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The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

The PRISMA 2020 statement: an updated guideline for reporting systematic reviews Page et al. Systematic Reviews (2021) 10:89 https://doi.org/10.1186/s13643-021-01626-4 RESEARCH Open Access The PRISMA 2020 statement: an updated guideline for reporting systematic reviews 1* 1 2 3 4 Matthew J. Page , Joanne E. McKenzie , Patrick M. Bossuyt , Isabelle Boutron , Tammy C. Hoffmann , 5 6 7 8 1 9 Cynthia D. Mulrow , Larissa Shamseer , Jennifer M. Tetzlaff , Elie A. Akl , Sue E. Brennan , Roger Chou , 10 11 12 13 14 Julie Glanville , Jeremy M. Grimshaw , Asbjørn Hróbjartsson , Manoj M. Lalu , Tianjing Li , 15 16 1 17 18 Elizabeth W. Loder , Evan Mayo-Wilson , Steve McDonald , Luke A. McGuinness , Lesley A. Stewart , 19 20 21 17 22 James Thomas , Andrea C. Tricco , Vivian A. Welch , Penny Whiting and David Moher The Preferred Reporting Items for Systematic reviews and as patients, healthcare providers, researchers, and policy Meta-Analyses (PRISMA) statement, published in 2009, was makers) [1, 2]. To ensure a systematic review is valuable to designed to help systematic reviewers transparently report users, authors should prepare a transparent, complete, and why the review was done, what the authors did, and what accurate account of why the review was done, what they they found. Over the past decade, advances in systematic re- did (such as how studies were identified and selected) and view methodology and terminology have necessitated an up- what they found (such as characteristics of contributing date to the guideline. The PRISMA 2020 statement replaces studies and results of meta-analyses). Up-to-date reporting the 2009 statement and includes new reporting guidance guidance facilitates authors achieving this [3]. that reflects advances in methods to identify, select, ap- The Preferred Reporting Items for Systematic reviews praise, and synthesise studies. The structure and presenta- and Meta-Analyses (PRISMA) statement published in 2009 tion of the items have been modified to facilitate (hereafter referred to as PRISMA 2009) [4–10]is a report- implementation. In this article,wepresent thePRISMA ing guideline designed to address poor reporting of system- 2020 27-item checklist, an expanded checklist that details atic reviews [11]. The PRISMA 2009 statement comprised reporting recommendations for each item, the PRISMA a checklist of 27 items recommended for reporting in sys- 2020 abstract checklist, and the revised flow diagrams for tematic reviews and an “explanation and elaboration” paper original and updated reviews. In order to encourage its [12–16] providing additional reporting guidance for each wide dissemination this article is freely accessible on BMJ, item, along with exemplars of reporting. The recommenda- PLOS Medicine, Journal of Clinical Epidemiology and Inter- tions have been widely endorsed and adopted, as evidenced national Journal of Surgery journal websites. by its co-publication in multiple journals, citation in over Systematic reviews serve many critical roles. They can 60,000 reports (Scopus, August 2020), endorsement from provide syntheses of the state of knowledge in a field, from almost 200 journals and systematic review organisations, which future research priorities can be identified; they can and adoption in various disciplines. Evidence from observa- address questions that otherwise could not be answered by tional studies suggests that use of the PRISMA 2009 state- individual studies; they can identify problems in primary re- ment is associated with more complete reporting of search that should be rectified in future studies; and they systematic reviews [17–20], although more could be done can generate or evaluate theories about how or why phe- to improve adherence to the guideline [21]. nomena occur. Systematic reviews therefore generate vari- Many innovations in the conduct of systematic reviews ous types of knowledge for different users of reviews (such have occurred since publication of the PRISMA 2009 statement. For example, technological advances have en- abled the use of natural language processing and ma- * Correspondence: matthew.page@monash.edu chine learning to identify relevant evidence [22–24], School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia methods have been proposed to synthesise and present Full list of author information is available at the end of the article © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data. Page et al. Systematic Reviews (2021) 10:89 Page 2 of 11 findings when meta-analysis is not possible or appro- (110 of 220 invited responded). We discussed pro- priate [25–27], and new methods have been devel- posedcontent andwording of thePRISMA2020 oped to assess the risk of bias in results of included statement, as informed by the review and survey re- studies [28, 29]. Evidence on sources of bias in sys- sults, at a 21-member, two-day, in-person meeting in tematic reviews has accrued, culminating in the devel- September 2018 in Edinburgh, Scotland. Throughout opment of new tools to appraise the conduct of 2019 and 2020, we circulated an initial draft and five systematic reviews [30, 31]. Terminology used to de- revisions of the checklist and explanation and elab- scribe particular review processes has also evolved, as oration paper to co-authors for feedback. In April in the shift from assessing “quality” to assessing “cer- 2020, we invited 22 systematic reviewers who had tainty” in the body of evidence [32]. In addition, the expressed interest in providing feedback on the PRIS publishing landscape has transformed, with multiple MA 2020 checklist to share their views (via an on- avenues now available for registering and disseminat- line survey) on the layout and terminology used in a ing systematic review protocols [33, 34], disseminating preliminary version of the checklist. Feedback was reports of systematic reviews, and sharing data and received from 15 individuals and considered by the materials, such as preprint servers and publicly ac- first author, and any revisions deemed necessary cessible repositories. To capture these advances in the were incorporated before the final version was ap- reporting of systematic reviews necessitated an update proved and endorsed by all co-authors. to the PRISMA 2009 statement. The PRISMA 2020 statement Summary points Scope of the guideline • To ensure a systematic review is valuable to users, authors should prepare a transparent, complete, and accurate account of why the The PRISMA 2020 statement has been designed review was done, what they did, and what they found primarily for systematic reviews of studies that • The PRISMA 2020 statement provides updated reporting guidance for evaluate the effects of health