The PRISMA Statement
The PRISMA Statement
The PRISMA Statement
of completing this document included developing a large database reviews are now conducted to investigate cost-effectiveness [31],
of exemplars to highlight how best to report each checklist item, diagnostic [32] or prognostic questions [33], genetic associations
and identifying a comprehensive evidence base to support the [34], and policy making [35]. The general concepts and topics
inclusion of each checklist item. The Explanation and Elaboration covered by PRISMA are all relevant to any systematic review, not
document was completed after several face to face meetings and just those whose objective is to summarize the benefits and harms
numerous iterations among several meeting participants, after of a health care intervention. However, some modifications of the
which it was shared with the whole group for additional revisions checklist items or flow diagram will be necessary in particular
and final approval. Finally, the group formed a dissemination circumstances. For example, assessing the risk of bias is a key
subcommittee to help disseminate and implement PRISMA. concept, but the 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 disease status, which differ from reviews of
Discussion
interventions. The flow diagram will also need adjustments when
The quality of reporting of systematic reviews is still not reporting individual patient data meta-analysis [36].
optimal [22–27]. In a recent review of 300 systematic reviews, We have developed an explanatory document [18] to increase
few authors reported assessing possible publication bias [22], the usefulness of PRISMA. For each checklist item, this document
even though there is overwhelming evidence both for its contains an example of good reporting, a rationale for its inclusion,
existence [28] and its impact on the results of systematic and supporting evidence, including references, whenever possible.
reviews [29]. Even when the possibility of publication bias is We believe this document will also serve as a useful resource for
assessed, there is no guarantee that systematic reviewers have those teaching systematic review methodology. We encourage
assessed or interpreted it appropriately [30]. Although the journals to include reference to the explanatory document in their
absence of reporting such an assessment does not necessarily Instructions to Authors.
indicate that it was not done, reporting an assessment of possible Like any evidence-based endeavor, PRISMA is a living
publication bias is likely to be a marker of the thoroughness of document. To this end we invite readers to comment on the
the conduct of the systematic review. revised version, particularly the new checklist and flow diagram,
Several approaches have been developed to conduct systematic through the PRISMA Web site. We will use such information to
reviews on a broader array of questions. For example, systematic inform PRISMA’s continued development.
Reported on
Section/Topic # Checklist Item 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 process 10 Describe method of data extraction from reports (e.g., piloted forms, independently, 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 specification of whether this was
studies 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 across studies 15 Specify any assessment of risk of bias that may affect the cumulative evidence (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 studies 20 For all outcomes considered (benefits or harms), present, for each study: (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 studies 22 Present results of any assessment of risk of bias across studies (see Item 15).
Additional analysis 23 Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]).
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.
doi:10.1371/journal.pmed.1000097.t001
Abstract ! ! QUOROM and PRISMA ask authors to report an abstract. However, PRISMA is not
specific about format.
Introduction Objective ! 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 ! This new item (5) asks authors to report whether the review has a protocol and if so
how it can be accessed.
Methods Search ! ! 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 ! ! Renamed from ‘‘quality assessment’’ in QUOROM. This item (12) is linked with
risk of bias in reporting this information in the results (Item 19). The new concept of ‘‘outcome-
included studies level’’ assessment has been introduced.
Methods Assessment of ! This new item (15) asks authors to describe any assessments of risk of bias in the
risk of bias across review, such as selective reporting within the included studies. This item is linked
studies with reporting this information in the results (Item 22).
Discussion ! ! Although both QUOROM and PRISMA checklists address the discussion section,
PRISMA devotes three items (24–26) to the discussion. In PRISMA the main types of
limitations are explicitly stated and their discussion required.
Funding ! This new item (27) asks authors to provide information on any sources of funding for
the systematic review.
