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Collecting data
Jacqueline Dinnes, Jonathan J. Deeks, Mariska M. Leeflang and Tianjing Li
KEY POINTS
Systematic reviews have studies, rather than reports, as the unit of interest. Multiple
•
reports of the same study need to be identified and linked together, and multiple studies
in the same report need to be separated.
Studies may be published or unpublished, available as pre- prints or in trial registers,
•
regulatory documents or clinical study reports. Where studies are reported in multiple
sources, plans are needed to resolve discrepancies if information is inconsistent.
Data extraction includes collection of study characteristics, methodological detail
•
needed to assess study quality, as well as study findings. The key to successful data
collection is to construct easydata that faithfully represent the source in a structured and organized manner.
Review authors are encouraged to develop outlines of tables and figures that will
•
appear in the review to facilitate the design of data collection forms.
Effort should be made to identify and structure data needed for meta- analyses,
•
including 2×2data and relevant covariates for heterogeneity investigations or sensitivity
analyses. Study data may need to be calculated or converted from data reported in
diverse formats.
Review authors should choose a data collection tool that is suited to the review type,
•
team size and resources available.
Duplicate independent data extraction is recommended for critical data items, such
•
as study findings and where subjective judgement is involved. Double- checking of all
data extraction and data entry is strongly recommended.
Data should be collected and archived in a form that allows future access and data
•
sharing.
to- use forms and collect sufficient and unambiguous
This chapter should be cited as: Dinnes J, Deeks JJ, Leeflang MM, Li T. Chapter7: Collecting data. In: Deeks JJ,
Bossuyt PM, Leeflang MM, Takwoingi Y, editors. Cochrane Handbook for Systematic Reviews of Diagnostic Test
Accuracy. 1st edition. Chichester (UK): John Wiley & Sons, 2023: 131–168.
Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy, First Edition. Edited by
Jonathan J. Deeks, Patrick M. Bossuyt, Mariska M. Leeflang and Yemisi Takwoingi.
© 2023 The Cochrane Collaboration. Published 2023 by John Wiley & Sons Ltd.
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This chapter reCochrane Handbook for Systematic Reviews of Interventions to ensure consistency in
guidance for authors of Cochrane Reviews.
Li T, Higgins JPT, Deeks JJ (editors). Chapter 5: Collecting data. In: Higgins JPT,
Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane
Handbook for Systematic Reviews of Interventions version 6.1 (updated September
2020). Cochrane, 2020.
uses and builds on material included in the following chapter of the
7.1 Introduction
The findings of a systematic review depend critically on decisions relating to which data
from the included studies are presented and analysed. Data collected for systematic
reviews should be accurate, complete and accessible for future updates of the review
and for data sharing. Methods used for these decisions should be transparent; they should
be chosen to minimize biases and human error. This chapter describes approaches that
should be used in systematic reviews of test accuracy for collecting data, including
extraction of data directly from journal articles and other study reports.
7.2 Sources ofdata
Journal articles are the source of the majority of data included in systematic reviews of
test accuracy (Korevaar 2020). They are relatively easy to identify, provide useful information about study methods and results, and data can be extracted quickly. A study
can be reported in multiple journal articles, each selecting different subgroups of the
population or reporting the results of different tests or testing thresholds. It is therefore
important to link together multiple reports of the same study.
Preprints and online publications are early versions of articles that may subsequently be accepted and published in journals. These publications may be found in open
access repositories, such as medRxiv or F1000, or in preprint repositories belonging to a
journal or scientific publisher. The status of these publications varies from first drafts, to
yet to be peermeans that data quality varies and that versions may follow each other quickly. Preprints
therefore may require extra checks to ensure that the extracted data are accurate, and
subsequent checking when final peer- reviewed publications are available.
Conference abstracts are commonly available and can provide a means of identifying unpublished studies. However, they provide limited information on study methods
and can be highly variable in reliability, accuracy and level of detail (Li 2017).
Errata and letters can be important sources of information about studies, including
critical weaknesses and retractions, and review authors should examine these if
they are identified. Letters may also report additional test accuracy data from the
correspondents’ own institution, for example in response to a primary study previously
published in the same journal. Furthermore, some journals publish short reports of
studies as a research letter.
reviewed final drafts, to peer- reviewed pre- publication versions. This
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Trials registers (e.g. ClinicalTrials.gov) catalogue trials that have been planned,
started or completed, and have become an important data source for identifying trials,
for comparing published outcomes and results with those planned, and for obtaining
efficacy and safety data that are not available elsewhere. Trials registers can also
includerecords for test accuracy studies, although most are not registered before their
initiation (Korevaar 2014, Korevaar 2017).
