Moher et al.

Systematic Reviews 2015, 4:1

http://www.systematicreviewsjournal.com/content/4/1/1

RESEARCH Open Access

Preferred reporting items for systematic review

and meta-analysis protocols (PRISMA-P) 2015
statement
David Moher1*, Larissa Shamseer1, Mike Clarke2, Davina Ghersi3, Alessandro Liberatiˆ, Mark Petticrew4,
Paul Shekelle5, Lesley A Stewart6 and PRISMA-P Group

Abstract
Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the
review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding
and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in
completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for
Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist
intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those
commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant
protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the
completeness and transparency of a systematic review protocol submitted for publication in a journal or other
medium.

Background and using data from primary research, since planning

Systematic reviews are the reference standard for syn- provides an opportunity for the review team to antici-
thesizing evidence in health care because of their meth- pate potential problems. When clearly reported proto-
odological rigor. They are used to support the cols are made available, they enable readers to identify
development of clinical practice guidelines and inform deviations from planned methods in completed reviews
clinical decision-making. They are becoming increas- and whether they bias the interpretation of a review re-
ingly common; in 2010, 11 new reviews were estimated sults and conclusions. Bias related to the selective
to be published daily [1]. Ideally, systematic reviews are reporting of outcomes has been characterized as a ser-
based on pre-defined eligibility criteria and conducted ious problem in clinical research, including systematic
according to a pre-defined methodological approach as reviews [2-7].
outlined in an associated protocol. Until recently, systematic review protocols were gener-
The preparation of a protocol is an essential compo- ally available only through select organizations, such as
nent of the systematic review process; it ensures that a The Cochrane [8] and Campbell Collaborations and the
systematic review is carefully planned and that what is Joanna Briggs Institute, for which the preparation of a
planned is explicitly documented before the review protocol is mandatory. Outside of these organizations,
starts, thus promoting consistent conduct by the review the existence of a protocol is infrequently reported in
team, accountability, research integrity, and transparency completed reviews [9,10]. Fewer than half of 300 system-
of the eventual completed review. A protocol may also atic reviews indexed on MEDLINE in November 2004
reduce arbitrariness in decision-making when extracting (most recent generalizable sample; 2014 update under-
way) report working from a protocol [10], 80% of which
* Correspondence: [email protected] are non-Cochrane affiliated. Of the non-Cochrane thera-
ˆDeceased
1
Ottawa Hospital Research Institute and University of Ottawa, Ottawa,
peutic reviews, only 11% mentioned the existence of a
Canada protocol [10]. The majority of reviews in health care are
Full list of author information is available at the end of the article

