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Individual Participant Data
Individual Participant Data
data
Jayne F Tierney, Lesley A Stewart, Mike Clarke; on behalf of the Cochrane Individual
Participant Data Meta-analysis Methods Group
Key Points:
• Individual participant data (IPD) reviews are a specific type of systematic review that
involve the collection, checking and re-analysis of the original data for each participant
in each study. Data may be obtained either from study investigators or via data-sharing
repositories or platforms.
• IPD reviews should be considered when the available published or other aggregate data
do not permit a good quality review, or are insufficient for a thorough analysis. In certain
situations, aggregate data synthesis might be an appropriate first step.
• The IPD approach can bring substantial improvements to the quality of data available
and offset inadequate reporting of individual studies. Risk of bias can be assessed more
thoroughly and IPD enables more detailed and flexible analysis than is possible in
systematic reviews of aggregate data.
• Access to IPD offers scope to analyse data and report results in many different ways, so
analytical methods should be pre-specified in detail and reporting should follow the
PRISMA-IPD guideline.
• Most commonly, IPD reviews are carried out by a collaborative group, comprising a
project management team, the researchers who contribute their study data, and an
advisory group.
• An IPD review usually takes longer and costs more than a conventional systematic
review of the same question, and requires a range of skills to obtain, manage and
analyse data. Thus, they are difficult to do without dedicated time and funding.
This chapter should be cited as: Tierney JF, Stewart LA, Clarke M. Chapter 26: Individual
participant 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 6.3
(updated February 2022). Cochrane, 2022. Available from
www.training.cochrane.org/handbook.
26.1 Introduction
26.1.1 What is an IPD review?
Systematic reviews incorporating individual participant data (IPD) include the original data
from each eligible study. The IPD will usually contain de-identified demographic
information for each participant such as age, sex, nature of their health condition, as well as
information about treatments or tests received and outcomes observed (Stewart et al 1995,
Stewart and Tierney 2002). These data can then be checked and analysed centrally and, if
appropriate, combined in meta-analyses (Stewart et al 1995, Stewart and Tierney 2002).
Most commonly, IPD are sought directly from the study investigators, but access through
data-sharing platforms and data repositories may increase in the coming years.
Advantages of an IPD approach are summarized in Table 26.1.a. Compared with aggregate
data, the collection of IPD can bring about substantial improvements to the quantity and
quality of data, for example, through the inclusion of more trials, participants and outcomes
(Debray et al 2015a, Tierney et al 2015a). A Cochrane Methodology Review of empirical
research shows some of these advantages (Tudur Smith et al 2016). IPD also affords greater
scope and flexibility in the analyses, including the ability to investigate how participant-
level covariates such as age or severity of disease might alter the impact of the treatment,
exposure or test under investigation (Debray et al 2015a, Debray et al 2015b, Tierney et al
2015a). With such better-quality data and analysis, IPD reviews can help to provide in-depth
explorations and robust meta-analysis results, which may differ from those based on
aggregate data (Tudur Smith et al 2016). Not surprisingly then, IPD reviews have had a
substantial impact on clinical practice and research, but could be better used to inform
treatment guidelines (Vale et al 2015), and new studies (Tierney et al 2015b). However, IPD
reviews can take longer than other reviews; those evaluating the effects of therapeutic
interventions typically taking at least two years to complete. Also, they usually require a
skilled team with dedicated time and specific funding.
This chapter provides an overview of the IPD approach to systematic reviews, to help
authors decide whether collecting IPD might be useful and feasible for their review. As most
IPD reviews have assessed the efficacy of interventions, and have been based on
randomized trials, this is the focus of the chapter. However, the approach also offers
particular advantages for the synthesis of diagnostic and prognostic studies (Debray et al
2015a) and many of the principles described will apply to these sorts of synthesis. The
chapter does not provide detailed guidance on practical or statistical methods, which are
summarized elsewhere (Stewart et al 1995, Stewart and Tierney 2002, Debray et al 2015b,
Tierney et al 2015a). Therefore, anyone contemplating carrying out their first IPD meta-
analysis as part of a Cochrane Review should seek appropriate advice and guidance from
experienced researchers through the IPD Meta-analysis Methods Group.
Table 26.1.a Advantages of the IPD approach to systematic review and meta-analysis.
Adapted from (Tierney et al 2015a) (licensed under CC BY 4.0).
Study inclusion Asking the IPD collaborative group (of study investigators and
other experts in the clinical field) to supplement list of identified
studies.*
Data quality Include studies that are unpublished or not reported in full.
Check the integrity of study IPD and resolve any queries with
investigators.
Risk of bias Clarify study design, conduct and analysis methods with trial
investigators.*
Check risk of bias of study IPD and obtain extra data where
necessary.
Account for missing data at the patient level (e.g. using multiple
imputation). Use IPD to address secondary clinical questions
(e.g. to explore the natural history of disease, prognostic factors
or surrogate outcomes).
