalisasi, tujuan, metodologi
(desain case-control/matching, sampling
(populasi,besar sampling/power), variable,
analisis, hasil utama, kesimpulan dan
implikasi studi/saran
 Introduction
2. Background/rationale
• Explain the scientific background and rationale
for the investigation being reported

Latar belakang menjelaskan mengapa perlu diteliti,

1. masalah kesehatan,
2. apa yang sudah diketahui dari evidence/penelitian
sebelumnya dan
3. apa yang belum (gap/state of the art/novelty)
 3. Objectives
• State specific objectives, including any
 paragraph
prespecified hypotheses
terakhir dalam introduction

Cukup jelas
 Methods
4. Study design
• Present key elements of study design early in
the paper

Cukup jelascase control

 5. Setting
• Describe the setting, locations, and relevant
dates, including periods of recruitment,
exposure, follow-up, and data collection

Tempat=RS (kasus dan control), waktu

(januari 2006 sd feb 2016),paparan
blm dijelaskan, follow up dan data
collection sekilas.
 6. Participants
• (a) Give the eligibility criteria, and the sources and methods of case
ascertainment and control selection. Give the rationale for the choice of
cases and controls.
• (b). For Matched study, give the matching criteria and the number of
controls per case

Cukup jelas
 Tambahan….
• Cohort study—Give the eligibility criteria, and
the sources and methods of selection of
participants. Describe methods of follow-up
• Cohort study—For matched studies, give
matching criteria and number of exposed and
unexposed
• Cross-sectional study—Give the eligibility
criteria, and the sources and methods of
selection of participants
 7. Variables
• Clearly define all outcomes, exposures,
predictors, potential confounders, and effect
modifiers. Give diagnostic criteria, if applicable

Dijelaskan dalam Data Collectionand exposure definition

Kerangka Konsep
 Syarat
Confounding

• It is a risk factor for the disease, independent of the putative risk factor.
• It is associated with putative risk factor.
• It is not in the causal pathway between exposure and disease.
• The first two of these conditions can be tested with data. The third is
more biological and conceptual.
• Effect modification is all about stratification and occurs when an
exposure has a different effect among different subgroups. Effect
modification is associated with the outcome but not the exposure.
• For example, imagine you are testing out a new treatment that has come
onto the market, Drug X. If Drug X works in females but does not work in
males, this is an example of effect modification.
Cukup jelas
 8*. Data sources/ measurement
• For each variable of interest, give sources of
data and details of methods of assessment
(measurement). Describe comparability of
assessment methods if there is more than one
group
• *Give information separately for cases and
controls in case-control studies and, if
applicable, for exposed and unexposed groups
in cohort and cross-sectional studies
Dijelaskan dalam Data Collectionand exposure definition
 9. Bias
• Describe any efforts to address potential
sources of bias
Discussionbag Limitation
 BIAS

Selection Bias Information/ Confounding

Missclassified Bias
Self Diagnostic Loss to Bias
/ Workup follow up / Prevalence
selection -incidence
bias bias withdrawal Recall Reporting bias /
bias bias
bias Hawthorne effect
Publicity
bias Healthy
worker
bias

Most simplistically, there are three types of bias: (1) selection bias, (2) information /
misclassification bias, (3) confounding bias. This basic classification derived from the studies
by Miettinen in the 1970s (see for example Miettinen & Cook, 1981)
  Kasus Kontrol
Risk
No Risk c
a b
d
10. Study Size
• Explain how the study size was arrived at

2
[ z  2 p 2 (1  p 2 )  z  p1 (1  p1 )  p 2 (1  p 2 ) ]  

n1  n 2  2

( p1  p 2 ) 2
 COHORT/CROSS SECTIONAL

2
[ z 2 p(1  p)  z p1 (1  p1 )  p2 (1  p2 ) ]
n1  n2  2
( p1  p2 ) 2

Outcome
Ṗ merupakan rata-rata P1 dan P2
P1=insidensi pada kelompok terpapar (a/(a+b)   Yes No
P2=insidensi pada kelompok tidak terpapar (c/c+d) Yes a b
Paparan
P1=RRxP2
No c d
 11. Quantitative variables
• Explain how quantitative variables were
handled in the analyses. If applicable, describe
which groupings were chosen and why

Numerikkategorikrasionalisasi?

