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What Is Preferred Reporting Items for Systematic Reviews and Meta-analyses

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Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 argument

  • Larissa Shamseer1,
  • Mike Clarke2,
  • Davina Ghersiiii,
  • Alessandro Liberati,
  • Mark Petticrew4,
  • Paul Shekellev,
  • Lesley A Stewart6 &
  • PRISMA-P Group

Systematic Reviews volume 4, Article number:i (2015) Cite this article

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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, too as the detection of modifications to methods and selective reporting in completed reviews. Nosotros 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 apply of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to judge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.

Peer Review reports

Groundwork

Systematic reviews are the reference standard for synthesizing show in health care considering of their methodological rigor. They are used to support the evolution of clinical do guidelines and inform clinical decision-making. They are becoming increasingly mutual; in 2010, 11 new reviews were estimated to be published daily [ane]. Ideally, systematic reviews are based on pre-defined eligibility criteria and conducted according to a pre-defined methodological approach as outlined in an associated protocol.

The preparation of a protocol is an essential component of the systematic review process; it ensures that a systematic review is carefully planned and that what is planned is explicitly documented earlier the review starts, thus promoting consistent comport by the review team, accountability, research integrity, and transparency of the eventual completed review. A protocol may also reduce arbitrariness in decision-making when extracting and using data from primary inquiry, since planning provides an opportunity for the review squad to anticipate potential problems. When clearly reported protocols are fabricated bachelor, they enable readers to place deviations from planned methods in completed reviews and whether they bias the interpretation of a review results and conclusions. Bias related to the selective reporting of outcomes has been characterized as a serious trouble in clinical inquiry, including systematic reviews [two–7].

Until recently, systematic review protocols were more often than not available only through select organizations, such as The Cochrane [eight] and Campbell Collaborations and the Joanna Briggs Establish, for which the preparation of a protocol is mandatory. Outside of these organizations, the being of a protocol is infrequently reported in completed reviews [9, 10]. Fewer than one-half of 300 systematic reviews indexed on MEDLINE in November 2004 (most recent generalizable sample; 2014 update underway) report working from a protocol [10], 80% of which are non-Cochrane affiliated. Of the non-Cochrane therapeutic reviews, but 11% mentioned the existence of a protocol [10]. The majority of reviews in health intendance are conducted and published outside of Cochrane, however [ten]. The paucity of protocols may be due, in part, to the authors' lack of cognition about how to write them and what to include. Currently, little succinct guidance is available for those preparing systematic review protocols, although the contempo Standards for Systematic Reviews prepared past the Found of Medicine (IOM) provide some guidance toward addressing this gap [eleven].

Many groups have chosen for the widespread preparation and registration of systematic review protocols in order to increase the availability and accessibility of a priori methods for systematic reviews [12–xiv]. Such an endeavour may reduce the duplication of effort [xv] and reduce the publication bias of systematic reviews. This challenge has been taken up by the Center for Reviews and Dissemination, Academy of York, which has spearheaded the establishment of an international register—PROSPERO (International Prospective Register of Ongoing Systematic Reviews, http://www.crd.york.ac.uk/prospero) [16, 17]. The annals, which enables the permanent documentation of 22 mandatory (and 18 optional) items virtually the a priori design and bear of a review, was launched in February 2011. At the time of writing, >5,000 systematic review protocols from over 70 countries have been registered since its inception. Starting in October 2013, new Cochrane protocols were and continue to be automatically added to PROSPERO.

Along with the improved accessibility of protocols through registration comes the need for strengthened transparency, accuracy, and completeness of the reports of protocols intended for dissemination. A template to aid in the preparation of systematic review protocols, such as a reporting guideline, may assist achieve this. Furthermore, such guidance will enable authors to create a clear and complete document of their a priori methods, which may facilitate the registration of key information into the PROSPERO database. Building on an established guideline for systematic reviews and meta-analyses of studies evaluating health intendance interventions—the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA, http://www.prisma-statement.org) [12, 13]—we have developed PRISMA for Protocols (PRISMA-P) 2014. Tabular array 1 summarizes the difference in intentions betwixt PRISMA-P and PROSPERO.

Table one PROSPERO and PRISMA-P

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The aim of PRISMA-P 2015 is to improve the quality of systematic review protocols, like to the impact achieved past other reporting guidelines [18–20]. By helping authors document an a priori route map of their systematic review, PRISMA-P likewise has the potential to improve the comport of systematic reviews, as has been suggested of other reporting guidelines [21]. This Statement paper summarizes the development of the guideline and presents the PRISMA-P checklist.

