Data Extraction Template for Cochrane Reviews
Introduction
The Cochrane Consumers & Communication Review Group has developed this template for its review
authors. The template is designed to capture relevant information about the types of interventions
covered within our Group’s scope, in order to facilitate the presentation of data in Cochrane systematic
reviews.
This template is to be used as a guide; review authors should revise it as appropriate for their
own review topic.
This template is for use with included studies only. It suggests elements which should be addressed in
the Characteristics of Included Studies table, Risk of Bias tables and Data and Analyses section in
RevMan 5. This template is most suited to the assessment of bias for RCTs; however, elements can be
adapted for use in the assessment of non-randomised studies, and we have indicated below how to
adapt the Risk of Bias tool for these types of studies. For Interrupted Time Series the data extraction
template may need substantial reworking (See the Review Group’s Study Quality Guide
(http://cccrg.cochrane.org/author-resources ) for more information).
Before finalising and piloting your own tailored data extraction form, read the Cochrane Handbook for
Systematic Reviews of Interventions (Chapter 7 “Selecting studies and collecting data”) which contains
further relevant instructions. For guidance on completing the assessment of risk of bias, you must refer
to the Cochrane Handbook (Chapter 8) and the Review Group’s Study Quality Guide
(http://cccrg.cochrane.org/author-resources) .
Notes on using a data extraction form:
 Be consistent in the order and style you use to describe the information…This will make it easier to
complete the Characteristics of Included Studies and Risk of Bias tables, prevent you from
overlooking information and make reading of the review easier.

When extracting this information, you should record the source of each piece of information,
including the precise location within a document.

Highlight any missing information as unclear or not described, to make it clear to the reader of your
review that the information was not included in the description of the study, not that you forgot to
extract it.

It may be reasonable to make assumptions about how the study was conducted, but these
assumptions must be reported by the review author for transparency

Supplement ambiguous quotes with ‘Probably done’ or ‘Probably not done’, providing a rationale for
the assumption.

Include instructions and decision rules on the data collection form. It is crucial that you practice
using the form and receive, or give, training if the form was designed by someone other than the
person using it. A cheat sheet containing decision rules and examples is very useful – particularly if
more than one review author is extracting data, to ensure consistency.

You must try to contact trial authors for any additional information or clarification required.. When
asking trial authors for more information about the study design and conduct, open ended questions
will reduce the risk of overly positive answers. See Cochrane Handbook section 8.3.4. Sample
letters to authors are available from the Managing Editor.
A note on record keeping:
Completed extraction sheets (paper or electronic) must be retained by the lead author to facilitate data
checking. These sheets should be made available to the Review Group editorial office upon request by
Version 1.5.0, updated 8 Feb 2013
the Managing Editor. These will be requested in select circumstances where it is unclear how data in
the review were derived.
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Form version/date (eg. Version 1.4, 5 August 2011)
Review Title
Study ID (Surname Year: as it will appear in RevMan)
Name of review author completing this form
Date form completed
Notes (Unpublished – for own use)
Eg. References to be followed up, source of information (especially if multiple reports of same trial, or
unpublished data/personal communication included).
Methods:
Details of Study
Aim of intervention (As stated in the trial report/s. What was the problem that this intervention was
designed to address?)
Aim of study (As stated in the trial report/s. What was the trial designed to assess?)
Study design
Methods of recruitment of participants (How were potential participants approached and invited to
participate?)
Inclusion/exclusion criteria for participation in study
Informed consent obtained? (Yes/No/Unclear)
Ethical approval (Yes/No/Unclear)
Funding (including source, amount, if stated).
Statistical methods and their appropriateness (if relevant)
Consumer involvement (eg. In design of study and/or intervention; in delivery of intervention; in
evaluation of intervention; in interpretation of study findings)
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Assessment of Risk of Bias for RCTs, quasi-RCTs and CBAs (used to complete the ‘Risk of
Bias’ tables in RevMan 5.)
Adapted from Cochrane Handbook Table 8.5.a: The Cochrane Collaboration’s tool for
assessing risk of bias

NOTES:
For details on how to complete this section, you must refer to the Cochrane Handbook, chapter
8, particularly Table 8.5.c.

If you are including quasi-RCT and CBA study designs, you will need to complete the Risk of
Bias tool in a particular way for those studies (see next page).

