Data collection form
Intervention review – RCTs only
This form can be used as a guide for developing your own data extraction form. Sections can be
expanded and added, and irrelevant sections can be removed. It is difficult to design a single form that
meets the needs of all reviews, so it is important to consider carefully the information you need to
collect, and design your form accordingly. Information included on this form should be comprehensive,
and may be used in the text of your review, ‘Characteristics of included studies’ table, risk of bias
assessment, and statistical analysis.
Notes on using a data extraction form:
Be consistent in the order and style you use to describe the information for each report.
Record any missing information as unclear or not described, to make it clear that the
information was not found in the study report(s), not that you forgot to extract it.
Include any instructions and decision rules on the data collection form, or in an accompanying
document. It is important to practice using the form and give training to any other authors using
the form.
Review title or ID
Study ID (surname of first author and year first full
report of study was published e.g. Smith 2001)
Report ID
Report ID of other reports of this study
Notes
General Information
Date form completed
(dd/mm/yyyy)
Name/ID of person extracting
data
Reference citation
Study author contact details
Publication type
(e.g. full report, abstract, letter)
Notes:
535090633.doc
Study eligibility
Study Eligibility criteria Eligibility criteria met? Location in text or
Characteristics source (pg &
(Insert inclusion criteria for each ¶/fig/table/other)
characteristic as defined in the Protocol) Yes No Unclear
Type of study Randomised Controlled Trial
Quasi-randomised Controlled Trial
Participants
Types of
intervention
Types of
comparison
Types of
outcome
measures
INCLUDE EXCLUDE
Reason for
exclusion
Notes:
DO NOT PROCEED IF STUDY EXCLUDED FROM REVIEW
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Characteristics of included studies
Methods
Descriptions as stated in report/paper Location in text
or source (pg &
¶/fig/table/other
)
Aim of study (e.g.
efficacy, equivalence,
pragmatic)
Design(e.g. parallel,
crossover, non-RCT)
Unit of allocation
(by individuals,
cluster/ groups or
body parts)
Start date
End date
Duration of
participation
(from recruitment to
last follow-up)
Ethical approval
needed/ obtained for
study Yes No Unclear
Notes:
3
Participants
Description Location in text or
source (pg &
Include comparative information for each intervention or ¶/fig/table/other
comparison group if available )
Population description
(from which study
participants are drawn)
Setting
(including location and
social context)
Inclusion criteria
Exclusion criteria
Method of recruitment
of participants (e.g.
phone, mail, clinic
patients)
Informed consent
obtained
Yes No Unclear
Total no. randomised
(or total pop. at start of
study for NRCTs)
Clusters
(if applicable, no., type,
no. people per cluster)
Baseline imbalances
Withdrawals and
exclusions
(if not provided below
by outcome)
Age
Sex
Race/Ethnicity
Severity of illness
4
Co-morbidities
Other relevant
sociodemographics
Subgroups measured
Subgroups reported
Notes:
5
Intervention groups
Copy and paste table for each intervention and comparison group
Intervention Group 1
Description as stated in report/paper Location in text or
source (pg &
¶/fig/table/other
)
Group name
No. randomised to group
(specify whether no.
people or clusters)
Theoretical basis (include
key references)
Description (include
sufficient detail for
replication, e.g. content,
dose, components)
Duration of treatment
period
Timing (e.g. frequency,
duration of each episode)
Delivery (e.g. mechanism,
medium, intensity, fidelity)
Providers
(e.g. no., profession,
training, ethnicity etc. if
relevant)
Co-interventions
Economic information
(i.e. intervention cost,
changes in other costs as
result of intervention)
Resource requirements
(e.g. staff numbers, cold
chain, equipment)
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Integrity of delivery
Compliance
Notes:
Outcomes
Copy and paste table for each outcome.
Outcome 1
Description as stated in report/paper Location in text or
source (pg &
¶/fig/table/other
)
Outcome name
Time points measured
(specify whether from
start or end of
intervention)
Time points reported
Outcome definition (with
diagnostic criteria if
relevant)
Person measuring/
reporting
Unit of measurement
(if relevant)
Scales: upper and lower
limits (indicate whether
high or low score is
good)
Is outcome/tool
validated?