Clinical study reports (CSRs) contain unabridged and comprehensive descriptions
of the clinical problem, design, conduct and results of clinical trials, following a structure and content guidance prescribed by the International Conference on Harmonisation
(ICH 1995). CSRs must be submitted by pharmaceutical companies to regulatory
authorities in order to obtain marketing approval of drugs and biologics for a specific
indication. CSRs are less likely to exist or will be difficult to obtain for the majority of
medical tests or devices, as the same detailed documentation is not required by regulators as for drug trials. Manufacturers of invitro diagnostics (IVDs) often provide some
information on clinical performance characteristics in the package inserts or ‘instructions for use’ for tests. Limited detail is usually reported in regard to study methods and
participant characteristics. Caution should be taken to clearly identify the source of such
data if used in a systematic review.
Regulatory reviews such as those available from the US Food and Drug Administration,
the World Health Organization (WHO), the European Medicines Agency, Centers for
Disease Control and Prevention or independent public health organizations such as
national reference laboratories may provide useful information about general medical
devices (including software-
based devices) and IVD medical devices that has been submitted by manufacturers for marketing approval (www.fda.gov/medical- devices/ivdregulatory- assistance/overview- ivd- regulation). These documents are summaries of
submitted evidence, prepared by agency staff as part of the process of approving the
products for marketing. In the EU the evidence required to be submitted in support of a
device varies according to the device class or perceived risk. For most tests, there is no
minimum performance standard.
Individual participant data (IPD) are usually sought directly from the researchers
responsible for the study, or may be identified from open data repositories (e.g. www.
clinicalstudydatarequest.com). Access to IPD has the advantage of allowing review
authors to reanalyse the data flexibly, in accordance with the preferred analysis methods outlined in the protocol, and can reduce the variation in analysis methods across
studies included in the review (Riley 2008, Stewart 2015). Although IPD analyses for systematic reviews of test accuracy are available (e.g. Hooper 2015), they are less common
than for intervention reviews.
7.2.1 Studies (not reports) asthe unit ofinterest
In a systematic review, studies rather than reports of studies are the principal unit of
interest. Often, data for series of participants from an individual institution, or who
were recruited to a particular study, are published multiple times with slight differences in periods of recruitment or eligibility criteria and limited cross- referencing
between study reports. Since a study may have been reported in several sources,
acomprehensive search for studies for the review may identify several reports from
apotentially relevant study (Mayo- Wilson 2017a, Mayo- Wilson 2018). Conversely, a report
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7 Collecting data
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(e.g. Smith 2020) may describe more than one study, in which case several study identifiers (e.g. Smith 2020a and Smith 2020b) may need to be created to uniquely identify
them in the review, with a separate data extraction completed for each. Similarly, a
report may separately describe data for participants from more than one centre. If
there is a suspicion of systematic differences in participants between centres despite
the use of the same eligibility criteria (e.g. due to endemicity of infection, or centre
specialization affecting the underlying spectrum of participants between centres),
then review authors may choose to consider data from each centre as a separate
‘study’ in the review. The extraction of data from multiple reports of the same study is
considered further in Section7.5.4.
Multiple reports of the same study should be linked together. Some review authors
prefer to link reports before they collect data and collect data from across the reports
onto a single form. Other review authors prefer to collect data from each report and then
link together the collected data across reports. Either strategy may be appropriate,
depending on the nature of the reports. It may not be clear that two reports relate to the
same study until data collection has commenced. Although sometimes there is a single
report for each study, it should never be assumed that this is the case.
It can be difficult to link multiple reports from the same study, and review authors
may need to do some ‘detective work’. Multiple sources about the same study may not
reference each other, may not share common authors (Gøtzsche1989, Tramèr 1997) or
report discrepant information about the study design, characteristics and results
(vonElm 2004, Mayo-
Wilson 2017a).
Some of the most useful criteria for linking reports are:
●
authors’ names;
●
study location and setting (particularly if institutions, such as hospitals, are named);
●
date and duration of the study (which also can clarify whether different sample sizes
are due to different periods of recruitment), length of follow- up or subgroups selected
to address secondary objectives;
●
numbers of participants and participant characteristics; and
●
specific details of the tests, thresholds and timing of tests.
Other criteria to consider include:
●
sponsor for the study and sponsor identifiers (e.g. grant or contract numbers); and
●
study registration numbers.
Review authors should use as many study characteristics as possible to link multiple
reports. When uncertainties remain after considering these and other factors, it may be
necessary to correspond with the study authors or sponsors for confirmation.
7.2.2 Correspondence withinvestigators
Review authors often find that they are unable to obtain all the information they seek
from available reports about the details of the study design, eligibility criteria, index
tests or reference standards, or key pieces of data needed to construct 2×2 contingency
tables may be missing. Missing information frequently affects review authors’ assessments
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