© 2015 Moher et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
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conducted and published outside of Cochrane, however analyses of studies evaluating health care interventions
[10]. The paucity of protocols may be due, in part, to the —the Preferred Reporting Items for Systematic reviews
authors’ lack of knowledge about how to write them and and Meta-Analyses (PRISMA, www.prisma-statement.
what to include. Currently, little succinct guidance is org) [12,13]—we have developed PRISMA for Protocols
available for those preparing systematic review protocols, (PRISMA-P) 2014. Table 1 summarizes the difference
although the recent Standards for Systematic Reviews in intentions between PRISMA-P and PROSPERO.
prepared by the Institute of Medicine (IOM) provide The aim of PRISMA-P 2015 is to improve the quality
some guidance toward addressing this gap [11]. of systematic review protocols, similar to the impact
Many groups have called for the widespread preparation achieved by other reporting guidelines [18-20]. By help-
and registration of systematic review protocols in order ing authors document an a priori road map of their sys-
to increase the availability and accessibility of a priori tematic review, PRISMA-P also has the potential to
methods for systematic reviews [12-14]. Such an effort improve the conduct of systematic reviews, as has been
may reduce the duplication of effort [15] and reduce suggested of other reporting guidelines [21]. This State-
the publication bias of systematic reviews. This chal- ment paper summarizes the development of the guide-
lenge has been taken up by the Centre for Reviews and line and presents the PRISMA-P checklist.
Dissemination, University of York, which has spearheaded
the establishment of an international register—PROS- Terminology
PERO (International Prospective Register of Ongoing There is no standard definition for a systematic review
Systematic Reviews, http://www.crd.york.ac.uk/prospero) and meta-analysis protocol, and we note that some ter-
[16,17]. The register, which enables the permanent docu- minology contained within these definitions may carry
mentation of 22 mandatory (and 18 optional) items about different meanings for different readers (i.e., ‘systematic
the a priori design and conduct of a review, was launched search’). The terms ‘systematic review’ , ‘meta-analysis,’
in February 2011. At the time of writing, >5,000 system- and ‘protocol’ are defined in Table 2. The former two
atic review protocols from over 70 countries have been terms are in accordance with the definitions reported in
registered since its inception. Starting in October 2013, the PRISMA Statement [13] and are in line with those
new Cochrane protocols were and continue to be auto- used by the Agency for Healthcare Research and Qual-
matically added to PROSPERO. ity’s Evidence-based Practice Center (EPC) program [22],
Along with the improved accessibility of protocols The Cochrane Collaboration [23], and the 2011 guidance
through registration comes the need for strengthened from the Institute of Medicine [11]. The definition pro-
transparency, accuracy, and completeness of the reports vided is a culmination of the terminology used by the
of protocols intended for dissemination. A template to Standard Protocol Items: Recommendations for Inter-
aid in the preparation of systematic review protocols, ventional Trials (SPIRIT) 2013 initiative [24], the PROS-
such as a reporting guideline, may help achieve this. Fur- PERO register, and the IOM Standards (Table 2).
thermore, such guidance will enable authors to create a
clear and complete document of their a priori methods, Scope
which may facilitate the registration of key information The PRISMA-P checklist is intended primarily for the
into the PROSPERO database. Building on an estab- preparation of protocols of systematic reviews and meta-
lished guideline for systematic reviews and meta- analyses that summarize aggregate data from studies,

Table 1 PROSPERO and PRISMA-P

Definition and objective
PROSPERO: International Prospective An online portal through which to register the intention to conduct a systematic review, with health-related
Register of Systematic Reviews outcomes, before it is initiated [16]. One of the main goals of PROSPERO is to make the intent of systematic
reviews known before they are conducted in order to reduce the unplanned duplication of systematic
reviews [15]. In addition, by requiring the documentation of a priori methods, the register facilitates
increased transparency in the review process by allowing readers of systematic reviews to compare
methods, outcomes, and analyses carried out with those planned in advance and judge whether such
changes impact the results of a review.
PRISMA-P: Preferred Reporting Items for A guideline to help authors prepare protocols for planned systematic reviews and meta-analyses that
Systematic Review and Meta-Analysis provides them with a minimum set of items to be included in the protocol. A protocol is intended to
Protocols provide the rationale for the review and pre-planned methodological and analytic approach, prior to
embarking on a review. Investigators should prepare a review protocol in advance of registering it in
PROSPERO so that details requiring further consideration may be thought through in advance, avoiding
the need for multiple amendments to registration information. PRISMA-P items have been derived largely
from the PRISMA checklist and items of the PROSPERO register, in order to facilitate seamless registration.
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Table 2 PRISMA-P terminology

Term Definition
Systematic A systematic review attempts to collate all relevant evidences that fits pre-specified eligibility criteria to answer a specific research
review question. It uses explicit, systematic methods to minimize bias in the identification, selection, synthesis, and summary of studies.
When done well, this provides reliable findings from which conclusions can be drawn and decisions made [25,26]. The key
characteristics of a systematic review are (a) a clearly stated set of objectives with an explicit, reproducible methodology; (b) a
systematic search that attempts to identify all studies that would meet the eligibility criteria; (c) an assessment of the validity of the
findings of the included studies (e.g., assessment of risk of bias and confidence in cumulative estimates); and (d) systematic
presentation, and synthesis, of the characteristics and findings of the included studies
Meta-analysis Meta-analysis is the use of statistical techniques to combine and summarize the results of multiple studies; they may or may be
contained within a systematic review. By combining data from several studies, meta-analyses can provide more precise estimates
of the effects of health care than those derived from the individual studies
Protocol In the context of systematic reviews and meta-analyses, a protocol is a document that presents an explicit plan for a systematic
review. The protocol details the rationale and a priori methodological and analytical approach of the review