interventions, systematic reviews that reflects advances in methods to identify, select, irrespective of the design of the included studies. appraise, and synthesise studies However, the checklist items are applicable to • The PRISMA 2020 statement consists of a 27-item checklist, an ex- reports of systematic reviews evaluating other panded checklist that details reporting recommendations for each interventions (such as social or educational item, the PRISMA 2020 abstract checklist, and revised flow diagrams for original and updated reviews interventions), and many items are applicable to • We anticipate that the PRISMA 2020 statement will benefit authors, systematic reviews with objectives other than editors, and peer reviewers of systematic reviews, and different users of evaluating interventions (such as evaluating aetiology, reviews, including guideline developers, policy makers, healthcare prevalence, or prognosis). PRISMA 2020 is intended providers, patients, and other stakeholders for use in systematic reviews that include synthesis (such as pairwise meta-analysis or other statistical synthesis methods) or do not include synthesis (for Development of PRISMA 2020 example, because only one eligible study is identi- A complete description of the methods used to fied). The PRISMA 2020 items are relevant for develop PRISMA 2020 is available elsewhere [35]. mixed-methods systematic reviews (which include We identified PRISMA 2009 items that were often quantitative and qualitative studies), but reporting reported incompletely by examining the results of guidelines addressing the presentation and synthesis studies investigating the transparency of reporting of of qualitative data should also be consulted [39, 40]. published reviews [17, 21, 36, 37]. We identified PRISMA 2020 can be used for original systematic re- possible modifications to the PRISMA 2009 views, updated systematic reviews, or continually up- statement by reviewing 60 documents providing dated (“living”) systematic reviews. However, for reporting guidance for systematic reviews (including updated and living systematic reviews, there may be reporting guidelines, handbooks, tools, and meta- some additional considerations that need to be ad- research studies) [38]. These reviews of the literature dressed. Where there is relevant content from other were used to inform the content of a survey with reporting guidelines, we reference these guidelines suggested possible modifications to the 27 items in within the items in the explanation and elaboration PRISMA 2009 and possible additional items. Respon- paper [41] (such as PRISMA-Search [42]initems 6 dents were asked whether they believed we should and 7, Synthesis without meta-analysis (SWiM) keep each PRISMA 2009 item as is, modify it, or re- reporting guideline [27] in item 13d). Box 1 includes move it, and whether we should add each additional a glossary of terms used throughout the PRISMA item. Systematic review methodologists and journal 2020 statement. editors were invited to complete the online survey Page et al. Systematic Reviews (2021) 10:89 Page 3 of 11 Box 1 Glossary of terms Systematic review—A review that uses explicit, systematic methods to collate and synthesise findings of studies that address a clearly formulated question [43] Statistical synthesis—The combination of quantitative results of two or more studies. This encompasses meta-analysis of effect estimates (described below) and other methods, such as combining P values, calculating the range and distribution of observed effects, and vote counting based on the direction of effect (see McKenzie and Brennan [25] for a description of each method) Meta-analysis of effect estimates—A statistical technique used to synthesise results when study effect estimates and their variances are available, yielding a quantitative summary of results [25] Outcome—An event or measurement collected for participants in a study (such as quality of life, mortality) Result—The combination of a point estimate (such as a mean difference, risk ratio, or proportion) and a measure of its precision (such as a confidence/credible interval) for a particular outcome Report—A document (paper or electronic) supplying information about a particular study. It could be a journal article, preprint, conference abstract, study register entry, clinical study report, dissertation, unpublished manuscript, government report, or any other document providing relevant information Record—The title or abstract (or both) of a report indexed in a database or website (such as a title or abstract for an article indexed in Medline). Records that refer to the same report (such as the same journal article) are “duplicates”; however, records that refer to reports that are merely similar (such as a similar abstract submitted to two different conferences) should be considered unique. Study—An investigation, such as a clinical trial, that includes a defined group of participants and one or more interventions and outcomes. A “study” might have multiple reports. For example, reports could include the protocol, statistical analysis plan, baseline characteristics, results for the primary outcome, results for harms, results for secondary outcomes, and results for additional mediator and moderator analyses PRISMA 2020 is not intended to guide systematic statement. The PRISMA 2020 checklist includes seven review conduct, for which comprehensive resources are sections with 27 items, some of which include sub- available [43–46]. However, familiarity with PRISMA 2020 items (Table 1). A checklist for journal and confer- is useful when planning and conducting systematic ence abstracts for systematic reviews is included in reviews to ensure that all recommended information is PRISMA 2020. This abstract checklist is an update of captured. PRISMA 2020 should not be used to assess the the 2013 PRISMA for Abstracts statement [54], conduct or methodological quality of systematic reviews; reflecting new and modified content in PRISMA 2020 other tools exist for this purpose [30, 31]. Furthermore, (Table 2). A template PRISMA flow diagram is pro- PRISMA 2020 is not intended to inform the reporting of vided, which can be modified depending on whether systematic review protocols, for which a separate the systematic review is original or updated (Fig. 1). statement is available (PRISMA for Protocols (PRISMA-P) We recommend authors refer to PRISMA 2020 early 2015 statement [47, 48]). Finally, extensions to the PRIS in the writing process, because prospective consideration MA 2009 statement have been developed to guide of the items may help to ensure that all the items are reporting of network meta-analyses [49], meta-analyses of addressed. To help keep track of which items have been individual participant data [50], systematic reviews of