Involving the investigators responsible for the primary studies can highlight additional
eligible studies done by or known to them, and help to clarify the design and conduct of
included studies, thereby improving the reliability of risk of bias assessments (Vale et al
2013). Moreover, the ability to directly check IPD and seek additional data may alleviate
some of the biases associated with aggregate data reviews (Stewart et al 2005).
The project should culminate in the preparation and dissemination of a structured report,
following PRISMA-IPD (Stewart et al 2015) where possible. This is a stand-alone extension to
PRISMA that is geared to the IPD approach and, while it focuses on reviews of efficacy, many
elements are applicable to other types of IPD review.
Systematic reviews based on IPD require expertise in data management and statistical
analysis, as well as skills in managing research collaborations, and they often take longer
and require more resource than a conventional aggregate data systematic review of the
same question. Therefore, IPD reviews are difficult to conduct in review authors’ ‘spare
time’, and are likely to require dedicated resources and staff.
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Often, the research team convenes a meeting of all collaborators to present and discuss
preliminary results, and can draw on these discussions when drafting manuscripts. Results
are usually published in the name of the collaborative group, with all collaborators being
listed as co-authors of the review publication, and all contributions and conflicts should be
clearly described therein.
Another important consideration is whether sufficient IPD are likely to be available to permit
credible analysis. For example, some study data may have been destroyed or lost, some
outcomes, such as adverse effects or quality of life may not have been collected
systematically for all studies, or study investigators may not wish to collaborate (although
this may not be known at the outset). Also, it may not be possible to complete an IPD review
in a suitable time frame for the question of interest and, in some situations, the additional
Copyright © 2022 The Cochrane Collaboration
resource required may be prohibitive. Weighing up these various factors will help determine
when the IPD approach is likely to bring most benefit.
Before embarking on an IPD review, review authors need to think carefully about which
skills and resources will be required for the project to succeed, and seek advice and training.
The Cochrane IPD Meta-analysis Methods Group is a good first point of contact.
26.2.2 Obtaining data from sources other than the original researchers
A number of initiatives are helping to increase the availability of IPD from both academic
and industry-led studies, either through generic data sharing platforms such as Yale Open
Data, Clinical Study Data Request, DataSphere or Vivli. These have been in response to calls
from federal agencies (e.g. NIH), funders (e.g. MRC), journal editors, the AllTrials campaign
and Cochrane to make results and IPD from clinical studies more readily available.
As the focus of these efforts is to make the data from individual studies available, formatting
and coding are not necessarily standard or consistent across the different study datasets.
Some platforms offer fully unrestricted access to IPD and others moderated access, with
release subject to approval of a project proposal. Also, while some sources allow transfer of
IPD directly to the research team conducting the review, others limit the use of IPD to within
Copyright © 2022 The Cochrane Collaboration
a secure area within a platform. Therefore, for any given review, the availability of study IPD
from these platforms may be patchy, the modes of access variable, and the usual process of
re-formatting and re-coding data in a consistent way will likely be required. Thus, although
promising, as yet they do not provide a viable alternative to the traditional collaborative IPD
approach. As the culture of data sharing gathers pace, the increased availability and
accessibility of IPD should benefit the production of IPD reviews.
For instance, since 1985, the Early Breast Cancer Trialists’ Collaborative Group has amassed
the majority of trials in early breast cancer and collected extended follow-up, in order to
evaluate the effects of all the key interventions in the long term
(http://gas.ndph.ox.ac.uk/ebctcg). For example, they have shown that women with
oestrogen-receptor positive breast cancer still face a substantial risk of cancer recurrence
more than 20 years after their endocrine treatment (Pan et al 2017). The ACCENT repository
built on existing colorectal cancer IPD reviews has been used to identify disease-free
survival as a surrogate for overall survival (Sargent et al 2007), and show the prognostic
impact of baseline body mass index on survival (Sinicrope et al 2013), and a network meta-
analysis of multiple IPD reviews of drug monotherapy for epilepsy, shows the most suitable
first-line treatments for partial onset and generalized tonic-clonic seizures (Nevitt et al
2017).
A considerable advantage of such repositories is that data items can be coded to a common
format from the outset, facilitating subsequent re-use of data, and the IPD can be checked
by those with topic expertise. The benefits of working with study investigators are also
retained. Of course, the retention and re-use of IPD should comply with the same data
security and confidentiality measures as for the original review, and new ethics approval
and data use agreements should be sought if required. It is vitally important that any new
analyses follow a new pre-specified protocol and/or analysis plan.
remove or redact free-text verbatim terms, and remove explicit information on the dates of
events. Note that full anonymization, whereby all links between the de-identified datasets
and the original datasets are destroyed, limits the utility of IPD for systematic reviews and
therefore is not recommended. All participant data should be transferred via a secure data
transfer site or by encrypted email.
