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Content-Location: file:///C:/2209C636/Observational_data_Betran_2006_files/pres.xml
Content-Transfer-Encoding: quoted-printable
Content-Type: text/xml; charset="utf-8"
Makin=
g a
difference in countries
Depar=
tment
of Making Pregnancy Safer
Systematic
reviews of observational data
Dr
Ana Pilar Betrán
Department
of Making Pregnancy Safer
World
Health Organization
Training
Course in Reproductive Health / Sexual Health Research
Geneva 2=
006
Makin=
g a
difference in countries
Depar=
tment
of Making Pregnancy Safer
“Epidemiologist kno=
w a
lot about the correct way to conduct a
research study but less about how to review <=
span
style=3D'position:absolute;top:39.75%;left:15.54%;width:85.95%;height:7.0%=
'>and
synthesize data from multiple studies and this, I
suggest, is a principal source of the publ=
ic’s
confusion when faced with a new result
from an epidemiological study”
Bracken MB. IJE 2001:954
Making a difference in countries=
Department of Making Pregnancy Safer=
What is a systematic review?=
=
=
üc=
learly
formulated question
A review:
=
=
<=
span
style=3D'font-family:Verdana'>üuses systematic and explicit methods t=
o identify and collect =
relevant
research
=
=
<=
span
style=3D'font-family:Verdana'>üuses systematic and explicit methods t=
o select, critically appraise =
and analyse relevant research included.<=
/div>
Making a difference in countries=
Department of Making Pregnancy Safer=
Statistical
methods (meta-analysis) may or may not be used to =
summarise the re=
sults
of the included =
studies
What is a systematic review=
?
<=
/div>
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Making a difference in countries=
Department of Making Pregnancy Safer=
How much work =
is a
systematic review?
=
=
ü5=
88 for
protocol, searching and retrieval
=
ü144 for statistical analysis
ü206 for report writing
ü201 for administration
~ 1139 hours
~ 30 person-weeks of full-time work
=
Source:
Allen IE. JAMA, 1999;282:634
Making a difference in countries=
Department of Making Pregnancy Safer=
What are observational studies?
=
=
<=
span
style=3D'font-family:Verdana'>üData from existing database
<=
span
style=3D'font-family:Verdana'>üCross-sectional study
<=
span
style=3D'font-family:Verdana'>üCase series
<=
span
style=3D'font-family:Verdana'>üCase-control study
<=
span
style=3D'font-family:Verdana'>üCohort study
Making a difference in countries=
Department of Making Pregnancy Safer=
RCT
Observational studies=
3;
Making a difference in countries=
Department of Making Pregnancy Safer=
Randomized controlled trials=
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Content-Location: file:///C:/2209C636/Observational_data_Betran_2006_files/slide0033.htm
Content-Transfer-Encoding: quoted-printable
Content-Type: text/html; charset="windows-1252"
Making a difference in countries=
Department of Making Pregnancy Safer=
=
Why do
we need systematic reviews =
of
observational studies?
=
=
üT=
est
aetiological hypothesis
=
üE=
valuation
of interventions designed to prevent rare outcomes&#=
13;
<=
span
style=3D'mso-special-format:bullet;color:#CC9900;mso-color-index:4;positio=
n:
absolute;left:-7.5%;top:.49em;font-family:Wingdings;font-size:65%'>üE=
valuation
if outcomes of interest are far in the
future
=
üE=
valuation
of effectiveness in a community
Making a difference in countries=
Department of Making Pregnancy Safer=
MAOS are common
Source:
Egger M. Systematic reviews in Health Care. Meta-analysis in =
context.
BMJ Books. 2001
Making a difference in countries=
Department of Making Pregnancy Safer=
(=
Lack of
precision)
nMeta-analysis
nMore reliable estimates
RCT
Making a difference in countries=
Department of Making Pregnancy Safer=
Observational studies
(Confounding, bias)
nMeta-analysis
nMore reliable estimates????