Cukup jelas  data collection and definition

 12. Statistical methods
• (a) Describe all statistical methods, including those used to control for
confounding
• (b) Describe any methods used to examine subgroups and interactions
• (c) Explain how missing data were addressed
• (d) Cohort study—If applicable, explain how loss to follow-up was addressed, Case-
control study—If applicable, explain how matching of cases and controls was
addressed. Cross-sectional study—If applicable, describe analytical methods taking
account of sampling strategy
• (e) Describe any sensitivity analyses
a. ok, Chi square/Fisher Exact, Student t test;confoundinglog regression
b.Fig 1 dan table 3
c. Missing data table 2
d. matching

e. Sensitivity analisisvariasi kelompok kontrol

 Results
13*. Participants
• (a) Report numbers of individuals at each
stage of study—eg numbers potentially
eligible, examined for eligibility, confirmed
eligible, included in the study, completing
follow-up, and analysed
• (b) Give reasons for non-participation at each
stage
• (c) Consider use of a flow diagram
FLOW DIAGRAM
 14*. Descriptive data
• (a) Give characteristics of study participants (eg
demographic, clinical, social) and information on
exposures and potential confounders
• (b) Indicate number of participants with missing data
for each variable of interest
• (c) Cohort study—Summarise follow-up time
(eg, average and total amount)
 15*. Outcome data
• Cohort study—Report numbers of outcome
events or summary measures over time
• Case-control study—Report numbers in each
exposure category, or summary measures of
exposure
• Cross-sectional study—Report numbers of
outcome events or summary measures
 16. Main results
• (a) Give unadjusted estimates and, if applicable, confounder-
adjusted estimates and their precision (eg, 95% confidence
interval). Make clear which confounders were adjusted for
and why they were included
• (b) Report category boundaries when continuous variables
were categorized
• (c) If relevant, consider translating estimates of relative risk
into absolute risk for a meaningful time period
 17. Other analyses
• Report other analyses done—eg analyses of
subgroups and interactions, and sensitivity
analyses
Subgroup analysis
Analysis interaction
 Sensitivity Analysis

Greenland S,1996 :
Sensitivity Analysisanalisis untuk memeriksa sensitivitas hasil
penelitian akibat potensial bias
Potensial bias : unmeasured confounders, classification error dan
bias seleksi
 Discussion
18. Key results
• Summarise key results with reference to study
objectives
 Hubungan sebab akibat
• Hubungan waktu(temporal relationship)
• Kuatnya assosiasi (p,CI,OR,RR)
• Dose dependent/biologically gradient
• Konsistensi, pada kelompok usia,jenis kelamin, ras
lain
• Koherensisampel ke populasi
• Biological plausibility
• Kesamaan dengan penelitian lain dengan design
beda, populasi beda,dsb
 19. Limitations
• Discuss limitations of the study, taking into
account sources of potential bias or
imprecision. Discuss both direction and
magnitude of any potential bias

Idem saat penjelasan bias

 20. Interpretation
• Give a cautious overall interpretation of
results considering objectives, limitations,
multiplicity of analyses, results from similar
studies, and other relevant evidence
 21. Generalisability
• Discuss the generalisability (external validity)
of the study results
 Other information
22. Funding
• Give the source of funding and the role of the
funders for the present study and, if
applicable, for the original study on which the
present article is based
 Reference
• Bias, Confounding and Effect Modification, Epidemiology Research Method from
https://onlinecourses.science.psu.edu/stat507/node/28
• Elm EV, Altman DG, Egger M, Pocock,SJ, Gotzsche PC, Vandenbroucke JP,1997,
STrengthening the Reporting of OBservational studies in Epidemiology(STROBE)
Statement: guideline for reporting observational studies, Bulletin of the World
Health Organization,85(11)
• Greenland S, 1996, Basic Methods for Sensitivity Analysis of Biases,International
Journal of Epidemiology
• Hill,BA, 1965, The Environment and Disease : Association or Causation,
Proceedings of the Royal Society of Medicine,58:295-300, from
https://edwardtufte.com/tufte/hill
• Mabikwa OV, Greenwood DC, Baxter PD, Flemming SJ,2017, Assessing the
reporting of categorized quantitative variables in observational epidemiological
studies,BMC Health Services Research 17:201.
• Sastroasmoro S, Ismael S, 2011, Dasar-Dasar Metodologi Penelitian Klinis, ed 4,
Jakarta : Sagung Seto.
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