reported, the PRISMA statement website (http://www. harms [51], systematic reviews of diagnostic test accuracy prisma-statement.org/) includes fillable templates of the studies [52], and scoping reviews [53]; for these types of checklists to download and complete (also available in reviews we recommend authors report their review in ac- Additional file 1). We have also created a web cordance with the recommendations in PRISMA 2020 application that allows users to complete the checklist along with the guidance specific to the extension. via a user-friendly interface [58] (available at https:// prisma.shinyapps.io/checklist/ and adapted from the Transparency Checklist app [59]). The completed check- How to use PRISMA 2020 list can be exported to Word or PDF. Editable templates The PRISMA 2020 statement (including the of the flow diagram can also be downloaded from the checklists, explanation and elaboration, and flow PRISMA statement website. diagram) replaces the PRISMA 2009 statement, which We have prepared an updated explanation and should no longer be used. Box 2 summarises elaboration paper, in which we explain why reporting noteworthy changes from the PRISMA 2009 of each item is recommended and present bullet Page et al. Systematic Reviews (2021) 10:89 Page 4 of 11 Box 2 Noteworthy changes to the PRISMA 2009 statement • Inclusion of the abstract reporting checklist within PRISMA 2020 (see item #2 and Box 2). • Movement of the ‘Protocol and registration’ item from the start of the Methods section of the checklist to a new Other section, with addition of a sub-item recommending authors describe amendments to information provided at registration or in the protocol (see item #24a-24c). • Modification of the ‘Search’ item to recommend authors present full search strategies for all databases, registers and websites searched, not just at least one database (see item #7). • Modification of the ‘Study selection’ item in the Methods section to emphasise the reporting of how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process (see item #8). • Addition of a sub-item to the ‘Data items’ item recommending authors report how outcomes were defined, which results were sought, and methods for selecting a subset of results from included studies (see item #10a). • Splitting of the ‘Synthesis of results’ item in the Methods section into six sub-items recommending authors describe: the processes used to decide which studies were eligible for each synthesis; any methods required to prepare the data for synthesis; any methods used to tabulate or visually display results of individual studies and syntheses; any methods used to synthesise results; any methods used to explore possible causes of heterogeneity among study results (such as subgroup analysis, meta-regression); and any sensitivity analyses used to assess robustness of the synthesised results (see item #13a-13f). • Addition of a sub-item to the ‘Study selection’ item in the Results section recommending authors cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded (see item #16b). • Splitting of the ‘Synthesis of results’ item in the Results section into four sub-items recommending authors: briefly summarise the characteristics and risk of bias among studies contributing to the synthesis; present results of all statistical syntheses conducted; present results of any investigations of possible causes of heterogeneity among study results; and present results of any sensitivity analyses (see item #20a-20d). • Addition of new items recommending authors report methods for and results of an assessment of certainty (or confidence) in the body of evidence for an outcome (see items #15 and #22). • Addition of a new item recommending authors declare any competing interests (see item #26). • Addition of a new item recommending authors indicate whether data, analytic code and other materials used in the review are publicly available and if so, where they can be found (see item #27). points that detail the reporting recommendations provides free and permanent access to the material (which we refer to as elements) [41]. The bullet-point (such as Open Science Framework, Dryad, figshare). structure is new to PRISMA 2020 and has been A reference or link to the additional information adopted to facilitate implementation of the guidance should be included in the main report. Finally, al- [60, 61]. An expanded checklist, which comprises an though PRISMA 2020 provides a template for where abridged version of the elements presented in the ex- information might be located, the suggested location planation and elaboration paper, with references and should not be seen as prescriptive; the guiding some examples removed, is available in Additional file principle is to ensure the information is reported. 2. Consulting the explanation and elaboration paper is recommended if further clarity or information is Discussion required. Use of PRISMA 2020 has the potential to benefit many Journals and publishers might impose word and stakeholders. Complete reporting allows readers to section limits, and limits on the number of tables and assess the appropriateness of the methods, and therefore figures allowed in the main report. In such cases, if the trustworthiness of the findings. Presenting and the relevant information for some items already summarising characteristics of studies contributing to a appears in a publicly accessible review protocol, synthesis allows healthcare providers and policy makers referring to the protocol may suffice. Alternatively, to evaluate the applicability of the findings to their placing detailed descriptions of the methods used or setting. Describing the certainty in the body of evidence additional results (such as for less critical outcomes) for an outcome and the implications of findings should in supplementary files is recommended. Ideally, help policy makers, managers, and other decision supplementary files should be deposited to a general- makers formulate appropriate recommendations for purpose or institutional open-access repository that practice or policy. Complete reporting of all PRISMA Page et al. Systematic Reviews (2021) 10:89 Page 5 of 11 Table 1 PRISMA 2020 item checklist Section and topic Item # Checklist item Location where item is reported Title Title 1 Identify the report as a systematic review. Abstract Abstract 2 See the PRISMA 2020 for Abstracts checklist (Table 2). Introduction Rationale 3 Describe the rationale for the review in the context of existing knowledge. Objectives 4 Provide an explicit statement of the objective(s) or question(s) the review addresses. Methods Eligibility criteria 5 Specify the inclusion and exclusion criteria for the review and how studies were grouped for the syntheses. Information sources 6 Specify all databases, registers, websites, organisations, reference