STROBE STATEMENT

STRENGTHENING THE REPORTING

OF OBSERVATIONAL STUDIES IN
EPIDEMIOLOGY

DR. QASIM IDREES

 STROBE STATEMENT
• GUIDANCE ON HOW TO REPORT OBSERVATIONAL
STUDIES WELL (WHICH IS RARE!)
• FOCUS ON 3 MAIN STUDY DESIGNS: COHORT,
CASE-CONTROL, CROSS-SECTIONAL STUDIES
• PUBLISHED IN OCT 2007: SHORT PAPER AND E&E
• ADOPTED BY MANY JOURNALS

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OBSERVATIONAL STUDIES
Many types of studies - right research design
depends on the question we ask

Observational studies
•Large proportion of research
•Can be valuable (e.g. AE) but also many
disadvantages (confounding, bias)

Without comparison group – descriptive:

(do not try to qualify the relationships but give us a
perspective of what is happening in the population,
prevalence or experience of a group)
•Case reports, case series, qualitative
studies, some cross-sectional studies
(surveys)

With comparison group - analytical

(attempts to qualify relationship between two factors
– effect of an intervention / exposure on an outcome)
•Cohort studies, case-control studies, some
cross-sectional studies 3
 COHORT STUDIES

• COHORT = GROUP OF PEOPLES HAVING A

STATISTICAL FACTOR IN COMMON IN A
DEMOGRAPHIC STUDY
• START WITH EXPOSURE (VARIABLE) THEN FOLLOW
FOR OUTCOME
• DATA ARE OBTAINED FROM GROUPS WHO HAVE
BEEN EXPOSED OR NOT EXPOSED TO THE FACTOR
OF INTEREST
• BEST FOR STUDY THE EFFECT OF PREDICTIVE RISK
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FACTORS ON AN OUTCOME
 CASE-CONTROL STUDIES
• PATIENTS WITH A CERTAIN OUTCOME OR DISEASE AND
AN APPROPRIATE GROUP OF CONTROLS WITHOUT THE
OUTCOME OR DISEASE ARE SELECTED
(USUALLY WITH CAREFUL CONSIDERATION OF CHOICE
OF CONTROLS, MATCHING)
• INFORMATION IS OBTAINED ON WHETHER THE
PARTICIPANTS HAVE BEEN EXPOSED TO THE FACTOR
UNDER INVESTIGATION

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 CROSS-SECTIONAL
STUDIES
• EXAMINE THE RELATIONSHIP BETWEEN DISEASES
(OR OTHER HEALTH-RELATED CHARACTERISTICS)
AND OTHER VARIABLE OF INTEREST AS THEY EXIST
IN A DEFINED POPULATION AT ONE PARTICULAR TIME
(OUTCOMES AND EXPOSURES ARE BOTH MEASURED
AT THE SAME TIME)
• BEST FOR QUANTIFYING THE PREVALENCE OF A
DISEASE OR RISK FACTOR, AND FOR QUANTIFYING
THE ACCURACY OF A DIAGNOSTIC TEST
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 THREE STROBE EXTENSIONS (1)
• STREGA (2009)
• REPORTING OF GENETIC ASSOCIATION STUDIES

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 THREE STROBE EXTENSIONS (2)
• STROBE – ME (OCT 2011)
• REPORTING MOLECULAR EPIDEMIOLOGY (BIOMARKER
STUDIES)

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 THREE STROBE EXTENSIONS
(3)
• STROBE ABSTRACT
- REPORTING OBSERVATIONAL STUDIES IN CONFERENCE
ABSTRACTS (ONLINE DRAFT)

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 STROBE
• CHECKLIST WITH 22 ITEMS
• HEADING (WHERE IN PAPER), ITEM NO
• RECOMMENDATION, DIVIDED INTO:
COHORT, CASE-CONTROL, CROSS-SECTIONAL STUDY -
WHERE DIFFERENT

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TITLE AND ABSTRACT:
1.A) INDICATE THE STUDY’S DESIGN WITH A COMMONLY USED
TERM IN THE TITLE OR THE ABSTRACT

