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Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 Statement Moher, D., Shamseer, L., Clarke, M., Ghersi, D., Liberati, A., Petticrew, M., Shekelle, P., Stewart, L. A., & PRISMA-P Group (2015). Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Systematic Reviews, 4, [1]. https://doi.org/10.1186/2046-4053-4-1 Publisher's PDF, also known as Version of record License (if available): CC BY Link to published version (if available): 10.1186/2046-4053-4-1 Link to publication record in Explore Bristol Research PDF-document This is the final published version of the article (version of record). It first appeared online via BioMed Central at https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/2046-4053-4-1. Please refer to any applicable terms of use of the publisher. University of Bristol - Explore Bristol Research General rights This document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/red/research-policy/pure/user-guides/ebr-terms/ 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 1Ottawa 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. Moher et al. Systematic Reviews 2015, 4:1 Page 2 of 9 http://www.systematicreviewsjournal.com/content/4/1/1 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 apriori 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,
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