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International Journal of Surgery 8 (2010) 336e341

Contents lists available at ScienceDirect

International Journal of Surgery


journal homepage: www.theijs.com

Preferred reporting items for systematic reviews and meta-analyses:


The PRISMA statement
David Moher a, b, *, Alessandro Liberati c, d, Jennifer Tetzlaff a, Douglas G. Altmane, The PRISMA Groupf
a
Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
b
Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
c
Università di Modena e Reggio Emilia, Modena, Italy
d
Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri, Milan, Italy
e
Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom

a r t i c l e i n f o

Article history:
Available online 18 February 2010

Keywords:
Reporting guidelines
Systematic reviews
Meta-analyses
Evaluating health interventions
Improving quality

1. Introduction six domains. Reporting was generally poor; between one and 14
characteristics were adequately reported (mean ¼ 7.7; standard
Systematic reviews and meta-analyses have become deviation ¼ 2.7). A 1996 update of this study found little
increasingly important in health care. Clinicians read them to improvement.7
keep up to date with their field,1,2 and they are often used as In 1996, to address the suboptimal reporting of meta-analyses,
a starting point for developing clinical practice guidelines. an international group developed a guidance called the QUOROM
Granting agencies may require a systematic review to ensure Statement (quality of reporting of meta-analyses), which focused
there is justification for further research,3 and some health care on the reporting of meta-analyses of randomized controlled trials.8
journals are moving in this direction.4 As with all research, the In this article, we summarize a revision of these guidelines,
value of a systematic review depends on what was done, what renamed PRISMA (preferred reporting items for systematic reviews
was found, and the clarity of reporting. As with other publica- and meta-analyses), which have been updated to address several
tions, the reporting quality of systematic reviews varies, limiting conceptual and practical advances in the science of systematic
readers’ ability to assess the strengths and weaknesses of those reviews (Box 1).
reviews.
Several early studies evaluated the quality of review reports. In
1987, Mulrow examined 50 review articles published in four 2. Terminology
leading medical journals in 1985 and 1986 and found that none
met all eight explicit scientific criteria, such as a quality assess- The terminology used to describe a systematic review and meta-
ment of included studies.5 In 1987, Sacks et al.6 evaluated the analysis has evolved over time. One reason for changing the name
adequacy of reporting of 83 meta-analyses on 23 characteristics in from QUOROM to PRISMA was the desire to encompass both
systematic reviews and meta-analyses. We have adopted the defi-
nitions used by the Cochrane Collaboration.9 A systematic review is
a review of a clearly formulated question that uses systematic and
Abbreviations: PRISMA, preferred reporting items for systematic reviews and explicit methods to identify, select, and critically appraise relevant
meta-analyses; QUOROM, quality of reporting of meta-analyses research, and to collect and analyze data from the studies that are
* Corresponding author. Ottawa Methods Centre, Ottawa Hospital Research
Institute, Ottawa, Ontario, Canada.
included in the review. Statistical methods (meta-analysis) may or
E-mail address: [email protected] (D. Moher). may not be used to analyze and summarize the results of the
f
Membership of the PRISMA Group is provided in the Acknowledgments. included studies. Meta-analysis refers to the use of statistical

1743-9191/$ e see front matter Ó 2010 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.ijsu.2010.02.007
D. Moher et al. / International Journal of Surgery 8 (2010) 336e341 337