Yes No Unclear
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Imputation of missing
data
(e.g. assumptions made
for ITT analysis)
Assumed risk estimate
(e.g. baseline or
population risk noted in
Background)
Power (e.g. power &
sample size calculation,
level of power achieved)
Notes:
Other
Study funding sources
(including role of funders)
Possible conflicts of interest
(for study authors)
Notes:
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Data and analysis
Copy and paste the appropriate table for each outcome, including additional tables for each time point
and subgroup as required.
Dichotomous outcome
Description as stated in report/paper Location in text
or source (pg &
¶/fig/table/oth
er)
Comparison
Outcome
Subgroup
Time point
(specify from start or end
of intervention)
Results Intervention Comparison
No. with Total in No. with Total in
event group event group
Any other results
reported (e.g. odds ratio,
risk difference, CI or P
value)
No. missing participants
Reasons missing
No. participants moved
from other group
Reasons moved
Unit of analysis (by
individuals,
cluster/groups or body
parts)
9
Statistical methods used
and appropriateness of
these (e.g. adjustment
for correlation)
Reanalysis required?
(specify, e.g. correlation
adjustment) Yes No Unclear
Reanalysis possible?
Yes No Unclear
Reanalysed results
Notes:
For RCT/CCT
Continuous outcome
Description as stated in report/paper Location in text or
source (pg &
¶/fig/table/other)
Comparison
Outcome
Subgroup
Time point
(specify from start or
end of intervention)
Post-intervention or
change from
baseline?
Results Intervention Comparison
Mean SD (or No. Mean SD (or No.
other participants other participan
variance, variance, ts
specify) specify)
10
Any other results
reported (e.g. mean
difference, CI, P value)
No. missing
participants
Reasons missing
No. participants
moved from other
group
Reasons moved
Unit of analysis
(individuals, cluster/
groups or body parts)
Statistical methods
used and
appropriateness of
these (e.g.
adjustment for
correlation)
Reanalysis required?
(specify)
Yes No Unclear
Reanalysis possible?
Yes No Unclear
Reanalysed results
Notes:
Continuous outcome
Description as stated in report/paper Location in text or
source (pg &
¶/fig/table/other)
Comparison
Outcome
11
Subgroup
Time point
(specify from start or
end of intervention)
Post-intervention or
change from
baseline?
Results Intervention Comparison
Mean SD (or No. Mean SD (or No.
other participants other particip
variance, variance, ants
specify) specify)
Any other results
reported (e.g. mean
difference, CI, P value)
No. missing
participants
Reasons missing
No. participants
moved from other
group
Reasons moved
Unit of analysis
(individuals, cluster/
groups or body parts)
Statistical methods
used and
appropriateness of
these (e.g.
adjustment for
correlation)
12
Reanalysis required?
(specify)
Yes No
Unclear
Reanalysis possible?
Yes No
Unclear
Reanalysed results
Notes:
Other outcome
Description as stated in report/paper Location in text or
source (pg &
¶/fig/table/other)
Comparison
Outcome
Subgroup
Time point
(specify from start or end
of intervention)
No. participants Intervention Control
Results Intervention SE (or other Control SE (or
result variance) result other
variance)
Overall results SE (or other variance)
Any other results
reported
No. missing participants
Reasons missing
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No. participants moved
from other group
Reasons moved
Unit of analysis (by
individuals,
cluster/groups or body
parts)
Statistical methods used
and appropriateness of
these
Reanalysis required?
(specify)
Yes No
Unclear
Reanalysis possible?
Yes No
Unclear
Reanalysed results
Notes:
Other information
Description as stated in report/paper Location in text
or source (pg &
¶/fig/table/othe
r)
Key conclusions of study
authors
References to other
relevant studies
Correspondence required
for further study
information (from whom,
what and when)
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Notes:
15
Definitions
Assumed risk estimate An estimate of the risk of an event or average score without the intervention,
used in Cochrane 'Summary of findings tables'. If a study provides useful
estimates of the risk or average score of different subgroups of the
population, or an estimate based on a representative observational study, you
may wish to collect this information.