Making a difference in countries=
Department of Making Pregnancy Safer=
Smoking
Suicide
![](3D"slide0037_image008.png")
Social/mental
states
Confounding factors<=
/span>
<=
/div>
Making a difference in countries=
Department of Making Pregnancy Safer=
Coffee consumption
Risk of myocardial infarction
![](3D"slide0038_image009.png")
Smoking
Confounding factors
<=
/div>
Making a difference in countries=
Department of Making Pregnancy Safer=
The protecti=
ve
effect of beta-carotene that wasn’t
Cohorts
Male health workers
Social insurance, men
Social insurance, women
Male chemical workers
Hyperlipidaemic men
Nursing home residents
Trials
Male smokers
Skin cancer patients
(Ex)-smokers, asbestos =
=
workers
Male physicians
Making a difference in countries=
Department of Making Pregnancy Safer=
But observational studies =
will
always have to deal with bias and confoundi=
ng
because the intervention was deliberately chosen =
and
not randomly allocated
There are examples=
of
observational studies producing similar
results of those from RCT
Making a difference in countries=
Department of Making Pregnancy Safer=
=
Benson
and Hartz,
NEJM, 2000;342:1878-86
NEJM, 2000;342:1878-86
Making a difference in countries=
Department of Making Pregnancy Safer=
=
Concato
et al.,
NEJM, 2000;342:1887-92=
NEJM, 2000;342:1887-92=
Makin=
g a
difference in countries
Depar=
tment
of Making Pregnancy Safer
This does not mean to return to =
narrative re=
views
Makin=
g a
difference in countries
Depar=
tment
of Making Pregnancy Safer
Benefits of MAOS:
=
=
<=
span
style=3D'font-family:Verdana'>üSystematic and explicit rules
<=
span
style=3D'font-family:Verdana'>üStatistical power
<=
span
style=3D'font-family:Verdana'>üInsight into variable interaction
<=
span
style=3D'font-family:Verdana'>üDetection of discrepancies
<=
span
style=3D'font-family:Verdana'>üDeepness into heterogeneity
<=
span
style=3D'font-family:Verdana'>üIdentification of gaps in knowledge<=
/span>
Making a difference in countries=
Department of Making Pregnancy Safer=
Reporting of
background should include:
=
=
=
1P=
roblem
definition, hypothesis statement
=
<=
span
style=3D'font-family:Verdana'>2D=
escription
of study outcome(s)
3T=
ype of
exposure or intervention used
<=
span
style=3D'font-family:Verdana'>4T=
ype of
study designs used
<=
span
style=3D'font-family:Verdana'>5S=
tudy
population
<=
/div>
Making a difference in countries=
Department of Making Pregnancy Safer=
6 Qualifications of researchers
7 Search strategy including time period=
8 Effort to include all available
studies
9 Databases and registries searched
=
;
10
Searching software used
11=
Use
of hand searching
12=
List
of citations located and those excluded, including =
justification
13
Methods of addressing articles not published in English
=
14
Methods of handling abstracts and unpublished studies
15
Descriptions of any contact with authors
Reporting of search should
include:
Making a difference in countries=
Department of Making Pregnancy Safer=
16 Description of
relevance/appropriateness of papers =
assembled for assessing the
hypothesis to be tested
17 Rational for the selection a=
nd
coding of data
18 Documentation about how data
were classified and coded
19 Assessment of confounding=
3;
20 Assessment of study quality,
including blinding of =
quality
assessors; stratification or regression on possible predictors of study results
21 Assessment of heterogeneity&=
#13;
22 Description of statistical
methods in sufficient detail to =
be replicated
23 Provision of appropriate tab=
les
and graphics
Reporting of methods should
include:
Making a difference in countries=
Department of Making Pregnancy Safer=
24
Graphic summarizing individual study =
estimat=
es and
overall estimate
25
Table giving descriptive information for =
each s=
tudy
included
26
Results of sensitivity testing (e.g.
<=
span
style=3D'position:absolute;top:65.5%;left:9.92%;width:84.26%;height:6.0%'>=
subgro=
up
analysis)
27
Indication of statistical uncertainty of =
findin=
gs
Reporting of results should
include:
Making a difference in countries=
Department of Making Pregnancy Safer=
28 <=
span
lang=3DEN-GB style=3D'font-family:Verdana;mso-ascii-font-family:Verdana'>Q=
uantitative
assessment of bias
29
Justification for exclusion
30
Assessment of quality of included studies
Reporting of discussi=
on
should include:
Making a difference in countries=
Department of Making Pregnancy Safer=
31
Consideration of alternative explanations for obs=
erved
results
32
Generalization of the conclusions
33
Guidelines for future research
34
Disclosure of funding source
Reporting of conclusions should
include:
Making a difference in countries=
Department of Making Pregnancy Safer=
Quality of reviews in
Epidemiology
Breslow R. AJPH, 1998;88:475-7
Breslow R. AJPH, 1998;88:475-7
All
1995 issues of 7 widely read epidemiology journals were searched for reviews
29
reviews were found
Making a difference in countries=
Department of Making Pregnancy Safer=
Reviews following quality
guidelines
Making a difference in countries=
Department of Making Pregnancy Safer=
=
Search
restriction:
General medical journal, 2001=
General medical journal, 2001=
1
(8%)
4
(21%)
All
Methods Employed
4
(31%)
8
(42%)
Cochrane
Databases Searched
2
(15%)
7
(37%)
Contacted
Experts to Find Unpu=
blished
Data
4
(31%)
5
(26%)
Gray
Literature Searched
=
<=
span
style=3D'font-size:77%'>(e.g., manual search of conference <=
span
style=3D'position:absolute;top:62.25%;left:4.49%;width:45.69%;height:4.5%'=
>or dissertation abstracts)
10
(77%)
17
(89%)
Additional
Searches Conducted
<=
span
style=3D'font-size:77%'>(e.g., manual search of reference lists or textbooks)
6 (46%)
13 (68%)
Numerous Databases Searched
<=
span
style=3D'font-family:Arial;mso-ascii-font-family:Arial;mso-bidi-font-famil=
y:
"Times New Roman";font-size:77%'>(versus just MEDLINE)
13 systematic reviews
19 meta-analyses
Search Procedure
=
Source:
Becker B, Morton S (see
http://www.msri.org/calendar/talks/TalkInfo/1268/show_talk)
Making a difference in countries=
Department of Making Pregnancy Safer=
=
Search
restriction:
General medical journal, 2001=
General medical journal, 2001=
5
(38%)
7
(37%)
Attempted
to include un=
published
studies
5
(38%)
4
(21%)
Unclear
7
(54%)
7
(37%)
English only
0
(0%)
2
(11%)
English plus other lang.=
1 (8%)
6 (32%)
None
13 systematic reviews
19 meta-analyses
Language Restriction
=
Source:
Becker B, Morton S (see
http://www.msri.org/calendar/talks/TalkInfo/1268/show_talk)
Making a difference in countries=
Department of Making Pregnancy Safer=
Other citations:
=
=
üMulrow CD. The medical review article: state of the science. Ann Intern Med=
1987, 6:233-240.