particularly the evaluations of the effects of interven- Pre-meeting activities

tions. There are many review types that are outside of In developing the PRISMA-P checklist, the steering
this scope. As such, given the general lack of protocol committee compiled a list of items from various tools
guidance for other types of reviews, we encourage re- relating to the preparation of systematic review proto-
viewers preparing any type of review protocol to make cols for discussion at a consensus meeting of experts.
use of PRISMA-P as applicable. Readers can also use the Specifically, we mapped items from a Delphi exercise
checklist to assess the completeness of the reporting of carried out during the development of PROSPERO [28],
published protocols. However, it is not recommended to PROSPERO register items, PRISMA checklist items [13],
use the checklist as an assessment tool to gauge the ap- SPIRIT 2013 checklist items [29], and items of IOM
propriateness of the methods of a systematic review Standard 2.6 [11] against each other to identify unique
protocol; it has not been validated for that purpose. and overlapping concepts. Lessons learned from the de-
velopment of the SPIRIT checklist with respect to the
concept and content of research protocols were used to
Development of PRISMA-P 2015 guide discussion and debate at the meeting.
An international steering committee (MC, DG, AL, DM,
MP, PS, and LAS) comprising members with wide-ranging
PRISMA-P consensus meeting
experience in systematic review methodology, protocol
Twenty-three international experts attended the
registry development, and reporting guideline development
PRISMA-P consensus meeting on June 23–24, 2011, in
led the development of PRISMA-P, coordinated by LS. The
Rockville, MD, USA to gain consensus on and reduce
process proposed by the Enhancing the Quality and Trans-
the number of potential PRISMA-P items. Delegates in-
parency of Health Research (EQUATOR) Network was
cluded journal editors, systematic review methodologists
used to guide PRISMA-P development [27]. The process
(including directors and representatives from inter-
has 18 step-by-step recommendations grouped into five
national Cochrane Centres, Agency for Healthcare Re-
main stages:
search and Quality’s (AHRQ’s) Evidence-based Practice
Centres, and the UK National Institute for Health Re-
1. Initial steps (determine the need for a reporting
search), reporting guideline developers, information spe-
guideline);
cialists, biostatisticians, and health research funders.
2. Pre-meeting activities (identify contributors, conduct
Through group discussion at the meeting, 38 potential
Delphi exercise, generate a list of potential items,
checklist items were reduced to 22.
and prepare for face-to-face meeting);
3. Face-to-face consensus meeting (present results of
pre-meeting activities and relevant evidence); Post-meeting activities
4. Post-meeting activities (develop guidance Statement, Following the meeting, the steering committee revised
Explanation and Elaboration document, and a the draft 22-item checklist and refined their wording
publication strategy); such that they accurately reflected meeting discussions.
5. Post-publication activities (encourage uptake of The draft checklist was also presented to the PROS-
guideline). PERO group, at a scientific meeting of the Cochrane
Collaboration, for input and feedback and to AHRQ’s
The first stage, ‘Initial steps,’ was described above; de- Learning Network. After each of these reviews, the steer-
tails of the remaining four steps are below. ing committee made minor amendments to the items.
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The checklist was then circulated to all meeting invitees freely available on the websites of the PRISMA Group
for critical input. (www.prisma-statement.org) and EQUATOR Network
(www.equator-network.org). The PROSPERO register
The PRISMA-P 2015 checklist also contains a link to the guidance to encourage regis-
The final PRISMA-P 2015 checklist contains 17 numbered trants to prepare a complete documentation of their
items (26 including sub-items) Items are categorized into protocol if they have not done so already.
three main sections: administrative information, introduc- We plan to develop an educational webinar about the
tion, and methods (Table 3). rationale, usefulness, and potential impact of PRISMA-P,
We made a conscious effort to harmonize the PRISMA- similar to what was done for PRISMA [31]. In addition,