doi:10.1371/journal.pmed.1000097.t002
Supporting Information School of Public Health (Baltimore, Maryland, US); Matthias Egger,
MD, Department of Social and Preventive Medicine, University of Bern
Figure S1 Flow of information through the different (Bern, Switzerland); Edzard Ernst, MD, PhD, FRCP, FRCP(Edin),
phases of a systematic review (downloadable template Peninsula Medical School (Exeter, UK); Peter C. Gøtzsche, MD, MSc,
document for researchers to re-use). The Nordic Cochrane Centre (Copenhagen, Denmark); Jeremy Grim-
shaw, MBChB, PhD, FRCFP, Ottawa Hospital Research Institute
Found at: doi:10.1371/journal.pmed.1000097.s001 (0.08 MB
(Ottawa, Canada); Gordon Guyatt, MD, Departments of Medicine,
DOC) Clinical Epidemiology and Biostatistics, McMaster University (Hamilton,
Text S1 Checklist of items to include when reporting a Canada); Julian Higgins, PhD, MRC Biostatistics Unit (Cambridge, UK);
systematic review or meta-analysis (downloadable tem- John P. A. Ioannidis, MD, University of Ioannina Campus (Ioannina,
Greece); Jos Kleijnen, MD, PhD, Kleijnen Systematic Reviews Ltd
plate document for researchers to re-use).
(York, UK) and School for Public Health and Primary Care (CAPHRI),
Found at: doi:10.1371/journal.pmed.1000097.s002 (0.04 MB University of Maastricht (Maastricht, Netherlands); Tom Lang, MA,
DOC) Tom Lang Communications and Training (Davis, California, US);
Alessandro Liberati, MD, Università di Modena e Reggio Emilia
Acknowledgments (Modena, Italy) and Centro Cochrane Italiano, Istituto Ricerche
Farmacologiche Mario Negri (Milan, Italy); Nicola Magrini, MD, NHS
The following people contributed to the PRISMA Statement: Doug Centre for the Evaluation of the Effectiveness of Health Care – CeVEAS
Altman, DSc, Centre for Statistics in Medicine (Oxford, UK); Gerd (Modena, Italy); David McNamee, PhD, The Lancet (London, UK);
Antes, PhD, University Hospital Freiburg (Freiburg, Germany); David Lorenzo Moja, MD, MSc, Centro Cochrane Italiano, Istituto Ricerche
Atkins, MD, MPH, Health Services Research and Development Service, Farmacologiche Mario Negri (Milan, Italy); David Moher, PhD, Ottawa
Veterans Health Administration (Washington, D. C., US); Virginia Methods Centre, Ottawa Hospital Research Institute (Ottawa, Canada);
Barbour, MRCP, DPhil, PLoS Medicine (Cambridge, UK); Nick Barrow- Cynthia Mulrow, MD, MSc, Annals of Internal Medicine (Philadelphia,
man, PhD, Children’s Hospital of Eastern Ontario (Ottawa, Canada); Pennsylvania, US); Maryann Napoli, Center for Medical Consumers
Jesse A. Berlin, ScD, Johnson & Johnson Pharmaceutical Research and (New York, New York, US); Andy Oxman, MD, Norwegian Health
Development (Titusville, New Jersey, US); Jocalyn Clark, PhD, PLoS Services Research Centre (Oslo, Norway); Ba’ Pham, MMath, Toronto
Medicine (at the time of writing, BMJ, London, UK); Mike Clarke, PhD, Health Economics and Technology Assessment Collaborative (Toronto,
UK Cochrane Centre (Oxford, UK) and School of Nursing and Canada) (at the time of the first meeting of the group, GlaxoSmithKline
Midwifery, Trinity College (Dublin, Ireland); Deborah Cook, MD, Canada, Mississauga, Canada); Drummond Rennie, MD, FRCP, FACP,
Departments of Medicine, Clinical Epidemiology and Biostatistics, University of California San Francisco (San Francisco, California, US);
McMaster University (Hamilton, Canada); Roberto D’Amico, PhD, Margaret Sampson, MLIS, Children’s Hospital of Eastern Ontario
Università di Modena e Reggio Emilia (Modena, Italy) and Centro (Ottawa, Canada); Kenneth F. Schulz, PhD, MBA, Family Health
Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri International (Durham, North Carolina, US); Paul G. Shekelle, MD,
(Milan, Italy); Jonathan J. Deeks, PhD, University of Birmingham PhD, Southern California Evidence Based Practice Center (Santa
(Birmingham, UK); P. J. Devereaux, MD, PhD, Departments of Monica, California, US); Jennifer Tetzlaff, BSc, Ottawa Methods
Medicine, Clinical Epidemiology and Biostatistics, McMaster University Centre, Ottawa Hospital Research Institute (Ottawa, Canada); David
(Hamilton, Canada); Kay Dickersin, PhD, Johns Hopkins Bloomberg Tovey, FRCGP, The Cochrane Library, Cochrane Collaboration
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