clinicians, medical editors, and a consumer. The objective of the


Box 1. Conceptual issues in the evolution from QUOROM to Ottawa meeting was to revise and expand the QUOROM checklist
PRISMA and flow diagram, as needed.
The executive committee completed the following tasks, prior to
Completing a systematic review is an iterative process the meeting: a systematic review of studies examining the quality of
The conduct of a systematic review depends heavily on reporting of systematic reviews, and a comprehensive literature
the scope and quality of included studies: thus systematic
search to identify methodological and other articles that might
reviewers may need to modify their original review
inform the meeting, especially in relation to modifying checklist
protocol during its conduct. Any systematic review
reporting guideline should recommend that such items. An international survey of review authors, consumers, and
changes can be reported and explained without sug- groups commissioning or using systematic reviews and meta-
gesting that they are inappropriate. The PRISMA State- analyses was completed, including the International Network of
ment (Items 5, 11, 16, and 23) acknowledges this iterative Agencies for Health Technology Assessment (INAHTA) and the
process. Aside from Cochrane reviews, all of which Guidelines International Network (GIN). The survey aimed to
should have a protocol, only about 10% of systematic ascertain views of QUOROM, including the merits of the existing
reviewers report working from a protocol.22 Without checklist items. The results of these activities were presented during
a protocol that is publicly accessible, it is difficult to judge the meeting and are summarized on the PRISMA Web site (http://
between appropriate and inappropriate modifications.
www.prisma-statement.org/).
Only items deemed essential were retained or added to the
Conduct and reporting research are distinct concepts
This distinction is, however, less straightforward for checklist. Some additional items are nevertheless desirable, and
systematic reviews than for assessments of the report- review authors should include these, if relevant.10 For example, it is
ing of an individual study, because the reporting and useful to indicate whether the systematic review is an update11 of
conduct of systematic reviews are, by nature, closely a previous review, and to describe any changes in procedures from
intertwined. For example, the failure of a systematic those described in the original protocol.
review to report the assessment of the risk of bias in Shortly after the meeting a draft of the PRISMA checklist was
included studies may be seen as a marker of poor circulated to the group, including those invited to the meeting but
conduct, given the importance of this activity in the unable to attend. A disposition file was created containing comments
systematic review process.37
and revisions from each respondent, and the checklist was subse-
quently revised 11 times. The group approved the checklist, flow
Study-level versus outcome-level assessment of risk of bias
diagram, and this summary paper.
For studies included in a systematic review, a thorough
assessment of the risk of bias requires both a “study- Although no direct evidence was found to support retaining or
level” assessment (e.g., adequacy of allocation conceal- adding some items, evidence from other domains was believed to
ment) and, for some features, a newer approach called be relevant. For example, Item 5 asks authors to provide regis-
“outcome-level” assessment. An outcome-level assess- tration information about the systematic review, including
ment involves evaluating the reliability and validity of the a registration number, if available. Although systematic review
data for each important outcome by determining the registration is not yet widely available,12,13 the participating
methods used to assess them in each individual study.38 journals of the International Committee of Medical Journal Editors
The quality of evidence may differ across outcomes, even (ICMJE)14 now require all clinical trials to be registered in an effort
within a study, such as between a primary efficacy
to increase transparency and accountability.15 Those aspects are
outcome, which is likely to be very carefully and
systematically measured, and the assessment of serious also likely to benefit systematic reviewers, possibly reducing the
harms,39 which may rely on spontaneous reports by risk of an excessive number of reviews addressing the same
investigators. This information should be reported to question16,17 and providing greater transparency when updating
allow an explicit assessment of the extent to which an systematic reviews.
estimate of effect is correct.38
4. The PRISMA statement
Importance of reporting biases
Different types of reporting biases may hamper the The PRISMA Statement consists of a 27-item checklist (Table 1)
conduct and interpretation of systematic reviews. Selec- and a four-phase flow diagram (Fig. 1). The aim of the PRISMA
tive reporting of complete studies (e.g., publication bias)28
Statement is to help authors improve the reporting of systematic
as well as the more recently empirically demonstrated
reviews and meta-analyses. We have focused on randomized trials,
“outcome reporting bias” within individual studies40,41
should be considered by authors when conducting but PRISMA can also be used as a basis for reporting systematic
a systematic review and reporting its results. Though the reviews of other types of research, particularly evaluations of inter-
implications of these biases on the conduct and reporting ventions. PRISMA may also be useful for critical appraisal of published
of systematic reviews themselves are unclear, some systematic reviews. However, the PRISMA checklist is not a quality
previous research has identified that selective outcome assessment instrument to gauge the quality of a systematic review.
reporting may occur also in the context of systematic
reviews.42 5. From QUOROM to PRISMA

The new PRISMA checklist differs in several respects from the


techniques in a systematic review to integrate the results of QUOROM checklist, and the substantive specific changes are
included studies. highlighted in Table 2. Generally, the PRISMA checklist “decouples”
several items present in the QUOROM checklist and, where appli-
3. Developing the PRISMA statement cable, several checklist items are linked to improve consistency
across the systematic review report.
A three-day meeting was held in Ottawa, Canada, in June 2005 The flow diagram has also been modified. Before including
with 29 participants, including review authors, methodologists, studies and providing reasons for excluding others, the review
338 D. Moher et al. / International Journal of Surgery 8 (2010) 336e341

Table 1
Checklist of items to include when reporting a systematic review (with or without meta-analysis).