lists and other sources searched or consulted to identify studies. Specify the date when each source was last searched or consulted. Search strategy 7 Present the full search strategies for all databases, registers and websites, including any filters and limits used. Selection process 8 Specify the methods used to decide whether a study met the inclusion criteria of the review, including how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process. Data collection process 9 Specify the methods used to collect data from reports, including how many reviewers collected data from each report, whether they worked independently, any processes for obtaining or confirming data from study investigators, and if applicable, details of automation tools used in the process. Data items 10a List and define all outcomes for which data were sought. Specify whether all results that were compatible with each outcome domain in each study were sought (e.g. for all measures, time points, analyses), and if not, the methods used to decide which results to collect. 10b List and define all other variables for which data were sought (e.g. participant and intervention characteristics, funding sources). Describe any assumptions made about any missing or unclear information. Study risk of bias 11 Specify the methods used to assess risk of bias in the included studies, including details of assessment the tool(s) used, how many reviewers assessed each study and whether they worked independently, and if applicable, details of automation tools used in the process. Effect measures 12 Specify for each outcome the effect measure(s) (e.g. risk ratio, mean difference) used in the synthesis or presentation of results. Synthesis methods 13a Describe the processes used to decide which studies were eligible for each synthesis (e.g. tabulating the study intervention characteristics and comparing against the planned groups for each synthesis (item #5)). 13b Describe any methods required to prepare the data for presentation or synthesis, such as handling of missing summary statistics, or data conversions. 13c Describe any methods used to tabulate or visually display results of individual studies and syntheses. 13d Describe any methods used to synthesise results and provide a rationale for the choice(s). If meta-analysis was performed, describe the model(s), method(s) to identify the presence and extent of statistical heterogeneity, and software package(s) used. 13e Describe any methods used to explore possible causes of heterogeneity among study results (e.g. subgroup analysis, meta-regression). 13f Describe any sensitivity analyses conducted to assess robustness of the synthesised results. Reporting bias 14 Describe any methods used to assess risk of bias due to missing results in a synthesis (arising assessment from reporting biases). Certainty assessment 15 Describe any methods used to assess certainty (or confidence) in the body of evidence for an outcome. Page et al. Systematic Reviews (2021) 10:89 Page 6 of 11 Table 1 PRISMA 2020 item checklist (Continued) Section and topic Item # Checklist item Location where item is reported Results Study selection 16a Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram (see Fig. 1). 16b Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded. Study characteristics 17 Cite each included study and present its characteristics. Risk of bias in studies 18 Present assessments of risk of bias for each included study. Results of individual 19 For all outcomes, present, for each study: (a) summary statistics for each group (where studies appropriate) and (b) an effect estimate and its precision (e.g. confidence/credible interval), ideally using structured tables or plots. Results of syntheses 20a For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies. 20b Present results of all statistical syntheses conducted. If meta-analysis was done, present for each the summary estimate and its precision (e.g. confidence/credible interval) and measures of statistical heterogeneity. If comparing groups, describe the direction of the effect. 20c Present results of all investigations of possible causes of heterogeneity among study results. 20d Present results of all sensitivity analyses conducted to assess the robustness of the synthesised results. Reporting biases 21 Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed. Certainty of evidence 22 Present assessments of certainty (or confidence) in the body of evidence for each outcome assessed. Discussion Discussion 23a Provide a general interpretation of the results in the context of other evidence. 23b Discuss any limitations of the evidence included in the review. 23c Discuss any limitations of the review processes used. 23d Discuss implications of the results for practice, policy, and future research. Other information Registration and protocol 24a Provide registration information for the review, including register name and registration number, or state that the review was not registered. 24b Indicate where the review protocol can be accessed, or state that a protocol was not prepared. 24c Describe and explain any amendments to information provided at registration or in the protocol. Support 25 Describe sources of financial or non-financial support for the review, and the role of the fun- ders or sponsors in the review. Competing interests 26 Declare any competing interests of review authors. Availability of data, code, 27 Report which of the following are publicly available and where they can be found: template and other materials data collection forms; data extracted from included studies; data used for all analyses; analytic code; any other materials used in the review. 2020 items also facilitates replication and review other documents providing guidance for systematic updates, as well as inclusion of systematic reviews in reviews [38], surveyed systematic review methodologists overviews (of systematic reviews) and guidelines, so and journal editors for their views on how to revise the teams can leverage work that is already done and original PRISMA statement [35], discussed the findings decrease research waste [36, 62, 63]. at an in-person meeting, and prepared this document We updated the PRISMA 2009 statement by adapting through an iterative process. Our recommendations are the EQUATOR Network’s guidance for developing informed by the reviews and survey conducted before health research reporting guidelines [64]. We evaluated the in-person meeting, theoretical considerations about the reporting completeness of published systematic which items facilitate replication and help users assess reviews [17, 21, 36, 37], reviewed the items included in the risk of bias and applicability of systematic reviews, Page et al. Systematic Reviews (2021) 10:89 Page 7 of 11 Table 