Terminology

In that location is no standard definition for a systematic review and meta-analysis protocol, and we note that some terminology contained within these definitions may carry different meanings for dissimilar readers (i.e., 'systematic search'). The terms 'systematic review', 'meta-analysis,' and 'protocol' are defined in Table 2. The one-time two terms are in accordance with the definitions reported in the PRISMA Argument [xiii] and are in line with those used by the Agency for Healthcare Research and Quality'south Evidence-based Exercise Center (EPC) program [22], The Cochrane Collaboration [23], and the 2011 guidance from the Institute of Medicine [xi]. The definition provided is a culmination of the terminology used by the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 initiative [24], the PROSPERO annals, and the IOM Standards (Tabular array 2).

Table 2 PRISMA-P terminology

Full size table

Scope

The PRISMA-P checklist is intended primarily for the preparation of protocols of systematic reviews and meta-analyses that summarize aggregate data from studies, particularly the evaluations of the effects of interventions. There are many review types that are outside of this scope. As such, given the general lack of protocol guidance for other types of reviews, we encourage reviewers preparing any blazon of review protocol to brand use of PRISMA-P equally applicable. Readers can also utilize the checklist to assess the abyss of the reporting of published protocols. However, it is not recommended to use the checklist as an cess tool to estimate the ceremoniousness of the methods of a systematic review protocol; it has non been validated for that purpose.

Development of PRISMA-P 2015

An international steering committee (MC, DG, AL, DM, MP, PS, and LAS) comprising members with wide-ranging experience in systematic review methodology, protocol registry development, and reporting guideline evolution led the development of PRISMA-P, coordinated by LS. The process proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network was used to guide PRISMA-P development [27]. The procedure has xviii step-by-step recommendations grouped into five main stages:

  1. 1.

    Initial steps (make up one's mind the need for a reporting guideline);

  2. 2.

    Pre-meeting activities (place contributors, behave Delphi do, generate a list of potential items, and prepare for contiguous meeting);

  3. iii.

    Face-to-confront consensus meeting (nowadays results of pre-meeting activities and relevant evidence);

  4. 4.

    Postal service-coming together activities (develop guidance Statement, Caption and Elaboration certificate, and a publication strategy);

  5. v.

    Mail-publication activities (encourage uptake of guideline).

The first phase, 'Initial steps,' was described higher up; details of the remaining iv steps are below.

Pre-meeting activities

In developing the PRISMA-P checklist, the steering committee compiled a listing of items from various tools relating to the training of systematic review protocols for discussion at a consensus coming together of experts. Specifically, we mapped items from a Delphi exercise carried out during the development of PROSPERO [28], PROSPERO register items, PRISMA checklist items [13], SPIRIT 2013 checklist items [29], and items of IOM Standard two.6 [11] against each other to identify unique and overlapping concepts. Lessons learned from the development of the SPIRIT checklist with respect to the concept and content of research protocols were used to guide word and debate at the meeting.

PRISMA-P consensus meeting

Twenty-three international experts attended the PRISMA-P consensus meeting on June 23–24, 2011, in Rockville, MD, The states to gain consensus on and reduce the number of potential PRISMA-P items. Delegates included periodical editors, systematic review methodologists (including directors and representatives from international Cochrane Centres, Agency for Healthcare Research and Quality's (AHRQ'southward) Evidence-based Practice Centres, and the UK National Institute for Health Research), reporting guideline developers, data specialists, biostatisticians, and health research funders. Through grouping give-and-take at the meeting, 38 potential checklist items were reduced to 22.

Post-meeting activities

Post-obit the meeting, the steering committee revised the draft 22-detail checklist and refined their wording such that they accurately reflected coming together discussions. The draft checklist was also presented to the PROSPERO group, at a scientific meeting of the Cochrane Collaboration, for input and feedback and to AHRQ'south Learning Network. Later on each of these reviews, the steering commission made minor amendments to the items. The checklist was then circulated to all meeting invitees for critical input.

The PRISMA-P 2015 checklist

The final PRISMA-P 2015 checklist contains 17 numbered items (26 including sub-items) Items are categorized into three main sections: administrative information, introduction, and methods (Tabular array three).

Table three PRISMA-P 2015 checklist: recommended items to include in a systematic review protocol a

Full size table

Nosotros fabricated a conscious effort to harmonize the PRISMA-P checklist items with the items of the PRISMA checklist to facilitate authors in transitioning their protocol into a report of a systematic review. Xiii PRISMA-P sub-items have existing PRISMA counterparts. Where PRISMA diction or content did not sufficiently address protocol reporting, checklist items were modified.