P checklist items with the items of the PRISMA checklist the potential for PRISMA-P 2015 to be used as an educa-
to facilitate authors in transitioning their protocol into tional tool for authors, peer reviewers, and editors will be
a report of a systematic review. Thirteen PRISMA-P explored. Targeted implementation activities for PRISMA-
sub-items have existing PRISMA counterparts. Where P will be developed in a systematic manner together with
PRISMA wording or content did not sufficiently ad- experts in knowledge translation. The PRISMA website
dress protocol reporting, checklist items were modified. and social media (@PRISMAStatement, www.twitter.
Readers familiar with PRISMA will notice that PRISMA- com/PRISMAStatement) will be used to make an-
P does not contain a flow diagram documenting the flow nouncements about the launch of PRISMA-P and edu-
of studies throughout the systematic review process. Such cational initiatives.
documentation is possible only after a review has been car-
ried out and remains an essential component to include in Endorsement
the report of a completed systematic review or meta- We encourage journals publishing systematic review prod-
analysis; for further guidance, see the PRISMA Explanation ucts to modify their ‘Instructions for Authors’ section to
and Elaboration document [12]. endorse PRISMA-P 2015 and to consider publishing sys-
We strongly recommend that the present document tematic review protocols, if they do not do so already. We
and the accompanying PRISMA-P 2015 Explanation and plan to communicate with known endorsers of PRISMA
Elaboration document [30], which includes examples of (http://prisma-statement.org/endorsers.htm) as well as to
good reporting, rationale, and evidence (where available), other, relevant non-endorsing journals, to ask them to
be read together with the PRISMA-P 2015 checklist. consider extending their support to PRISMA-P.
To help ensure optimal uptake by systematic reviewers,
PRISMA-P 2015 explanation and elaboration we propose a uniform endorsement policy across organi-
Once the steering committee prepared the PRISMA-P zations and journals involved in the development and
2015 Statement and checklist, they drafted the content publication of systematic review protocols, demonstrated
of an Explanation and Elaboration document, with as- by the adoption of the following statement:
sistance from the larger PRISMA-P group. The explana-
tory text was derived largely from discussions at the ‘[this organization/journal] requires a completed
PRISMA-P meeting (recorded at the time) as well as the PRISMA-P 2015 checklist as a condition of submission
PRISMA Explanation and Elaboration document [12]. of systematic review protocols. We recommend that,
Examples of well-reported PRISMA-P items came from while completing the PRISMA-P 2015 checklist, you
protocols registered in the PROSPERO database, ensure your protocol addresses all items. Taking the
AHRQ’s EPC Program, and the Cochrane Database of time to ensure that your protocol adheres to these
Systematic Reviews or those published elsewhere. After basic reporting elements will improve your manuscript
the entire group had an opportunity to suggest addi- and potentially enhance its chances of eventual
tions, deletions, and changes, the steering committee acceptance.’
combined all amendments to create the PRISMA-P 2014
Explanation and Elaboration document [30]. Such a statement could be included in a journal’s ‘In-
structions to Authors,’ or for funding agencies and those
Post-publication activities commissioning systematic reviews, in their Application
The post-publication activities recommended by EQUA- Guidelines, recommending that applicants developing
TOR include seeking and responding to criticism, encour- the proposals of systematic reviews for funding use
aging the endorsement of and adherence to the guideline PRISMA-P 2014. Peer reviewers and scientific commit-
from various stakeholders, translating the guideline into tees can also use the checklist to gauge the extent to
other languages, evaluating its impact, ensuring website which protocols include necessary information.
development, and updating of the guideline. The As has been done for previous reporting guidelines
PRISMA-P 2015 checklist and related publications are [18,32] we plan to evaluate whether and to what degree
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Table 3 PRISMA-P 2015 checklist: recommended items to include in a systematic review protocola