2 PRISMA 2020 for abstracts checklist Section and topic Item # Checklist item Title Title 1 Identify the report as a systematic review. Background Objectives 2 Provide an explicit statement of the main objective(s) or question(s) the review addresses. Methods Eligibility criteria 3 Specify the inclusion and exclusion criteria for the review. Information sources 4 Specify the information sources (e.g. databases, registers) used to identify studies and the date when each was last searched. Risk of bias 5 Specify the methods used to assess risk of bias in the included studies. Synthesis of results 6 Specify the methods used to present and synthesise results. Results Included studies 7 Give the total number of included studies and participants and summarise relevant characteristics of studies. Synthesis of results 8 Present results for main outcomes, preferably indicating the number of included studies and participants for each. If meta-analysis was done, report the summary estimate and confidence/credible interval. If comparing groups, indicate the direction of the effect (i.e. which group is favoured). Discussion Limitations of evidence 9 Provide a brief summary of the limitations of the evidence included in the review (e.g. study risk of bias, inconsistency and imprecision). Interpretation 10 Provide a general interpretation of the results and important implications. Other Funding 11 Specify the primary source of funding for the review. Registration 12 Provide the register name and registration number. This abstract checklist retains the same items as those included in the PRISMA for Abstracts statement published in 2013 [54], but has been revised to make the wording consistent with the PRISMA 2020 statement and includes a new item recommending authors specify the methods used to present and synthesise results (item #6) and co-authors’ experience with authoring and using peer reviewers, designing interventions that address the systematic reviews. identified barriers, and evaluating those interventions Various strategies to increase the use of reporting using randomised trials. To inform possible revisions to guidelines and improve reporting have been proposed. the guideline, it would also be valuable to conduct They include educators introducing reporting guidelines think-aloud studies [70] to understand how systematic into graduate curricula to promote good reporting reviewers interpret the items, and reliability studies to habits of early career scientists [65]; journal editors and identify items where there is varied interpretation of the regulators endorsing use of reporting guidelines [18]; items. peer reviewers evaluating adherence to reporting We encourage readers to submit evidence that informs guidelines [61, 66]; journals requiring authors to indicate any of the recommendations in PRISMA 2020 (via the PRIS where in their manuscript they have adhered to each MA statement website: http://www.prisma-statement.org/). reporting item [67]; and authors using online writing To enhance accessibility of PRISMA 2020, several tools that prompt complete reporting at the writing translations of the guideline are under way (see stage [60]. Multi-pronged interventions, where more available translations at the PRISMA statement than one of these strategies are combined, may be more website). We encourage journal editors and publishers effective (such as completion of checklists coupled with to raise awareness of PRISMA 2020 (for example, by editorial checks) [68]. However, of 31 interventions pro- referring to it in journal “Instructions to authors”), posed to increase adherence to reporting guidelines, the endorsing its use, advising editors and peer reviewers effects of only 11 have been evaluated, mostly in obser- to evaluate submitted systematic reviews against the vational studies at high risk of bias due to confounding PRISMA 2020 checklists, and making changes to [69]. It is therefore unclear which strategies should be journal policies to accommodate the new reporting used. Future research might explore barriers and facilita- recommendations. We recommend existing PRISMA tors to the use of PRISMA 2020 by authors, editors, and extensions [47, 49–53, 71, 72] be updated to reflect Page et al. Systematic Reviews (2021) 10:89 Page 8 of 11 Fig. 1 PRISMA 2020 flow diagram template for systematic reviews. The new design is adapted from flow diagrams proposed by Boers [55], Mayo-Wilson et al. [56] and Stovold et al. [57] The boxes in grey should only be completed if applicable; otherwise they should be removed from the flow diagram. Note that a “report” could be a journal article, preprint, conference abstract, study register entry, clinical study report, dissertation, unpublished manuscript, government report or any other document providing relevant information PRISMA 2020 and advise developers of new PRISMA Haddaway, Julian PT Higgins, Sally Hopewell, Brian Hutton, Jamie J Kirkham, Jos Kleijnen, Julia Koricheva, Joey SW Kwong, Toby J Lasserson, Julia H Littell, extensions to use PRISMA 2020 as the foundation Yoon K Loke, Malcolm R Macleod, Chris G Maher, Ana Marušic, Dimitris Mavri- document. dis, Jessie McGowan, Matthew DF McInnes, Philippa Middleton, Karel G Moons, Zachary Munn, Jane Noyes, Barbara Nußbaumer-Streit, Donald L Pat- rick, Tatiana Pereira-Cenci, Ba′ Pham, Bob Phillips, Dawid Pieper, Michelle Pol- Conclusion lock, Daniel S Quintana, Drummond Rennie, Melissa L Rethlefsen, Hannah R We anticipate that the PRISMA 2020 statement will Rothstein, Maroeska M Rovers, Rebecca Ryan, Georgia Salanti, Ian J Saldanha, Margaret Sampson, Nancy Santesso, Rafael Sarkis-Onofre, Jelena Savović, benefit authors, editors, and peer reviewers of systematic Christopher H Schmid, Kenneth F Schulz, Guido Schwarzer, Beverley J Shea, reviews, and different users of reviews, including Paul G Shekelle, Farhad Shokraneh, Mark Simmonds, Nicole Skoetz, Sharon E guideline developers, policy makers, healthcare Straus, Anneliese Synnot, Emily E Tanner-Smith, Brett D Thombs, Hilary Thom- son, Alexander Tsertsvadze, Peter Tugwell, Tari Turner, Lesley Uttley, Jeffrey C providers, patients, and other stakeholders. Ultimately, Valentine, Matt Vassar, Areti Angeliki Veroniki, Meera Viswanathan, Cole Way- we hope that uptake of the guideline will lead to more ant, Paul Whaley, and Kehu Yang. We thank the following contributors who transparent, complete, and accurate reporting of provided feedback on a preliminary version of the PRISMA 2020 checklist: Jo Abbott, Fionn Büttner, Patricia Correia-Santos, Victoria Freeman, Emily A Hen- systematic reviews, thus facilitating evidence based nessy, Rakibul Islam, Amalia (Emily) Karahalios, Kasper Krommes, Andreas decision making. Lundh, Dafne Port Nascimento, Davina Robson, Catherine Schenck-Yglesias, Mary M Scott, Sarah Tanveer