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PRISMA-P Group (2015) View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Explore Bristol Research Shamseer, L., Moher, D., Clarke, M., Ghersi, D., Liberati, A., Petticrew, M., ... PRISMA-P Group (2015). Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ, 349, [g7647]. DOI: 10.1136/bmj.g7647 Publisher's PDF, also known as Version of record License (if available): CC BY-NC Link to published version (if available): 10.1136/bmj.g7647 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 BMJ at http://www.bmj.com/content/349/bmj.g7647. 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/pure/about/ebr-terms.html BMJ 2014;349:g7647 doi: 10.1136/bmj.g7647 (Published 2 January 2015) Page 1 of 25 Research Methods & Reporting RESEARCH METHODS & REPORTING Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation 1 1 2 3 4 Larissa Shamseer , David Moher , Mike Clarke , Davina Ghersi , Alessandro Liberati (deceased) , 5 6 7 Mark Petticrew , Paul Shekelle , Lesley A Stewart , the PRISMA-P Group 1Ottawa Hospital Research Institute and University of Ottawa, Canada; 2Queen’s University Belfast, Ireland; 3National Health and Medical Research Council, Australia; 4University of Modena, Italy; 5London School of Hygiene and Tropical Medicine, UK; 6Southern California Evidence-based Practice Center, USA; 7Centre for Reviews and Dissemination, University of York, UK Dedication: The PRISMA-P 2015 initiative is dedicated to our colleague Introduction Alessandro Liberati (1954–2012), who passed away while PRISMA-P 2015 was under development and whose contributions to this work were Systematic reviews hold a unique place in healthcare. They help invaluable. form the basis for developing practice guidelines and they provide information on gaps in knowledge, thus informing future Abstract research efforts. This information is relevant to stakeholders Protocols of systematic reviews and meta-analyses allow for planning across the health system. The rigour and trustworthiness of and documentation of review methods, act as a guard against arbitrary systematic reviews is, in large part, based on the a priori decision making during review conduct, enable readers to assess for planning and documentation of a methodical approach to the presence of selective reporting against completed reviews, and, conduct (that is, a protocol). when made publicly available, reduce duplication of efforts and potentially A systematic review protocol is important for several reasons: prompt collaboration. Evidence documenting the existence of selective (1) it allows systematic reviewers to plan carefully and thereby reporting and excessive duplication of reviews on the same or similar anticipate potential problems; (2) it allows reviewers to explicitly topics is accumulating and many calls have been made in support of document what is planned before they start their review, the documentation and public availability of review protocols. Several enabling others to compare the protocol and the completed efforts have emerged in recent years to rectify these problems, including review (that is, to identify selective reporting), to replicate development of an international register for prospective reviews review methods if desired, and to judge the validity of planned (PROSPERO) and launch of the first open access journal dedicated to methods; (3) it prevents arbitrary decision making with respect the exclusive publication of systematic review products, including to inclusion criteria and extraction of data; and (4) it may reduce protocols (BioMed Central’s Systematic Reviews). Furthering these duplication of efforts and enhance collaboration, when available. efforts and building on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, an international Various international organizations such as the Cochrane and group of experts has created a guideline to improve the transparency, Campbell Collaborations and the Agency for Healthcare accuracy, completeness, and frequency of documented systematic Research and Quality (AHRQ) regularly require and publish review and meta-analysis protocols—PRISMA-P (for protocols) 2015. protocols. However, outside of such organizations, few protocols The PRISMA-P checklist contains 17 items considered to be essential are published in traditional journals and most reports of and minimum components of a systematic review or meta-analysis completed reviews (89%) do not mention working from a 1 protocol. protocol (2014 update under way). Many experts have called for improved documentation and availability of review protocols. This PRISMA-P 2015 Explanation and Elaboration paper provides In response, experts (some of whom are authors on this readers with a full understanding of and evidence about the necessity document) launched an international, prospective register for of each item as well as a model example from an existing published systematic review protocols (PROSPERO, www.crd.york.ac. protocol. This paper should be read together with the PRISMA-P 2015 uk/prospero/) through the Centre for Reviews and Dissemination statement. Systematic review authors and assessors are strongly at the University of York (UK) in February 2011, in which more encouraged to make use of PRISMA-P when drafting and appraising than 5000 systematic review protocols from 69 countries have review protocols. been registered as of December 2014. In February 2012, the Correspondence to: L Shamseer [email protected] For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe BMJ 2014;349:g7647 doi: 10.1136/bmj.g7647 (Published 2 January 2015) Page 2 of 25 RESEARCH METHODS & REPORTING first open access journal to exclusively publish systematic review (Standard Protocol Items: Recommendations for Interventional products including protocols (BioMed Central’s Systematic Trials) checklist items,13 and Standard 2.6 from the Institute of Reviews) was launched, in which 142 protocols have been Medicine’s Standards for Systematic Reviews.14 A detailed published (June 2014). Outside of select systematic review description of the steps undertaken during PRISMA-P organizations, little to no general guidance exists for preparing development can be found in the PRISMA-P Statement paper.15 review protocols. The process follows general recommendations of the EQUATOR (Enhancing the Quality and Transparency of health Selective reporting Research) Network on how to develop a reporting guideline, of which one fundamental part is a consensus process.16 An Arguably one of the most important functions of systematic in-person consensus meeting of international experts was held review protocols is their role as a documentation of planned in June 2011 in Rockville, MD, USA, to develop and refine review methods, outcomes, and analyses that can be compared PRISMA-P checklist items. All related guidance documents with completed reviews to detect whether unintended and have undergone iterative revision within the PRISMA-P Group undocumented changes were made. Bias related to selective listed at the end of this document; members of the PRISMA-P reporting of outcomes (that is, when reporting is related to the Group contributed to the writing and identifying relevant statistical significance or direction of effect estimate) is a examples in this document. problem in clinical research. This is a well documented 2-7 phenomenon in clinical trials, and similar findings are starting PRISMA-P checklist to emerge for systematic reviews (see item 13 for full discussion).8-10 When reviewers selectively choose which The final PRISMA-P checklist contains 17 numbered items (26 information to include in a report based on the direction and sub-items) that should be described, at minimum, in protocols significance of findings, they risk biasing the evidence base on of systematic reviews and meta-analyses (table 2⇓). The which healthcare decisions and policies are made. checklist is divided into three main sections: administrative Further to recent efforts to increase the documentation and information, introduction, and methods. Readers familiar with availability of review protocols, the next logical step is the PRISMA will observe that wording of the PRISMA-P checklists development of a set of standards that should be included in a has, where possible, been harmonized with PRISMA checklist review protocol. A well described protocol may facilitate and items, at least 13 of which are overlapping with PRISMA-P. enhance the detection of undocumented changes to review We anticipate this will aid authors in transitioning their methodology; it also may allow readers to gauge the potential systematic review protocols prepared in accordance with impact of such changes as well as selective reporting of PRISMA-P into full text, PRISMA-compliant, systematic review information on review findings. reports. To that end, a reporting guideline for systematic review protocols, an extension of the PRISMA (Preferred Items
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