Section/topic Item # Checklist item
ADMINISTRATIVE INFORMATION
Title
Identification 1a Identify the report as a protocol of a systematic review
Update 1b If the protocol is for an update of a previous systematic review, identify as such
Registration 2 If registered, provide the name of the registry (e.g., PROSPERO) and registration number
Authors
Contact 3a Provide name, institutional affiliation, and e-mail address of all protocol authors; provide physical
mailing address of corresponding author
Contributions 3b Describe contributions of protocol authors and identify the guarantor of the review
Amendments 4 If the protocol represents an amendment of a previously completed or published protocol,
identify as such and list changes; otherwise, state plan for documenting important protocol
amendments
Support
Sources 5a Indicate sources of financial or other support for the review
Sponsor 5b Provide name for the review funder and/or sponsor
Role of sponsor/ 5c Describe roles of funder(s), sponsor(s), and/or institution(s), if any, in developing the protocol
funder
INTRODUCTION
Rationale 6 Describe the rationale for the review in the context of what is already known
Objectives 7 Provide an explicit statement of the question(s) the review will address with reference to participants,
interventions, comparators, and outcomes (PICO)
METHODS
Eligibility criteria 8 Specify the study characteristics (e.g., PICO, study design, setting, time frame) and report characteristics
(e.g., years considered, language, publication status) to be used as criteria for eligibility for the review
Information sources 9 Describe all intended information sources (e.g., electronic databases, contact with study authors,
trial registers, or other grey literature sources) with planned dates of coverage
Search strategy 10 Present draft of search strategy to be used for at least one electronic database, including planned
limits, such that it could be repeated
Study records
Data management 11a Describe the mechanism(s) that will be used to manage records and data throughout the review
Selection process 11b State the process that will be used for selecting studies (e.g., two independent reviewers) through each
phase of the review (i.e., screening, eligibility, and inclusion in meta-analysis)
Data collection process 11c Describe planned method of extracting data from reports (e.g., piloting forms, done independently, in
duplicate), any processes for obtaining and confirming data from investigators
Data items 12 List and define all variables for which data will be sought (e.g., PICO items, funding sources), any
pre-planned data assumptions and simplifications
Outcomes and 13 List and define all outcomes for which data will be sought, including prioritization of main and
prioritization additional outcomes, with rationale
Risk of bias in 14 Describe anticipated methods for assessing risk of bias of individual studies, including whether this will
individual studies be done at the outcome or study level, or both; state how this information will be used in data synthesis
Data
Synthesis 15a Describe criteria under which study data will be quantitatively synthesized
15b If data are appropriate for quantitative synthesis, describe planned summary measures, methods of
handling data, and methods of combining data from studies, including any planned exploration of
consistency (e.g., I2, Kendall’s tau)
15c Describe any proposed additional analyses (e.g., sensitivity or subgroup analyses, meta-regression)
15d If quantitative synthesis is not appropriate, describe the type of summary planned
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Table 3 PRISMA-P 2015 checklist: recommended items to include in a systematic review protocola (Continued)
Meta-bias(es) 16 Specify any planned assessment of meta-bias(es) (e.g., publication bias across studies, selective
reporting within studies)
Confidence in 17 Describe how the strength of the body of evidence will be assessed (e.g., GRADE)
cumulative evidence
PRISMA-P Preferred Reporting Items for Systematic review and Meta-Analysis Protocols.
a
It is strongly recommended that this checklist be read in conjunction with the PRISMA-P Explanation and Elaboration [30] for important clarification on the items.
Amendments to a review protocol should be tracked and dated. The copyright for PRISMA-P (including checklist) is held by the PRISMA-P Group and is distributed
under a Creative Commons Attribution License 4.0.