Bias A systematic error or deviation in results or inferences from the truth. In
studies of the effects of health care, the main types of bias arise from
systematic differences in the groups that are compared (selection bias), the
care that is provided, exposure to other factors apart from the intervention of
interest (performance bias), withdrawals or exclusions of people entered into
a study (attrition bias) or how outcomes are assessed (detection bias).
Reviews of studies may also be particularly affected by reporting bias, where a
biased subset of all the relevant data is available.
Change from baseline A measure for a continuous outcome calculated as the difference between
the baseline score and the post-intervention score.
Clusters A group of participants who have been allocated to the same intervention arm
together, as in a cluster-randomised trial, e.g. a whole family, town, school or
patients in a clinic may be allocated to the same intervention rather than
separately allocating each individual to different arms.
Co-morbidities The presence of one or more diseases or conditions other than those of
primary interest. In a study looking at treatment for one disease or condition,
some of the individuals may have other diseases or conditions that could
affect their outcomes.
Compliance Participant behaviour that abides by the recommendations of a doctor, other
health care provider or study investigator (also called adherence or
concordance).
Contemporaneous data When data are collected at the same point(s) in time or covering the same
collection time period for each intervention arm in a study (that is, historical data are
not used as a comparison).
Exclusions Participants who were excluded from the study or the analysis by the
investigators.
Imputation Assuming a value for a measure where the true value is not available (e.g.
assuming last observation carried forward for missing participants).
Integrity of delivery The degree to which the specified procedures or components of an
intervention are delivered as originally planned.
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Post-intervention The value of an outcome measured at some time point following the
beginning of the intervention (may be during or after the intervention period).
Power In clinical trials, power is the probability that a trial will obtain a statistically
significant result when the true intervention effect is a specified size. For a
given size of effect, studies with more participants have greater power. Note
that power should not be considered in the risk of bias assessment.
Providers The person or people responsible for delivering an intervention and related
care, who may or may not require specific qualifications (e.g. doctors,
physiotherapists) or training.
Quasi-randomised A study in which the method of allocating people to intervention arms was
controlled trial not random, but was intended to produce similar groups when used to
allocate participants. Quasi-random methods include: allocation by the
person's date of birth, by the day of the week or month of the year, by a
person's medical record number, or just allocating every alternate person.
Reanalysis Additional analysis of a study's results by a review author (e.g. to introduce
adjustment for correlation that was not done by the study authors).
Report ID A unique ID code given to a publication or other report of a study by the
review author (e.g. first author's name and year of publication). If a study has
more than one report (e.g. multiple publications or additional unpublished
data) a separate Report ID can be allocated to each to help review authors
keep track of the source of extracted data.
Sociodemographics Social and demographic information about a study or its participants,
including economic and cultural information, location, age, gender, ethnicity,
etc.
Study ID A unique ID code given to an included or excluded study by the review author
(e.g. first author's name and year of publication from the main report of the
study). Although a study may have multiple reports or references, it should
have one single Study ID to help review authors keep track of all the different
sources of information for a study.
Theoretical basis The use of a particular theory (such as theories of human behaviour change)
to design the components and implementation of an intervention
Unit of allocation The unit allocated to an intervention arm. In most studies individual
participants will be allocated, but in others it may be individual body parts
(e.g. different teeth or joints may be allocated separately) or clusters of
multiple people.
Unit of analysis The unit used to calculate N in an analysis, and for which the result is
reported. This may be the number of individual people, or the number of
body parts or clusters of people in the study.
Unit of measurement The unit in which an outcome is measured, e.g. height may be measured in
cm or inches; depression may be measured using points on a particular scale.
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Validation A process to test and establish that a particular measurement tool or scale is a
good measure of that outcome.
Withdrawals Participants who voluntarily withdrew from participation in a study before the
completion of outcome measurement.
Sources:
Cochrane Collaboration Glossary, 2010. Available from http://www.cochrane.org/training/cochrane-
handbook.
Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version
5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-
handbook.org.
Last JM (editor), A Dictionary of Epidemiology, 4 th Ed. New York: Oxford University Press, 2001.
Schünemann H, Brożek J, Oxman A, editors. GRADE handbook for grading quality of evidence and
strength of recommendation. Version 3.2 [updated March 2009]. The GRADE Working Group, 2009.
Available from http://www.cc-ims.net/gradepro.
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