and Pavel Zhelnov. We thank Abigail H Goben, Melissa L Rethlefsen, Tanja Rombey, Anna Scott, and Farhad Shokraneh for Supplementary Information their helpful comments on the preprints of the PRISMA 2020 papers. We The online version contains supplementary material available at https://doi. thank Edoardo Aromataris, Stephanie Chang, Toby Lasserson and David org/10.1186/s13643-021-01626-4. Schriger for their helpful peer review comments on the PRISMA 2020 papers. Additional file 1. PRISMA 2020 checklist. Provenance and peer review Additional file 2. PRISMA 2020 expanded checklist. Not commissioned; externally peer reviewed. Patient and public involvement Acknowledgements Patients and the public were not involved in this methodological research. We dedicate this paper to the late Douglas G Altman and Alessandro We plan to disseminate the research widely, including to community Liberati, whose contributions were fundamental to the development and participants in evidence synthesis organisations. implementation of the original PRISMA statement. We thank the following contributors who completed the survey to inform discussions at the development meeting: Xavier Armoiry, Edoardo Authors’ contributions Aromataris, Ana Patricia Ayala, Ethan M Balk, Virginia Barbour, Elaine Beller, JEM and DM are joint senior authors. MJP, JEM, PMB, IB, TCH, CDM, LS, and Jesse A Berlin, Lisa Bero, Zhao-Xiang Bian, Jean Joel Bigna, Ferrán Catalá- DM conceived this paper and designed the literature review and survey López, Anna Chaimani, Mike Clarke, Tammy Clifford, Ioana A Cristea, Miranda conducted to inform the guideline content. MJP conducted the literature Cumpston, Sofia Dias, Corinna Dressler, Ivan D Florez, Joel J Gagnier, Chan- review, administered the survey and analysed the data for both. MJP telle Garritty, Long Ge, Davina Ghersi, Sean Grant, Gordon Guyatt, Neal R prepared all materials for the development meeting. MJP and JEM presented Page et al. Systematic Reviews (2021) 10:89 Page 9 of 11 proposals at the development meeting. All authors except for TCH, JMT, EAA, USA. York Health Economics Consortium (YHEC Ltd), University of York, SEB, and LAM attended the development meeting. MJP and JEM took and York, UK. Clinical Epidemiology Program, Ottawa Hospital Research consolidated notes from the development meeting. MJP and JEM led the Institute, Ottawa, Canada; School of Epidemiology and Public Health, drafting and editing of the article. JEM, PMB, IB, TCH, LS, JMT, EAA, SEB, RC, University of Ottawa, Ottawa, Canada; Department of Medicine, University of JG, AH, TL, EMW, SM, LAM, LAS, JT, ACT, PW, and DM drafted particular Ottawa, Ottawa, Canada. Centre for Evidence-Based Medicine Odense sections of the article. All authors were involved in revising the article (CEBMO) and Cochrane Denmark, Department of Clinical Research, University critically for important intellectual content. All authors approved the final of Southern Denmark, JB Winsløwsvej 9b, 3rd Floor, 5000 Odense, Denmark; version of the article. MJP is the guarantor of this work. The corresponding Open Patient data Exploratory Network (OPEN), Odense University Hospital, author attests that all listed authors meet authorship criteria and that no Odense, Denmark. Department of Anesthesiology and Pain Medicine, The others meeting the criteria have been omitted. Ottawa Hospital, Ottawa, Canada; Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Canada; Regenerative Medicine Program, Ottawa Hospital Research Institute, Funding Ottawa, Canada. Department of Ophthalmology, School of Medicine, There was no direct funding for this research. MJP is supported by an University of Colorado Denver, Denver, Colorado, United States; Department Australian Research Council Discovery Early Career Researcher Award of Epidemiology, Johns Hopkins Bloomberg School of Public Health, (DE200101618) and was previously supported by an Australian National Baltimore, Maryland, USA. Division of Headache, Department of Neurology, Health and Medical Research Council (NHMRC) Early Career Fellowship Brigham and Women’s Hospital, Harvard Medical School, Boston, (1088535) during the conduct of this research. JEM is supported by an Massachusetts, USA; Head of Research, The BMJ, London, UK. Department Australian NHMRC Career Development Fellowship (1143429). TCH is of Epidemiology and Biostatistics, Indiana University School of Public supported by an Australian NHMRC Senior Research Fellowship (1154607). Health-Bloomington, Bloomington, Indiana, USA. Population Health JMT is supported by Evidence Partners Inc. JMG is supported by a Tier 1 Sciences, Bristol Medical School, University of Bristol, Bristol, UK. Centre for Canada Research Chair in Health Knowledge Transfer and Uptake. MML is Reviews and Dissemination, University of York, York, UK. EPPI-Centre, UCL supported by The Ottawa Hospital Anaesthesia Alternate Funds Association Social Research Institute, University College London, London, UK. Li Ka and a Faculty of Medicine Junior Research Chair. TL is supported by funding Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, from the National Eye Institute (UG1EY020522), National Institutes of Health, Toronto, Canada; Epidemiology Division of the Dalla Lana School of Public United States. LAM is supported by a National Institute for Health Research Health and the Institute of Health Management, Policy, and Evaluation, Doctoral Research Fellowship (DRF-2018-11-ST2–048). ACT is supported by a University of Toronto, Toronto, Canada; Queen’s Collaboration for Health Tier 2 Canada Research Chair in Knowledge Synthesis. DM is supported in Care Quality Joanna Briggs Institute Centre of Excellence, Queen’s University, part by a University Research Chair, University of Ottawa. The funders had no Kingston, Canada. Methods Centre, Bruyère Research Institute, Ottawa, role in considering the study design or in the collection, analysis, Ontario, Canada; School of Epidemiology and Public Health, Faculty of interpretation of data, writing of the report, or decision to submit the article Medicine, University of Ottawa, Ottawa, Canada. Centre for Journalology, for publication. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada; School of Epidemiology and Public Health, Faculty of Medicine, Declarations University of Ottawa, Ottawa, Canada. Competing interests Accepted: 4 January 2021 All authors have completed the ICMJE uniform disclosure form at http:// www.icmje.org/conflicts-of-interest/ and declare: EL is head of research for the BMJ; MJP is an editorial board member for PLOS Medicine; ACT is an associate editor and MJP, TL, EMW, and DM are editorial board members for References the Journal of Clinical Epidemiology; DM and LAS were editors in chief, LS, 1. Gurevitch J, Koricheva J, Nakagawa S, Stewart G. Meta-analysis and the JMT, and ACT are associate editors, and JG is an editorial board member for science of research synthesis. Nature. 