Section/topic # Checklist item Reported on Page #


Title
Title 1 Identify the report as a systematic review, meta-analysis, or both.
Abstract
Structured summary 2 Provide a structured summary including, as applicable: background; objectives; data sources;
study eligibility criteria, participants, and interventions; study appraisal and synthesis methods;
results; limitations; conclusions and implications of key findings;
systematic review registration number.
Introduction
Rationale 3 Describe the rationale for the review in the context of what is already known.
Objectives 4 Provide an explicit statement of questions being addressed with reference to participants,
interventions, comparisons, outcomes, and study design (PICOS).
Methods
Protocol and registration 5 Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address),
and, if available, provide registration information including registration number.
Eligibility criteria 6 Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics
(e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale.
Information sources 7 Describe all information sources (e.g., databases with dates of coverage, contact with study
authors to identify additional studies) in the search and date last searched.
Search 8 Present full electronic search strategy for at least one database, including any limits used,
such that it could be repeated.
Study selection 9 State the process for selecting studies (i.e., screening, eligibility, included in systematic review,
and, if applicable, included in the meta-analysis).
Data collection 10 Describe method of data extraction from reports (e.g., piloted forms, independently,
process in duplicate) and any processes for obtaining and confirming data from investigators.
Data items 11 List and define all variables for which data were sought (e.g., PICOS, funding sources)
and any assumptions and simplifications made.
Risk of bias in individual 12 Describe methods used for assessing risk of bias of individual studies (including
studies specification of whether this was done at the study or outcome level), and how
this information is to be used in any data synthesis.
Summary measures 13 State the principal summary measures (e.g., risk ratio, difference in means).
Synthesis of results 14 Describe the methods of handling data and combining results of studies, if done,
including measures of consistency (e.g., I2) for each meta-analysis.
Risk of bias 15 Specify any assessment of risk of bias that may affect the cumulative evidence
across studies (e.g., publication bias, selective reporting within studies).
Additional analyses 16 Describe methods of additional analyses (e.g., sensitivity or subgroup analyses,
meta-regression), if done, indicating which were pre-specified.
Results
Study selection 17 Give numbers of studies screened, assessed for eligibility, and included in the review,
with reasons for exclusions at each stage, ideally with a flow diagram.
Study characteristics 18 For each study, present characteristics for which data were extracted (e.g., study size,
PICOS, follow-up period) and provide the citations.
Risk of bias within studies 19 Present data on risk of bias of each study and, if available,
any outcome-level assessment (see Item 12).
Results of individual 20 For all outcomes considered (benefits or harms), present, for each study:
studies (a) simple summary data for each intervention group and
(b) effect estimates and confidence intervals, ideally with a forest plot.
Synthesis of results 21 Present results of each meta-analysis done, including confidence
intervals and measures of consistency.
Risk of bias across 22 Present results of any assessment of risk of bias across studies (see Item 15).
studies
Additional analysis 23 Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression).
Discussion
Summary of evidence 24 Summarize the main findings including the strength of evidence for each main outcome;
consider their relevance to key groups (e.g., health care providers, users, and policy makers).
Limitations 25 Discuss limitations at study and outcome level (e.g., risk of bias), and at review level
(e.g., incomplete retrieval of identified research, reporting bias).
Conclusions 26 Provide a general interpretation of the results in the context of other evidence,
and implications for future research.
Funding
Funding 27 Describe sources of funding for the systematic review and other support
(e.g., supply of data); role of funders for the systematic review.