Readers familiar with PRISMA volition notice that PRISMA-P does not contain a flow diagram documenting the catamenia of studies throughout the systematic review procedure. Such documentation is possible only after a review has been carried out and remains an essential component to include in the report of a completed systematic review or meta-analysis; for farther guidance, see the PRISMA Caption and Elaboration document [12].

We strongly recommend that the present certificate and the accompanying PRISMA-P 2015 Explanation and Elaboration document [30], which includes examples of good reporting, rationale, and show (where available), be read together with the PRISMA-P 2015 checklist.

PRISMA-P 2015 explanation and elaboration

Once the steering committee prepared the PRISMA-P 2015 Argument and checklist, they drafted the content of an Explanation and Elaboration certificate, with assistance from the larger PRISMA-P group. The explanatory text was derived largely from discussions at the PRISMA-P meeting (recorded at the time) too as the PRISMA Explanation and Elaboration certificate [12]. Examples of well-reported PRISMA-P items came from protocols registered in the PROSPERO database, AHRQ's EPC Program, and the Cochrane Database of Systematic Reviews or those published elsewhere. After the entire group had an opportunity to suggest additions, deletions, and changes, the steering committee combined all amendments to create the PRISMA-P 2014 Explanation and Elaboration document [30].

Post-publication activities

The mail-publication activities recommended past EQUATOR include seeking and responding to criticism, encouraging the endorsement of and adherence to the guideline from various stakeholders, translating the guideline into other languages, evaluating its impact, ensuring website development, and updating of the guideline. The PRISMA-P 2015 checklist and related publications are freely available on the websites of the PRISMA Group (http://www.prisma-statement.org) and EQUATOR Network (http://www.equator-network.org). The PROSPERO annals also contains a link to the guidance to encourage registrants to prepare a complete documentation of their protocol if they have not washed and so already.

We plan to develop an educational webinar about the rationale, usefulness, and potential impact of PRISMA-P, similar to what was done for PRISMA [31]. In addition, the potential for PRISMA-P 2015 to exist used as an educational tool for authors, peer reviewers, and editors will be explored. Targeted implementation activities for PRISMA-P will exist developed in a systematic manner together with experts in knowledge translation. The PRISMA website and social media (@PRISMAStatement, http://world wide web.twitter.com/PRISMAStatement) will be used to make announcements about the launch of PRISMA-P and educational initiatives.

Endorsement

We encourage journals publishing systematic review products to alter their 'Instructions for Authors' section to endorse PRISMA-P 2015 and to consider publishing systematic review protocols, if they do not do so already. Nosotros plan to communicate with known endorsers of PRISMA (http://prisma-statement.org/endorsers.htm) likewise as to other, relevant non-endorsing journals, to ask them to consider extending their support to PRISMA-P.

To assist ensure optimal uptake past systematic reviewers, we suggest a uniform endorsement policy beyond organizations and journals involved in the development and publication of systematic review protocols, demonstrated past the adoption of the following statement:

'[this arrangement/journal] requires a completed PRISMA-P 2015 checklist as a condition of submission of systematic review protocols. We recommend that, while completing the PRISMA-P 2015 checklist, you ensure your protocol addresses all items. Taking the time to ensure that your protocol adheres to these bones reporting elements will improve your manuscript and potentially enhance its chances of eventual acceptance.'

Such a argument could be included in a periodical's 'Instructions to Authors,' or for funding agencies and those commissioning systematic reviews, in their Application Guidelines, recommending that applicants developing the proposals of systematic reviews for funding apply PRISMA-P 2014. Peer reviewers and scientific committees tin also utilize the checklist to approximate the extent to which protocols include necessary data.

As has been done for previous reporting guidelines [xviii, 32] we programme to evaluate whether and to what degree endorsement of PRISMA-P 2015 by journals (and potentially by other organizations) influences the completeness of reported protocols. Such an evaluation will be planned afterwards allowing sufficient time for the wide dissemination of PRISMA-P 2015.

Implementation

The current system of implementing reporting guidelines is non optimal. At present, their chief machinery of uptake is through endorsement by journals at their discretion, if at all. In journals that do endorse guidelines, language describing their support is often vague, leaving authors unclear on what they are supposed to exercise with a given reporting guideline during the submission process [33]. Furthermore, policies around how journal editors and peer reviewers should ensure and/or enforce adherence to reporting checklists are even less clear, if they be at all [34]. Other barriers to implementation may include a lack of awareness of the guideline and perceived burden of using a reporting guideline checklist during the editorial process [35].