2018;555:175–82. https://doi.org/10.1 Systematic Reviews. None of these authors were involved in the peer review 038/nature25753. process or decision to publish. TCH has received personal fees from Elsevier 2. Gough D, Thomas J, Oliver S. Clarifying differences between reviews within outside the submitted work. EMW has received personal fees from the evidence ecosystems. Syst Rev. 2019;8:170. https://doi.org/10.1186/s13643- American Journal for Public Health, for which he is the editor for systematic 019-1089-2. reviews. VW is editor in chief of the Campbell Collaboration, which produces 3. Moher D. Reporting guidelines: doing better for readers. BMC Med. 2018;16: systematic reviews, and co-convenor of the Campbell and Cochrane equity 233. https://doi.org/10.1186/s12916-018-1226-0. methods group. DM is chair of the EQUATOR Network, IB is adjunct director 4. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred of the French EQUATOR Centre and TCH is co-director of the Australasian reporting items for systematic reviews and meta-analyses: the PRISMA EQUATOR Centre, which advocates for the use of reporting guidelines to im- statement. Ann Intern Med. 2009;151:264–9, W64. https://doi.org/10.7326/ prove the quality of reporting in research articles. JMT received salary from 0003-4819-151-4-200908180-00135. Evidence Partners, creator of DistillerSR software for systematic reviews; Evi- 5. Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group Preferred dence Partners was not involved in the design or outcomes of the state- reporting items for systematic reviews and meta-analyses: the PRISMA ment, and the views expressed solely represent those of the author. statement. BMJ. 2009;339:b2535. https://doi.org/10.1136/bmj.b2535. 6. Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group Preferred Author details reporting items for systematic reviews and meta-analyses: the PRISMA School of Public Health and Preventive Medicine, Monash University, statement. PLoS Med. 2009;6:e1000097. https://doi.org/10.1371/journal. Melbourne, Australia. Department of Clinical Epidemiology, Biostatistics and pmed.1000097. Bioinformatics, Amsterdam University Medical Centres, University of 7. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred Amsterdam, Amsterdam, Netherlands. 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Abstract

Page et al. Systematic Reviews (2021) 10:89 https://doi.org/10.1186/s13643-021-01626-4 RESEARCH Open Access The PRISMA 2020 statement: an updated guideline for reporting systematic reviews 1* 1 2 3 4 Matthew J. Page , Joanne E. McKenzie , Patrick M. Bossuyt , Isabelle Boutron , Tammy C. Hoffmann , 5 6 7 8 1 9 Cynthia D. Mulrow , Larissa Shamseer , Jennifer M. Tetzlaff , Elie A. Akl , Sue E. Brennan , Roger Chou , 10 11 12 13 14 Julie Glanville , Jeremy M. Grimshaw , Asbjørn Hróbjartsson , Manoj M. Lalu , Tianjing Li , 15 16 1 17 18 Elizabeth W. Loder , Evan Mayo-Wilson , Steve McDonald , Luke A. McGuinness , Lesley A. Stewart , 19 20 21 17 22 James Thomas , Andrea C. Tricco , Vivian A. Welch , Penny Whiting and David Moher The Preferred Reporting Items for Systematic reviews and as patients, healthcare providers, researchers, and policy Meta-Analyses (PRISMA) statement, published in 2009, was makers) [1, 2]. To ensure a systematic review is valuable to designed to help systematic reviewers transparently report users, authors should prepare a transparent, complete, and why the review was done, what the authors did, and what accurate account of why the review was done, what they they found. Over the past decade, advances in systematic re- did (such as how studies were identified and selected) and view methodology and terminology have necessitated an up- what they found (such as characteristics of contributing date to the guideline. The PRISMA 2020 statement replaces studies and results of meta-analyses). Up-to-date reporting the 2009 statement and includes new reporting guidance guidance facilitates authors achieving this [3]. that reflects advances in methods to identify, select, ap- The Preferred Reporting Items for Systematic reviews praise, and synthesise studies. The structure and presenta- and Meta-Analyses (PRISMA) statement published in 2009 tion of the items have been modified to facilitate (hereafter referred to as PRISMA 2009) [4–10]is a report- implementation. In this article,wepresent thePRISMA ing guideline designed to address poor reporting of system- 2020 27-item checklist, an expanded checklist that details atic reviews [11]. The PRISMA 2009 statement comprised reporting recommendations for each item, the PRISMA a checklist of 27 items recommended for reporting in sys- 2020 abstract checklist, and the revised flow diagrams for tematic reviews and an “explanation and elaboration” paper original and updated reviews. In order to encourage its [12–16] providing additional reporting guidance for each wide dissemination this article is freely accessible on BMJ, item, along with exemplars of reporting. The recommenda- PLOS Medicine, Journal of Clinical Epidemiology and Inter- tions have been widely endorsed and adopted, as evidenced national Journal of Surgery journal websites. by its co-publication in multiple journals, citation in over Systematic reviews serve many critical roles. They can 60,000 reports (Scopus, August 2020), endorsement from provide syntheses of the state of knowledge in a field, from almost 200 journals and systematic review organisations, which future research priorities can be identified; they can and adoption in various disciplines. Evidence from observa- address questions that otherwise could not be answered by tional studies suggests that use of the PRISMA 2009 state- individual studies; they can identify problems in primary re- ment is associated with more complete reporting of search that should be rectified in future studies; and they systematic reviews [17–20], although more could be done can generate or evaluate theories about how or why phe- to improve adherence to the guideline [21]. nomena occur. Systematic reviews therefore generate vari- Many innovations in the conduct of systematic reviews ous types of knowledge for different users of reviews (such have occurred since publication of the PRISMA 2009 statement. For example, technological advances have en- abled the use of natural language processing and ma- * Correspondence: matthew.page@monash.edu chine learning to identify relevant evidence [22–24], School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia methods have been proposed to synthesise and present Full list of author information is available at the end of the article © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data. Page et