team must first search the literature. This search results in 6. Endorsement
records. Once these records have been screened and eligibility
criteria applied, a smaller number of articles will remain. The The PRISMA Statement should replace the QUOROM Statement
number of included articles might be smaller (or larger) than the for those journals that have endorsed QUOROM. We hope that
number of studies, because articles may report on multiple other journals will support PRISMA; they can do so by registering
studies and results from a particular study may be published in on the PRISMA Web site. To underscore to authors, and others, the
several articles. To capture this information, the PRISMA flow importance of transparent reporting of systematic reviews, we
diagram now requests information on these phases of the review encourage supporting journals to reference the PRISMA Statement
process. and include the PRISMA Web address in their Instructions to
D. Moher et al. / International Journal of Surgery 8 (2010) 336e341 339

8. Discussion

The quality of reporting of systematic reviews is still not


optimal.22e27 In a recent review of 300 systematic reviews, few
authors reported assessing possible publication bias,22 even
though there is overwhelming evidence both for its existence28
and its impact on the results of systematic reviews.29 Even
when the possibility of publication bias is assessed, there is no
guarantee that systematic reviewers have assessed or interpreted
it appropriately.30 Although the absence of reporting such an
assessment does not necessarily indicate that it was not done,
reporting an assessment of possible publication bias is likely to be
a marker of the thoroughness of the conduct of the systematic
review.
Several approaches have been developed to conduct systematic
reviews on a broader array of questions. For example, systematic
reviews are now conducted to investigate cost-effectiveness,31
diagnostic32 or prognostic questions,33 genetic associations,34 and
policy making.35 The general concepts and topics covered by
PRISMA are all relevant to any systematic review, not just those
Fig. 1. Flow of information through the different phases of a systematic review. whose objective is to summarize the benefits and harms of a health
care intervention. However, some modifications of the checklist
Authors. We also invite editorial organizations to consider items or flow diagram will be necessary in particular circumstances.
endorsing PRISMA and encourage authors to adhere to its For example, assessing the risk of bias is a key concept, but the
principles. items used to assess this in a diagnostic review are likely to focus on
issues such as the spectrum of patients and the verification of
7. The PRISMA explanation and elaboration paper disease status, which differ from reviews of interventions. The flow
diagram will also need adjustments when reporting individual
In addition to the PRISMA statement, a supporting explana- patient data meta-analysis.36
tion and elaboration document has been produced18 following We have developed an explanatory document18 to increase the
the style used for other reporting guidelines.19e21 The process of usefulness of PRISMA. For each checklist item, this document
completing this document included developing a large database contains an example of good reporting, a rationale for its inclusion,
of exemplars to highlight how best to report each checklist item, and supporting evidence, including references, whenever possible.
and identifying a comprehensive evidence base to support the We believe this document will also serve as a useful resource for
inclusion of each checklist item. The explanation and elabora- those teaching systematic review methodology. We encourage
tion document was completed after several face to face meet- journals to include reference to the explanatory document in their
ings and numerous iterations among several meeting Instructions to Authors.
participants, after which it was shared with the whole group for Like any evidence-based endeavor, PRISMA is a living document.
additional revisions and final approval. Finally, the group To this end we invite readers to comment on the revised version,
formed a dissemination subcommittee to help disseminate and particularly the new checklist and flow diagram, through the
implement PRISMA.

Table 2
Substantive specific changes between the QUOROM checklist and the PRISMA checklist (a tick indicates the presence of the topic in QUOROM or PRISMA).

Section/topic Item QUOROM PRISMA Comment


Abstract O O QUOROM and PRISMA ask authors to report an abstract. However,
PRISMA is not specific about format.
Introduction Objective O This new item (4) addresses the explicit question the review addresses
using the PICO reporting system (which describes the participants,
interventions, comparisons, and outcome(s) of the systematic review),
together with the specification of the type of study design (PICOS);
the item is linked to Items 6, 11, and 18 of the checklist.
Methods Protocol O This new item (5) asks authors to report whether the review has a
protocol and if so how it can be accessed.
Methods Search O O Although reporting the search is present in both QUOROM and PRISMA checklists,
PRISMA asks authors to provide a full description of at least one electronic search
strategy (Item 8). Without such information it is impossible to repeat the authors’ search.
Methods Assessment of risk of O O Renamed from “quality assessment” in QUOROM. This item (12) is linked
bias in included studies with reporting this information in the results (Item 19). The new concept
of “outcome-level” assessment has been introduced.
Methods Assessment of bias O This new item (15) asks authors to describe any assessments of bias in the review,
across studies such as selective reporting within the included studies. This item is linked with
reporting this information in the results (Item 22).
Discussion O O Although both QUOROM and PRISMA checklists address the discussion section,
PRISMA devotes three items (24e26) to the discussion. In PRISMA the main types
of limitations are explicitly stated and their discussion required.
Funding O This new item (27) asks authors to provide information on any sources
of funding for the systematic review.
340 D. Moher et al. / International Journal of Surgery 8 (2010) 336e341