Some well-known checklists, such as PRISMA, include a column to the right of the main checklists in which users report the page number on which a specific item is reported. This was initially intended to assist authors ensure each checklist item is addressed and to help peer reviewers in locating reported text for each item within a document. However, this system is not optimal. One major trouble is that peer reviewers however have to search within a considerable body of text to locate the exact text describing a checklist item. When multiple items are listed separately but reported together or vice versa, this problem is compounded, because exactly which content pertains to each item may remain unclear.

The lack of implementation and adherence to reporting guidelines is systemic; boosted authorities encountered early in the research process should promote a clearer message about author adherence to reporting standards if improvements in reporting are to exist made. In targeting protocols of systematic reviews, PRISMA-P has a unique opportunity to not only bear on the mode in which protocols are reported but to likewise impact the style in which reviews are somewhen conducted, peradventure allowing for a more seamless transition into a completely reported systematic review.

To overcome known challenges with reporting guideline uptake [36, 37], we are developing a prospective implementation strategy for PRISMA-P 2015 using knowledge translation principles involving theoretically derived interventions [37] which have demonstrated effectiveness in the development of implementation interventions for clinical practice guidelines [38, 39]. An initial list of proposed stakeholders who tin assist in the implementation of PRISMA-P, along with proposed actions and benefits, is provided in Table 4.

Table 4 Proposed stakeholders, deportment, and potential benefits for supporting adherence to PRISMA-P

Total size table

Discussion

Studies comparing trial protocols to concluding reports have widely documented both the presence and the extent of reporting biases in publications of randomized trials [2, twoscore]. Protocols for systematic reviews are rarely available for such comparisons, with the exception of select organizations. Of 288 reviews with available protocols in a 2006/2007 cohort, 64 (22%) were observed to have at least ane discrepant outcome with their completed reviews; only 4 described reasons for the alter in the completed review [3]. Discrepant outcomes added or upgraded from secondary to master at the review stage were more likely to exist statistically pregnant than those outcomes that had not changed. This do (i.east., including, excluding, or changing outcomes in association with the force or direction of findings) has the potential to bias the findings of any meta-assay and the review'southward conclusions. As review protocols are expected to become increasingly available with the advent of PROSPERO, articulate reporting will become essential to facilitate the identification of discrepancies between protocol and review by readers and help them determine whether they demand to exist cautious in interpreting findings.

Reporting and publishing protocols is an of import stride in increasing the transparency of the enquiry process and reliability of published papers. For example, some journals require a copy of the protocol as part of the peer review procedure of randomized trials. Equally of one March 2014, BioMed Central has published 4,158 trial protocols across 66 of its 258 open up-admission journals, including 1,026 in Trials. Systematic Reviews, a BioMed Central journal launched in February 2012, is committed to publishing systematic review products, including protocols [41], and has published 142 protocols since inception (to 8 June 2014).

Journals, granting agencies, and systematic review organizations are encouraged to endorse PRISMA-P 2015 in their 'Instructions to Authors' and guidance for applicants and to implement its use during their peer review procedure of systematic review proposals. Reviewers are encouraged to use the PRISMA-P checklist and Explanation and Elaboration [thirty] document to guide them through the documentation of a protocol. Doing and then will enhance the completeness of reporting of review protocols, facilitate the cess of potential in systematic reviews, and hopefully strengthen the methodological quality and reliability of completed systematic reviews.

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Acknowledgements

The PRISMA-P steering committee would like to thank the following staff from the Ottawa Infirmary Research Institute (OHRI): Jodi Peters for her efforts organizing the PRISMA-P consensus meeting, Michael Zhao for his assistance in preparing documents for the PRISMA-P meeting, Dr. Mohammed Ansari for valuable input and feedback throughout the process, and Justin Thielman for his assistance during the preparation of the PRISMA-P manuscripts.

Dedication

The PRISMA-P 2015 initiative is dedicated to our colleague Alessandro Liberati (1954–2012) who passed away during the fourth dimension in which PRISMA-P 2015 was under development and whose contributions to this work were invaluable.