B) PROVIDE IN THE ABSTRACT AN INFORMATIVE AND BALANCED

SUMMARY OF WHAT WAS DONE AND WHAT WAS FOUND

INTRODUCTION
BACKGROUND/RATIONALE
2.EXPLAIN THE SCIENTIFIC BACKGROUND AND RATIONALE
FOR THE INVESTIGATION BEING REPORTED
OBJECTIVES
3. STATE SPECIFIC OBJECTIVES, INCLUDING ANY
PRESPECIFIED HYPOTHESIS
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METHODS:
STUDY DESIGN
4. PRESENT KEY ELEMENTS OF STUDY DESIGN
EARLY IN THE PAPER
(WHAT DESIGN, WHAT WAS COMPARED, WHICH
CONTROLS AND WHY...ETC)
SETTING
5. DESCRIBE THE SETTING, LOCATIONS, AND
RELEVANT DATES, INCLUDING PERIODS OF
RECRUITMENT, EXPOSURE, FOLLOW-UP, AND
DATA COLLECTION
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METHODS - CONTINUED
PARTICIPANTS
6.A) COHORT STUDY:
• ELIGIBILITY CRITERIA
• SOURCES AND METHODS OF PARTICIPANT SELECTION
• FOLLOW-UP METHODS

CASE-CONTROL STUDY:
• ELIGIBILITY CRITERIA
• SOURCES AND METHODS OF CASE ASCERTAINMENT AND CONTROL
SELECTION
• RATIONALE FOR THE CHOICES OF CASES AND CONTROLS

CROSS-SECTIONAL STUDY:
• ELIGIBILITY CRITERIA 13

• SOURCES AND METHODS OF PARTICIPANT SELECTION

METHODS - CONTINUED
PARTICIPANTS
6.B) COHORT STUDY:
FOR MATCHED STUDIES, GIVE MATCHING CRITERIA AND
NUMBER OF EXPOSED AND UNEXPOSED

CASE-CONTROL:
FOR MATCHED STUDIES, GIVE MATCHING CRITERIA AND THE
NUMBER OF CONTROLS PER CASE

VARIABLES
7. CLEARLY DEFINE ALL OUTCOMES, EXPOSURES,
PREDICTORS, POTENTIAL CONFOUNDERS,
AND EFFECT MODIFIERS. GIVE DIAGNOSTIC
CRITERIA, IF APPLICABLE
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METHODS - CONTINUED
DATA SOURCES/MEASUREMENT
8. 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 IN COHORT
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AND CROSS-SECTIONAL STUDIES

METHODS - CONTINUED
BIAS
9. DESCRIBE ANY EFFORTS TO ADDRESS
POTENTIAL SOURCES OF BIAS
(IF SYSTEMATIC DEVIATION OF A RESULT
FROM THE TRUE VALUE)
E.G.: RECALL BIAS, DETECTION BIAS,
INTERVIEWER BIAS, SELECTION
Very important
BIAS in observational
studies!
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METHODS - CONTINUED
STUDY SIZE
10. EXPLAIN HOW THE STUDY SIZE WAS ARRIVED
AT
(SHOULD BE LARGE ENOUGH TO ARRIVE AT A
POINT ESTIMATE WITH A REASONABLY NARROW
CONFIDENCE INTERVAL)

QUANTITATIVE VARIABLES
11. EXPLAIN HOW QUANTITATIVE VARIABLES
WERE HANDLED IN THE ANALYSES. IF APPLICABLE,
DESCRIBE WHICH GROUPINGS WERE CHOSEN AND 17

WHY
METHODS - CONTINUED
STATISTICAL METHODS
12.A) DESCRIBE ALL STATISTICAL METHODS,
INCLUDING THOSE USED TO CONTROL
CONFOUNDING
(≠BIAS, CONFOUNDING: ASSOCIATION TRUE
BUT CAUSED BY SOMETHING ELSE)

B) DESCRIBE ANY METHODS USED TO

EXAMINE SUBGROUPS AND INTERACTIONS

C) EXPLAIN HOW MISSING DATA WERE

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ADDRESSED
METHODS - CONTINUED
STATISTICAL METHODS - CONTINUED

12.D) COHORT STUDY:

IF APPLICABLE, EXPLAIN HOW LOSS TO FOLLOW-UP WAS
ADDRESSED

CASE-CONTROL:
IF APPLICABLE, EXPLAIN HOW MATCHING OF CASES AND
CONTROLS WAS ADDRESSED

CROSS-SECTIONAL:
IF APPLICABLE, DESCRIBE ANALYTICAL METHODS
INCLUDING SAMPLING STRATEGY
E) DESCRIBE ANY SENSITIVITY ANALYSES
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RESULTS
PARTICIPANTS
13. A) REPORT NUMBERS OF INDIVIDUALS AT EACH
STAGE OF STUDY - E.G., 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
* GIVE INFORMATION SEPARATELY FOR CASES AND CONTROLS IN
CASE-CONTROL STUDIES AND, IF APPLICABLE, FOR EXPOSED
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AND UNEXPOSED IN COHORT AND CROSS-SECTIONAL STUDIES
RESULTS - CONTINUED
DESCRIPTIVE DATA
14. A) GIVE CHARACTERISTICS OF STUDY PARTICIPANTS
(E.G. 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 (E.G. AVERAGE AND TOTAL
AMOUNT)

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* GIVE INFORMATION SEPARATELY FOR CASES AND CONTROLS IN CASE-
CONTROL STUDIES AND, IF APPLICABLE, FOR EXPOSED AND
RESULTS - CONTINUED
OUTCOME DATA
15. COHORT STUDY:
REPORT NUMBERS OF OUTCOME EVENTS OR SUMMARY
MEASURES OVER TIME

CASE-CONTROL:
REPORT NUMBERS IN EACH EXPOSURE CATEGORY, OR SUMMARY
MEASURES OF EXPOSURE

CROSS-SECTIONAL:
REPORT NUMBER OF OUTCOME EVENTS OR SUMMARY
MEASURES

* GIVE INFORMATION SEPARATELY FOR CASES AND CONTROLS IN CASE-

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CONTROL STUDIES AND, IF APPLICABLE, FOR EXPOSED AND
UNEXPOSED IN COHORT AND CROSS-SECTIONAL STUDIES
RESULTS - CONTINUED
MAIN RESULTS
16 A) GIVE UNADJUSTED ESTIMATES AND, IF APPLICABLE,
CONFOUNDER-ADJUSTED ESTIMATES AND
THEIR PRECISION (E.G. 95%CI). MAKE CLEAR WHICH
CONFOUNDERS WERE ADJUSTED FOR AND WHY
THEY WERE INCLUDED
B) REPORT CATEGORY BOUNDARIES WHEN
CONTINUOUS VARIABLES WERE CATEGORISED
C) IF RELEVANT, CONSIDER TRANSLATING ESTIMATES
OF RELATIVE RISK INTO ABSOLUTE RISK FOR A
MEANINGFUL TIME PERIOD
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RESULTS - CONTINUED
OTHER ANALYSES
17. REPORT OTHER ANALYSES DONE, E.G. ANALYSES OF
SUBGROUPS AND INTERACTIONS, AND SENSITIVITY ANALYSES
DISCUSSION
KEY RESULTS
18.SUMMARIZE KEY RESULTS WITH REFERENCE TO STUDY
OBJECTIVES

LIMITATIONS
19. DISCUSS LIMITATIONS OF THE STUDY, TAKING INTO ACCOUNT
SOURCES OF POTENTIAL BIAS OR IMPRECISION. DISCUSS BOTH
DIRECTION AND MAGNITUDE OF ANY POTENTIAL BIAS

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DISCUSSION - CONTINUED
INTERPRETATION
20. GIVE A CAUTIOUS OVERALL INTERPRETATION OF RESULTS
CONSIDERING OBJECTIVES, LIMITATIONS, MULTIPLICITY OF
ANALYSES, RESULTS FROM SIMILAR STUDIES, AND OTHER
RELEVANT EVIDENCE

GENERALISABILITY
21. DISCUSS THE GENERALISABILITY (EXTERNAL VALIDITY) OF
THE STUDY RESULTS

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OTHER INFORMATION
FUNDING
22.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

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THANK
YOU
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