Historically, ethical review was not sought for IPD reviews, on the premise that they were
addressing the same research question as the original studies for which participants already
gave their informed consent. However, evolving data protection regulations (e.g. the EU
General Data Protection Regulation) and changing attitudes to data sharing mean that, in
some circumstances, formal ethical approval will be required by the Institutes holding IPD
and be expected by those supplying data. This should be explored with the ethics
committee/board under whose jurisdiction the research team operate, and even if formal
review is not required, it may be useful to send written confirmation of this to those
providing data. It is perhaps more likely that ethical review will be required if review authors
are using IPD to address a different question from the original studies, or when seeking data
from a research study that was not subject to prior ethical review and did not obtain formal
patient consent, such as clinical audit data. This does not imply, however, that new consent
will need to be obtained from the participants in the original study; de-identification of data
usually means this is not necessary. Moreover, in many circumstances it would be difficult
or impossible to obtain consent retrospectively, for example in older studies (because
participants would be difficult to trace) or, in studies of life-limiting conditions (because
many participants will have died).
In addition, the aim should be to maximize the quality of the data and so enhance the
analyses. For example, data on all participants and outcomes included in studies should be
sought irrespective of whether they were part of the reported analyses. Thus, before
embarking on data collection, it is worthwhile checking the study protocols and/or with the
original researchers to determine which data are actually available. In many cases it will
only be necessary to collect outcomes and participant characteristics as defined in the
individual studies. However, additional variables might be required to provide greater
granularity (e.g. subscales in quality of life instruments), or to allow outcomes or other
variables to be defined in a consistent way for each study. For example, to redefine pre-
eclampsia according to a common definition, data on systolic and diastolic blood pressure
and proteinurea are needed (Askie et al 2007).
IPD provides the most practical way to synthesize data for time-to-event outcomes, such as
time to recovery, time free of seizures, or time to death. Therefore, it is important to collect
data on whether an event (e.g. death) has happened, the date of the event (e.g. date of
death) and the date of last follow-up for those not experiencing an event. As a bare
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minimum, whether an event happened and the time that each individual spent ‘event-free’
may suffice. IPD also allows follow-up to be updated sometimes substantially beyond the
point of publication (Stewart et al 1995, Stewart and Tierney 2002), which has been
particularly important in evaluating the long-term effects of therapies in the cancer field
(Pan et al 2017).
Also, the data supplied should be checked against any relevant study publications or results
repositories to highlight any inconsistencies in, for example, the distribution of baseline
characteristics, the number of participants and the outcome results. However, it should be
borne in mind that differences might arise because of continued enrolment or further
follow-up subsequent to publication.
For time-to-event outcomes, where events are observed over a prolonged period, for
example survival in cancer trials, it is important to also check that follow-up is sufficient and
balanced by randomized group. By requesting follow-up that is as up to date as possible,
and which may be substantially beyond the results reported in trial publications, transitory
effects can be avoided and any benefits or harms of interventions that take a long time to
accrue, such as late side effects of treatment or late recurrence of disease, can be picked up.
For example, in an IPD meta-analysis of chemotherapy for soft tissue sarcoma (Sarcoma
Copyright © 2022 The Cochrane Collaboration
Meta-analysis Collaboration 1997), the median follow-up for trials reporting it ranged from
16 to 64 months, but increased to between 74 and 204 months when updated IPD were
obtained (Stewart et al 2005).
As IPD offers the potential to analyse data in many different ways, it is particularly important
that all methods relating to analysis are pre-specified in detail in the review protocol or
analysis plan (Tierney et al 2015a) and are clearly reported in publications (Stewart et al
2015). This should include: outcomes and their definitions; methods for checking IPD and
assessing risk of bias of included studies; methods for evaluating treatments effects, risks
or test accuracy (including those for exploring variations by trial or patient characteristics)
and methods for quantifying and accounting for heterogeneity. Unplanned analyses can
still play an important role in explaining or adding to the results, but such exploratory
analyses should be justified and clearly reported as such.
Statistical methods for the analysis of IPD can be complex and are described in more detail
elsewhere (Debray et al 2015b). These methods are less well developed for prognostic or
diagnostic test accuracy reviews than for interventions reviews based on randomized trials,
so we outline some key principles for the re-analysis of IPD from randomized trials.
Copyright © 2022 The Cochrane Collaboration
conflates within and across-trial interactions, so is susceptible to bias and might best be
avoided (Fisher et al 2011, Fisher et al 2017). Alternatively, a one-stage approach can be
used, but to avoid bias, again care must be taken to distinguish within-study interactions
from any between-study interactions (Riley et al 2008, Fisher et al 2011).
Importantly, and irrespective of the analytical method, where multiple subgroups have
been investigated and/or subgroups effects lack biological plausibility, results should be
viewed with caution (Clarke and Halsey 2001). Where there is no particular evidence that
trial or participant characteristics impact on the results, emphasis should be placed on the
overall effects.
diagnosis (Debray et al 2015a). Therefore, guidance has been prepared to help researchers,
clinicians, patients, policy makers, funders and publishers understand, appraise and make
best use of IPD reviews of randomized trials (Tierney et al 2015a), and diagnostic and
prognostic modelling studies (Debray et al 2015a).
Funding: JFT and coordination of the IPD Meta-analysis Methods Group is funded by the UK
Medical Research Council (MC_UU_12023/24); Lesley A Stewart is funded by the University
of York and Mike Clarke is funded by Queen’s University Belfast.
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