endorsement of PRISMA-P 2015 by journals (and poten- Implementation

tially by other organizations) influences the complete- The current system of implementing reporting guide-
ness of reported protocols. Such an evaluation will be lines is not optimal. At present, their primary mechan-
planned after allowing sufficient time for the wide dis- ism of uptake is through endorsement by journals at
semination of PRISMA-P 2015. their discretion, if at all. In journals that do endorse

Table 4 Proposed stakeholders, actions, and potential benefits for supporting adherence to PRISMA-P
Stakeholder Proposed action Potential benefits
Funders Promote or mandate adherence to PRISMA-P or use PRISMA-P as Improved quality, completeness, and consistency
a template for systematic review proposals for grant applications of systematic review proposal submissions
Standardized protocol content will improve peer
review efficiency and investigator understanding
of requirements
Systematic review authors/ Use/adhere to PRISMA-P during protocol development Improved quality, completeness, and consistency
groups/organizations of protocol content
Enables reviewers to anticipate and avoid future
changes to review methods (i.e., outcomes)
Increased awareness of minimum content for
protocol reporting
Improved completeness of reporting of
completed reviews
PROSPERO (and other Encourage the development of PRISMA-P-based protocols Improved quality of registry entries
review registries)
Improved consistency across registry entries,
protocols, and systematic reviews
Practice guideline Use PRISMA-P to gauge the completeness of protocols and Enables easy comparison across protocols, registry
developers facilitate detection of selective reporting when considering entries, and completed systematic reviews
reviews for guideline inclusion
Policymakers Advocate use of PRISMA-P by those funding and carrying May yield better quality, more complete, and more
out systematic reviews consistent reviews to inform decision-making
Journal editors Encourage compliance to PRISMA-P for authors submitting Improved quality, completeness, and consistency
protocols for publication of protocols over those published in journals not
endorsing PRISMA-P
Offer PRISMA-P as a template to assist in protocol Increased efficiency in protocol peer and
writing for publication author understanding of journal requirements
Improved transparency and interpretation
of reviews by readers
Educators Use PRISMA-P as a training tool Simplified teaching and grading of protocols
Encourage adherence in students submitting protocols Improved quality, completeness, and
for coursework consistency of protocol content
Students Develop protocols for coursework or research using PRISMA-P Improved understanding of the minimum
protocol content
Well-trained systematic reviewer going
into the workforce
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guidelines, language describing their support is often described reasons for the change in the completed review
vague, leaving authors unclear on what they are sup- [3]. Discrepant outcomes added or upgraded from second-
posed to do with a given reporting guideline during the ary to primary at the review stage were more likely to be
submission process [33]. Furthermore, policies around statistically significant than those outcomes that had not
how journal editors and peer reviewers should ensure changed. This practice (i.e., including, excluding, or chan-
and/or enforce adherence to reporting checklists are ging outcomes in association with the strength or direc-
even less clear, if they exist at all [34]. Other barriers to tion of findings) has the potential to bias the findings of
implementation may include a lack of awareness of the any meta-analysis and the review’s conclusions. As review
guideline and perceived burden of using a reporting protocols are expected to become increasingly available
guideline checklist during the editorial process [35]. with the advent of PROSPERO, clear reporting will be-
Some well-known checklists, such as PRISMA, include come essential to facilitate the identification of discrepan-
a column to the right of the main checklists in which cies between protocol and review by readers and help
users report the page number on which a specific item is them determine whether they need to be cautious in inter-
reported. This was initially intended to help authors en- preting findings.
sure each checklist item is addressed and to aid peer re- Reporting and publishing protocols is an important step
viewers in locating reported text for each item within a in increasing the transparency of the research process and
document. However, this system is not optimal. One reliability of published papers. For example, some journals
major problem is that peer reviewers still have to search require a copy of the protocol as part of the peer review
within a considerable body of text to locate the exact process of randomized trials. As of 1 March 2014, BioMed
text describing a checklist item. When multiple items Central has published 4,158 trial protocols across 66 of its