For ITS studies you should utilise the Review Group’s amended Risk of Bias tool as outlined in
the Study Quality Guide (http://cccrg.cochrane.org/author-resources)

For tips on how to enter data into RevMan 5, see “Risk of Bias” tables in the RevMan User
Guide.
Domain
Review authors’
judgement
High risk
Random sequence
generation*
Unclear
Low risk
Support for judgement
Describe the method used to generate the
allocation sequence in sufficient detail to
allow an assessment of whether it should
produce comparable groups.
Quasi-RCTs and Controlled Before and After
(CBA) studies must be rated as ‘High Risk’ for
random sequence generation as the methods
were not, by definition, truly random.
If you are including only RCTs in your review,
papers marked ‘high risk’ should be excluded
as they are not truly randomised.
High risk
Allocation concealment
Unclear
Low risk
Blinding of participants and
personnel
Assessments should be made
for each main outcome (or
class of outcomes).
Blinding of outcome
assessment
Assessments should be made
for each main outcome (or
class of outcomes).
High risk
Unclear
Low risk
High risk
Unclear
Low risk
Describe the method used to conceal the
allocation sequence in sufficient detail to
determine whether intervention allocations
could have been foreseen in advance of, or
during, enrolment.
CBA Studies should be rated ‘High Risk.
Quasi-RCTs are likely to be rated ‘High Risk
but there may be some exceptions.
Describe all measures used, if any, to blind
study participants and personnel from
knowledge of which intervention a
participant received. Provide any
information relating to whether the
intended blinding was effective.
Describe all measures used, if any, to blind
outcome assessors from knowledge of
which intervention a participant received.
Provide any information relating to
whether the intended blinding was
effective. If the outcome is objective (eg.
length of hospital stay) the rating should be
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‘Low risk.
Incomplete outcome data
Assessments should be made
for each main outcome (or
class of outcomes).
High risk
Unclear
Low risk
Selective reporting
High risk
Unclear
Describe the completeness of outcome
data for each main outcome, including
attrition and exclusions from the analysis.
State whether attrition and exclusions
were reported, the numbers in each
intervention group (compared with total
randomized participants), reasons for
attrition/exclusions where reported, and
any re-inclusions in analyses performed
by the review authors.
State how the possibility of selective
outcome reporting was examined by the
review authors, and what was found.
Low risk
Other sources of bias
See the Cochrane Handbook
8.15.1 for further examples of
potential threats to validity, as
well as 16.3.2 for issues
relating to cluster trials and
16.4.3 for cross-over trials.
Note: all answers
should follow the
format:
State any important concerns about bias
not addressed in the other domains in the
tool.
High risk
If particular questions/entries were prespecified in the review’s protocol,
responses should be provided for each
question/entry.
Unclear
Low risk
Participants:
Description (eg. Patients/consumers; carers; parents of patients/consumers; health professionals; well
people in the community)
Geographic location (eg. City/State/Country)
Setting (eg. Community, home, primary health centre, acute care hospital, extended care facility)
Number: (Eligible, excluded, refused to take part, randomised to intervention, randomised to control,
excluded post randomisation, withdrawn, lost to follow up, died, included in analysis, included for each
outcome)
Age: range, mean (standard deviation)
Gender
Ethnicity
Principal health problem or diagnosis (if relevant)
Other health problem/s (if relevant)
Stage of problem/illness (if relevant)
Treatment received/receiving
Other social/demographic details (eg. literacy or reading level)
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Interventions:
Details of intervention, including theoretical basis (with key references), aim, content, format(s) (media),
source, setting. (Capture this information for each arm of the study, eg. Intervention A, Intervention
B…)
Details of control/usual or routine care
Details of co-interventions in all groups (co-interventions may be separate to the intervention of interest
for this review, or they may be other similar elements in a suite of interventions having a common
purpose. Record all relevant information).
Delivery of intervention (eg. stages, timing, frequency, duration) (for each intervention included in the
study, eg. Intervention A; Intervention B…)
Details of providers (Who delivers the intervention?; number of providers; training of providers in
delivery of intervention).
Intervention quality (if relevant): (Record any information on the quality of the intervention - assessed
by study authors, others, or by you - such as the evidence base of the intervention, or the quality of staff
training for intervention delivery)
Fidelity/integrity (Was the intervention delivered as intended? Record any assessment of this).
Outcomes:
Principal and secondary outcome measures (as identified by the study authors).
Methods of assessing outcome measures (eg, phone survey, questionnaire, physical measurements
(for each outcome))
Validity and reliability of outcome measures
Methods of follow-up for non-respondents
Timing of outcome assessment (including frequency, length of follow up (for each outcome))
Adverse events (eg complaints, levels of dissatisfaction, adverse incidents, side effects))
Notes (These are published in the table Characteristics of Included Studies)
For example:

Contact with author (Yes (information obtained)/No) (SEE NOTE ON PAGE 1)

Power calculation?

Record if the study was translated from a language other than English.

Record if the study was a duplicate publication.
Results
These data will be used in the “Comparisons and Data” section in RevMan (not the table
“Characteristics of Included Studies”) and as the basis for the “Results” section of your review text.
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All data are numbers (of patients/units), not percentages.
Dichotomous outcomes
Outcome
Timing of
outcome
assessment
(days/months)
Intervention group*
Observed
Total (N)
(n)
Control group
Observed
Total (N)
(n)
Notes
*Note: add additional columns if there is more than one intervention group, eg. Intervention Group A,
Intervention Group B…
Continuous outcomes
Outcome
Timing of
outcome
assessment
(days/months)
Intervention group
*Mean /
Mean
change
Standard
deviation
Control group
N
*Mean /
Mean
change
Standard
deviation
Notes
N
*delete as appropriate
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