=
=
üMcAlister FA, Clark HD, van Walraven C et al. The medical review article revisited: =
has the science improved? =
Ann
Intern Med 1999, 131:947-951
=
üBracken MB. Commentary: towards systematic reviews in epidemiology. =
IJE 2001, 30:954-957.
Making a difference in countries=
Department of Making Pregnancy Safer=
Summary
=
=
üSR and MA of observational
studies are as common as reviews of
RCT
üConfounding and selection bias
often distort the findings
üDanger in producing very prec=
ise
but spurious results
<=
/span>
üMore is gained by examining <=
/span>heterogeneity
Making a difference in countries=
Department of Making Pregnancy Safer=
WHO Systematic review of incidence/prevalence
of maternal mortality and morbidity
1997-2002
Making a difference in countries=
Department of Making Pregnancy Safer=
Objectives
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nTo
provide a comprehensive, standardised a=
nd
reliable tabulation of available data=
on
maternal morbidity
nTo
provide up-to-date data for future maternal morta=
lity
estimates
nTo
provide case-fatality rates
Making a difference in countries=
Department of Making Pregnancy Safer=
=
WHO
systematic review
Making a difference in countries=
Department of Making Pregnancy Safer=
WHO systematic review
Making a difference in countries=
Department of Making Pregnancy Safer=
WHO systematic review
Making a difference in countries=
Department of Making Pregnancy Safer=
WHO systematic review
Making a difference in countries=
Department of Making Pregnancy Safer=
WHO s=
ystematic
review
Making a difference in countries=
Department of Making Pregnancy Safer=
Reasons for =
=
exc=
lusion
·57%<=
/b> – =
no =
rel=
evant
data
·15%<=
/b> – =
=
sam=
ple =
siz=
e<200
·11%<=
/b> – =
no =
dat=
es
reported
·17%<=
/b> – =
other =
rea=
sons
Making a difference in countries=
Department of Making Pregnancy Safer=
Regional
distribution (n=3D2204)
Making a difference in countries=
Department of Making Pregnancy Safer=
Development status (n=3D2204)=
Making a difference in countries=
Department of Making Pregnancy Safer=
Results: methodological quality of reported data
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Making a difference in countries=
Department of Making Pregnancy Safer=
Reported morbidities (n=3D3215)
üHypertensive disorders of pregnancy (16.3%)
<=
/div>
Systematic reviews of observational data - Ana Pilar Betrán
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üHaemorrhage (11.1%)
üpostpartum - 2.7%
<=
/div>
------=_NextPart_01C63C9C.E7855EC0
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Content-Transfer-Encoding: quoted-printable
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üantepartum / intrapartum - 2.2%
üplacenta praevia - 1.8%
üabruptio placenta - 2.6%
<=
/span>
üother haemorrhage / unspecified - 1.8%
=
üAbortion (10.7%)
üPreterm delivery (8.3%)=
<=
span
style=3D'font-size:111%;text-shadow:auto'>üStillbirth (6.3%)&#=
13;
<=
span
style=3D'font-size:111%;text-shadow:auto'>ü=
Diabetes in pregnan=
cy
(4.4%)
<=
span
style=3D'font-size:111%;text-shadow:auto'>ü=
Anaemia in pregnanc=
y (4.3%)
<=
span
style=3D'font-size:111%;text-shadow:auto'>üEctopic pregnancy
(3.0%)
<=
span
style=3D'font-size:111%;text-shadow:auto'>üPerineal tears (2.6=
%)
<=
span
style=3D'font-size:111%;text-shadow:auto'>üPROM (2.6%)
<=
span
style=3D'font-size:111%;text-shadow:auto'>üUterine rupture (2.=
1%)
<=
span
style=3D'font-size:111%;text-shadow:auto'>üPostpartum sepsis
(1.6%)
<=
span
style=3D'font-size:111%;text-shadow:auto'>üDepression (1.9%)&#=
13;
<=
span
style=3D'font-size:111%;text-shadow:auto'>üObstructed labour (=
1.8%)
Making a difference in countries=
Department of Making Pregnancy Safer=
William Hamilton, New Yorker, 2001