PRISMA Web site. We will use such information to inform PRISMA’s Norway); Ba’ Pham, MMath, Toronto Health Economics and
continued development. Technology Assessment Collaborative (Toronto, Canada) (at the
time of the first meeting of the group, GlaxoSmithKline Canada,
Author contributions Mississauga, Canada); Drummond Rennie, MD, FRCP, FACP,
University of California San Francisco (San Francisco, California,
ICMJE criteria for authorship read and met: DM AL JT DGA. US); Margaret Sampson, MLIS, Children’s Hospital of Eastern
Wrote the first draft of the paper: DM AL DGA. Contributed to Ontario (Ottawa, Canada); Kenneth F. Schulz, PhD, MBA, Family
the writing of the paper: DM AL JT DGA. Participated in regular Health International (Durham, North Carolina, US); Paul G. Shek-
conference calls, identified the participants, secured funds, elle, MD, PhD, Southern California Evidence Based Practice Center
planned the meeting, participated in the meeting, and drafted (Santa Monica, California, US); Jennifer Tetzlaff, BSc, Ottawa
the manuscript: DM AL DGA. Participated in identifying the Methods Centre, Ottawa Hospital Research Institute (Ottawa,
evidence base for PRISMA, refining the checklist, and drafting Canada); David Tovey, FRCGP, The Cochrane Library, Cochrane
the manuscript: JT. Agree with the recommendations: DM AL JT Collaboration (Oxford, UK) (at the time of the first meeting of the
DGA. group, BMJ, London, UK); Peter Tugwell, MD, MSc, FRCPC, Institute
of Population Health, University of Ottawa (Ottawa, Canada).
Acknowledgments
Funding
The following people contributed to the PRISMA Statement: PRISMA was funded by the Canadian Institutes of Health Research;
Doug Altman, DSc, Centre for Statistics in Medicine (Oxford, UK); Universita` di Modena e Reggio Emilia, Italy; Cancer Research UK;
Gerd Antes, PhD, University Hospital Freiburg (Freiburg, Clinical Evidence BMJ Knowledge; the Cochrane Collaboration; and
Germany); David Atkins, MD, MPH, Health Services Research and GlaxoSmithKline, Canada. AL is funded, in part, through grants of
Development Service, Veterans Health Administration (Wash- the Italian Ministry of University (COFIN - PRIN2002 prot.
ington, D. C., US); Virginia Barbour, MRCP, DPhil, PLoS Medicine 2002061749 and COFIN - PRIN 2006 prot. 2006062298). DGA is
(Cambridge, UK); Nick Barrowman, PhD, Children’s Hospital of funded by Cancer Research UK. DM is funded by a University of
Eastern Ontario (Ottawa, Canada); Jesse A. Berlin, ScD, Johnson & Ottawa Research Chair. None of the sponsors had any involvement
Johnson Pharmaceutical Research and Development (Titusville, in the planning, execution, or write-up of the PRISMA documents.
New Jersey, US); Jocalyn Clark, PhD, PLoS Medicine (at the time of Additionally, no funder played a role in drafting the manuscript.
writing, BMJ, London, UK); Mike Clarke, PhD, UK Cochrane Centre
Competing interests
(Oxford, UK) and School of Nursing and Midwifery, Trinity College
The authors have declared that no competing interests exist.
(Dublin, Ireland); Deborah Cook, MD, Departments of Medicine,
Clinical Epidemiology and Biostatistics, McMaster University
(Hamilton, Canada); Roberto D’Amico, PhD, Università di Modena
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