are listed separately but reported together or vice versa, 258 open-access journals, including 1,026 in Trials. Sys-
this problem is compounded, because exactly which tematic Reviews, a BioMed Central journal launched in
content pertains to each item may remain unclear. February 2012, is committed to publishing systematic re-
The lack of implementation and adherence to report- view products, including protocols [41], and has published
ing guidelines is systemic; additional authorities encoun- 142 protocols since inception (to 8 June 2014).
tered early in the research process should promote a Journals, granting agencies, and systematic review or-
clearer message about author adherence to reporting ganizations are encouraged to endorse PRISMA-P 2015
standards if improvements in reporting are to be made. in their ‘Instructions to Authors’ and guidance for appli-
In targeting protocols of systematic reviews, PRISMA-P cants and to implement its use during their peer review
has a unique opportunity to not only affect the way in process of systematic review proposals. Reviewers are
which protocols are reported but to also impact the way encouraged to use the PRISMA-P checklist and Explan-
in which reviews are eventually conducted, perhaps ation and Elaboration [30] document to guide them
allowing for a more seamless transition into a com- through the documentation of a protocol. Doing so will
pletely reported systematic review. enhance the completeness of reporting of review proto-
To overcome known challenges with reporting guideline cols, facilitate the assessment of potential in systematic
uptake [36,37], we are developing a prospective imple- reviews, and hopefully strengthen the methodological
mentation strategy for PRISMA-P 2015 using knowledge quality and reliability of completed systematic reviews.
translation principles involving theoretically derived inter-
Competing interests
ventions [37] which have demonstrated effectiveness in
The PRISMA-P 2015 initiative was supported by the AHRQ, USA (Contract No.
the development of implementation interventions for clin- HHSA 290 2007 10059 I) and the Canadian Institutes for Health Research
ical practice guidelines [38,39]. An initial list of proposed (Reference No. 114369). This manuscript does not reflect the opinions of
either agency; one author, SC, is an employee of AHRQ. MC, DG, DM, MP,
stakeholders who can assist in the implementation of
and LAS are members of the Advisory Board for PROSPERO. DGA, SC, MC,
PRISMA-P, along with proposed actions and benefits, is JG, MH, JM, and MP are members of the Editorial Board, and DM, PS, and
provided in Table 4. LAS are co-Editors in Chief of Systematic Reviews. None of the authors who
are editors of Systematic Reviews were involved in the handling of this
paper or the decision to publish it.
Discussion
Studies comparing trial protocols to final reports have Authors’ contributions
widely documented both the presence and the extent of DM, LS, MC, DG, AL, MP, PS, and LAS conceived this paper. DM and LS
drafted the article, and all authors critically revised it for important
reporting biases in publications of randomized trials intellectual content. All authors approved the final version of this article. DM
[2,40]. Protocols for systematic reviews are rarely available is the guarantor of this work.
for such comparisons, with the exception of select organi-
zations. Of 288 reviews with available protocols in a 2006/ Acknowledgements
The PRISMA-P steering committee would like to thank the following staff
2007 cohort, 64 (22%) were observed to have at least one from the Ottawa Hospital Research Institute (OHRI): Jodi Peters for her efforts
discrepant outcome with their completed reviews; only 4 organizing the PRISMA-P consensus meeting, Michael Zhao for his assistance
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in preparing documents for the PRISMA-P meeting, Dr. Mohammed Ansari 5. Dwan K, Gamble C, Williamson PR, Kirkham JJ, Reporting Bias Group:
for valuable input and feedback throughout the process, and Justin Thielman Systematic review of the empirical evidence of study publication bias
for his assistance during the preparation of the PRISMA-P manuscripts. and outcome reporting bias—an updated review. PLoS ONE 2013,
8(7):e66844.
6. Norris SL, Holmer HK, Ogden LA, Fu R, Abou-Setta AM, Viswanathan MS,
Dedication
McPheeters ML: Selective Outcome Reporting as a Source of Bias in Reviews of
The PRISMA-P 2015 initiative is dedicated to our colleague Alessandro Liberati
Comparative Effectiveness (Prepared by the Oregon Evidence-Based Practice Center
(1954–2012) who passed away during the time in which PRISMA-P 2015 was
Under Contract no. 290-2007-10057-I). Rockville: Agency for Healthcare Research
under development and whose contributions to this work were invaluable.
and Quality; 2012. Report No.: AHRQ Publication No. 12-EHC110-EF.
7. Page MJ, McKenzie JE, Kirkham J, Dwan K, Kramer S, Green S, Forbes A: Bias
PRISMA-P group (listed alphabetically) due to selective inclusion and reporting of outcomes and analyses in