PRISMA-P group (listed alphabetically)

Douglas 1000 Altman, DSc, Centre for Statistics in Medicine (CSM), University of Oxford, (Oxford, United kingdom); Alison Booth, Centre for Reviews and Dissemination (CRD), University of York (York, UK); An-Wen Chan, Women's College Inquiry Found, University of Toronto (Toronto, Canada); Stephanie Chang, Agency for Healthcare Enquiry and Quality (Rockville, U.s.); Mike Clarke, Queen's University of Belfast (Belfast, Ireland); Tammy Clifford, Canadian Agency for Drugs and Technologies in Health (CADTH) (Ottawa, Canada); Kay Dickersin, Johns Hopkins Bloomberg School of Public Health; Matthias Egger, Institut für Sozial-und Präventivmedizin; Davina Ghersi, National Health and Medical Research Council (Canberra, Commonwealth of australia); Peter C Gøtzsche, Nordic Cochrane Eye (Copenhagen, Denmark); Jeremy Thousand Grimshaw, Canadian Cochrane Eye and OHRI (Ottawa, Canada); Trish Groves, The BMJ (London, U.k.); Marking Helfand, AHRQ EPC Scientific Resource Eye, Portland VA Research Foundation (Portland, USA); Julian Higgins, School of Social and Community Medicine (Bristol, UK); Toby Lasserson, Cochrane Editorial Unit (London, United kingdom of great britain and northern ireland); Joseph Lau, Center for Testify-based Medicine, Brown University (Providence, USA); Alessandro Liberati, Academy of Modena (Modena, Italy); Kathleen Lohr, Research Triangle Establish-University of N Carolina EPC (Research Triangle Park, USA); Jessie McGowan, University of Ottawa (Ottawa, Canada); David Moher, Clinical Epidemiology Program, OHRI, and University of Ottawa (Ottawa, Canada); Cynthia Mulrow, Register of Internal Medicine (San Antonio, USA); Melissa Norton, PLoS Medicine (London, Uk); Matthew Folio, Monash University (Australia); Mark Petticrew, London Schoolhouse of Hygiene and Tropical Medicine (London, United kingdom of great britain and northern ireland); Margaret Sampson, Children'due south Hospital of Eastern Ontario (Ottawa; Canada); Holger Schünemann, McMaster Academy (Hamilton, Canada); Larissa Shamseer, Clinical Epidemiology Plan, OHRI, and University of Ottawa (Ottawa; Canada); Paul Shekelle, Southern California EPC, (Los Angeles, USA); Iveta Simera, CSM, University of Oxford (Oxford, UK); Lesley A Stewart, CRD, University of York (York, UK); William Summerskill, The Lancet (London, United kingdom of great britain and northern ireland); Jennifer Tetzlaff, Clinical Epidemiology Program, OHRI (Ottawa, Canada); Thomas A Trikalinos, Centre for Prove-based Medicine, Chocolate-brown Academy (Providence, USA); David Tovey, The Cochrane Library (London, UK); Lucy Turner, Clinical Epidemiology Plan, OHRI (Ottawa Canada); Evelyn Whitlock, Kaiser Permanente Research Affiliates EPC (Portland, USA).

Author information

Affiliations

  1. Ottawa Hospital Research Constitute and University of Ottawa, Ottawa, Canada

    David Moher & Larissa Shamseer

  2. Queen's Academy Belfast, Belfast, Ireland

    Mike Clarke

  3. National Wellness and Medical Research Quango, Canberra, Australia

    Davina Ghersi

  4. London School of Hygiene and Tropical Medicine, London, UK

    Mark Petticrew

  5. Southern California Prove-based Practise Center, Santa Monica, CA, Us

    Paul Shekelle

  6. Centre for Reviews and Dissemination, Academy of York, York, UK

    Lesley A Stewart

Consortia

PRISMA-P Group

Corresponding writer

Correspondence to David Moher.

Additional information

Competing interests

The PRISMA-P 2015 initiative was supported by the AHRQ, USA (Contract No. HHSA 290 2007 10059 I) and the Canadian Institutes for Health Research (Reference No. 114369). This manuscript does not reverberate the opinions of either agency; one writer, SC, is an employee of AHRQ. MC, DG, DM, MP, and LAS are members of the Advisory Board for PROSPERO. DGA, SC, MC, JG, MH, JM, and MP are members of the Editorial Board, and DM, PS, and 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 determination to publish information technology.

Authors' contributions

DM, LS, MC, DG, AL, MP, PS, and LAS conceived this newspaper. DM and LS drafted the article, and all authors critically revised information technology for of import intellectual content. All authors approved the concluding version of this article. DM is the guarantor of this work.

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Moher, D., Shamseer, L., Clarke, G. et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 4, 1 (2015). https://doi.org/ten.1186/2046-4053-iv-1

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Keywords

  • Systematic Review
  • Knowledge Translation
  • Reporting Guideline
  • Checklist Item
  • Systematic Review Protocol

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