Douglas G Altman, DSc, Centre for Statistics in Medicine (CSM), University of systematic reviews of randomised trials of healthcare interventions.
Oxford, (Oxford, UK); Alison Booth, Centre for Reviews and Dissemination (CRD), Cochrane Lib 2014, (10):Art No.:MR000035. doi:10.1002/14651858.MR000035.
University of York (York, UK); An-Wen Chan, Women’s College Research pub2.
Institute, University of Toronto (Toronto, Canada); Stephanie Chang, 8. Higgins JPT, Green S (Eds): Cochrane Handbook for Systematic Reviews of
Agency for Healthcare Research and Quality (Rockville, USA); Mike Clarke, Interventions Version 5.1.0: updated March 2011. The Cochrane Collaboration;
Queen’s University of Belfast (Belfast, Ireland); Tammy Clifford, Canadian 2011. Available from [www.cochrane-handbook.org]
Agency for Drugs and Technologies in Health (CADTH) (Ottawa, Canada); 9. Ma B, Guo J, Qi G, Li H, Peng J, Zhang Y, Ding Y, Yang K: Epidemiology,
Kay Dickersin, Johns Hopkins Bloomberg School of Public Health; Matthias quality and reporting characteristics of systematic reviews of traditional
Egger, Institut für Sozial-und Präventivmedizin; Davina Ghersi, National Chinese medicine interventions published in Chinese journals. PLoS ONE
Health and Medical Research Council (Canberra, Australia); Peter C Gøtzsche, 2011, 6(5):e20185.
Nordic Cochrane Centre (Copenhagen, Denmark); Jeremy M Grimshaw, 10. Moher D, Tetzlaff J, Tricco AC, Sampson M, Altman DG: Epidemiology
Canadian Cochrane Centre and OHRI (Ottawa, Canada); Trish Groves, The and reporting characteristics of systematic reviews. PLoS Med 2007,
BMJ (London, UK); Mark Helfand, AHRQ EPC Scientific Resource Center, 4(3):e78.
Portland VA Research Foundation (Portland, USA); Julian Higgins, School of 11. Institute of Medicine. In Finding What Works in Health Care: Standards for
Social and Community Medicine (Bristol, UK); Toby Lasserson, Cochrane Systematic Reviews. Edited by Eden J, Levit L, Berg A, Morton S. Washington,
Editorial Unit (London, UK); Joseph Lau, Center for Evidence-based Medicine, DC: The National Academies Press; 2011.
Brown University (Providence, USA); Alessandro Liberati, University of Modena 12. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, Clarke
(Modena, Italy); Kathleen Lohr, Research Triangle Institute-University of North M, Devereaux PJ, Kleijnen J, Moher D: The PRISMA statement for reporting
Carolina EPC (Research Triangle Park, USA); Jessie McGowan, University of systematic reviews and meta-analyses of studies that evaluate health
Ottawa (Ottawa, Canada); David Moher, Clinical Epidemiology Program, OHRI, care interventions: explanation and elaboration. PLoS Med 2009,
and University of Ottawa (Ottawa, Canada); Cynthia Mulrow, Annals of 6(7):e1000100.
Internal Medicine (San Antonio, USA); Melissa Norton, PLoS Medicine 13. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group: Preferred
(London, UK); Matthew Page, Monash University (Australia); Mark Petticrew, reporting items for systematic reviews and meta-analyses: the PRISMA
London School of Hygiene and Tropical Medicine (London, UK); Margaret Statement. BMJ 2009, 339:b2535.
Sampson, Children’s Hospital of Eastern Ontario (Ottawa; Canada); Holger 14. Straus S, Moher D: Registering systematic reviews. CMAJ 2010, 182(1):13–14.
Schünemann, McMaster University (Hamilton, Canada); Larissa Shamseer, Clinical 15. Moher D, Booth A, Stewart L: How to reduce unnecessary duplication: use
Epidemiology Program, OHRI, and University of Ottawa (Ottawa; Canada); PROSPERO. BJOG 2014, 121:784–786.
Paul Shekelle, Southern California EPC, (Los Angeles, USA); Iveta Simera, 16. Booth A, Clarke M, Ghersi D, Moher D, Petticrew M, Stewart L: An
CSM, University of Oxford (Oxford, UK); Lesley A Stewart, CRD, University of international registry of systematic-review protocols. Lancet 2011,
York (York, UK); William Summerskill, The Lancet (London, UK); Jennifer Tetzlaff, 377(9760):108–109.
Clinical Epidemiology Program, OHRI (Ottawa, Canada); Thomas A Trikalinos, 17. Booth A, Clarke M, Dooley G, Ghersi D, Moher D, Petticrew M, Stewart L:
Center for Evidence-based Medicine, Brown University (Providence, USA); David The nuts and bolts of PROSPERO: an international prospective register of
Tovey, The Cochrane Library (London, UK); Lucy Turner, Clinical Epidemiology systematic reviews. Syst Rev 2012, 1:2.
Program, OHRI (Ottawa Canada); Evelyn Whitlock, Kaiser Permanente Research 18. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D: Does use of the
Affiliates EPC (Portland, USA). CONSORT statement impact the completeness of reporting of
randomised controlled trials published in medical journals? A Cochrane
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Received: 27 August 2014 Accepted: 26 November 2014
22. Methods Guide for Effectiveness and Comparative Effectiveness Reviews, AHRQ
Published: 1 January 2015
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doi:10.1186/2046-4053-4-1
Cite this article as: Moher et al.: Preferred reporting items for
systematic review and meta-analysis protocols (PRISMA-P) 2015
statement. Systematic Reviews 2015 4:1.

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