al. Systematic Reviews (2021) 10:89 Page 2 of 11 findings when meta-analysis is not possible or appro- (110 of 220 invited responded). We discussed pro- priate [25–27], and new methods have been devel- posedcontent andwording of thePRISMA2020 oped to assess the risk of bias in results of included statement, as informed by the review and survey re- studies [28, 29]. Evidence on sources of bias in sys- sults, at a 21-member, two-day, in-person meeting in tematic reviews has accrued, culminating in the devel- September 2018 in Edinburgh, Scotland. Throughout opment of new tools to appraise the conduct of 2019 and 2020, we circulated an initial draft and five systematic reviews [30, 31]. Terminology used to de- revisions of the checklist and explanation and elab- scribe particular review processes has also evolved, as oration paper to co-authors for feedback. In April in the shift from assessing “quality” to assessing “cer- 2020, we invited 22 systematic reviewers who had tainty” in the body of evidence [32]. In addition, the expressed interest in providing feedback on the PRIS publishing landscape has transformed, with multiple MA 2020 checklist to share their views (via an on- avenues now available for registering and disseminat- line survey) on the layout and terminology used in a ing systematic review protocols [33, 34], disseminating preliminary version of the checklist. Feedback was reports of systematic reviews, and sharing data and received from 15 individuals and considered by the materials, such as preprint servers and publicly ac- first author, and any revisions deemed necessary cessible repositories. To capture these advances in the were incorporated before the final version was ap- reporting of systematic reviews necessitated an update proved and endorsed by all co-authors. to the PRISMA 2009 statement. The PRISMA 2020 statement Summary points Scope of the guideline • To ensure a systematic review is valuable to users, authors should prepare a transparent, complete, and accurate account of why the The PRISMA 2020 statement has been designed review was done, what they did, and what they found primarily for systematic reviews of studies that • The PRISMA 2020 statement provides updated reporting guidance for evaluate the effects of health interventions, systematic reviews that reflects advances in methods to identify, select, irrespective of the design of the included studies. appraise, and synthesise studies However, the checklist items are applicable to • The PRISMA 2020 statement consists of a 27-item checklist, an ex- reports of systematic reviews evaluating other panded checklist that details reporting recommendations for each interventions (such as social or educational item, the PRISMA 2020 abstract checklist, and revised flow diagrams for original and updated reviews interventions), and many items are applicable to • We anticipate that the PRISMA 2020 statement will benefit authors, systematic reviews with objectives other than editors, and peer reviewers of systematic reviews, and different users of evaluating interventions (such as evaluating aetiology, reviews, including guideline developers, policy makers, healthcare prevalence, or prognosis). PRISMA 2020 is intended providers, patients, and other stakeholders for use in systematic reviews that include synthesis (such as pairwise meta-analysis or other statistical synthesis methods) or do not include synthesis (for Development of PRISMA 2020 example, because only one eligible study is identi- A complete description of the methods used to fied). The PRISMA 2020 items are relevant for develop PRISMA 2020 is available elsewhere [35]. mixed-methods systematic reviews (which include We identified PRISMA 2009 items that were often quantitative and qualitative studies), but reporting reported incompletely by examining the results of guidelines addressing the presentation and synthesis studies investigating the transparency of reporting of of qualitative data should also be consulted [39, 40]. published reviews [17, 21, 36, 37]. We identified PRISMA 2020 can be used for original systematic re- possible modifications to the PRISMA 2009 views, updated systematic reviews, or continually up- statement by reviewing 60 documents providing dated (“living”) systematic reviews. However, for reporting guidance for systematic reviews (including updated and living systematic reviews, there may be reporting guidelines, handbooks, tools, and meta- some additional considerations that need to be ad- research studies) [38]. These reviews of the literature dressed. Where there is relevant content from other were used to inform the content of a survey with reporting guidelines, we reference these guidelines suggested possible modifications to the 27 items in within the items in the explanation and elaboration PRISMA 2009 and possible additional items. Respon- paper [41] (such as PRISMA-Search [42]initems 6 dents were asked whether they believed we should and 7, Synthesis without meta-analysis (SWiM) keep each PRISMA 2009 item as is, modify it, or re- reporting guideline [27] in item 13d). Box 1 includes move it, and whether we should add each additional a glossary of terms used throughout the PRISMA item. Systematic review methodologists and journal 2020 statement. editors were invited to complete the online survey Page et al. Systematic Reviews (2021) 10:89 Page 3 of 11 Box 1 Glossary of terms Systematic review—A review that uses explicit, systematic methods to collate and synthesise findings of studies that address a clearly formulated question [43] Statistical synthesis—The combination of quantitative results of two or more studies. This encompasses meta-analysis of effect estimates (described below) and other methods, such as combining P values, calculating the range and distribution of observed effects, and vote counting based on the direction of effect (see McKenzie and Brennan [25] for a description of each method) Meta-analysis of effect estimates—A statistical technique used to synthesise results when study effect estimates and their variances are available, yielding a quantitative summary of results [25] Outcome—An event or measurement collected for participants in a study (such as quality of life, mortality) Result—The combination of a point estimate (such as a mean difference, risk ratio, or proportion) and a measure of its precision (such as a confidence/credible interval) for a particular outcome Report—A document (paper or electronic) supplying information about a particular study. It could be a journal article, preprint, conference abstract, study register entry, clinical study report, dissertation, unpublished manuscript, government report, or any other document providing relevant information Record—The title or abstract (or both) of a report indexed in a database or website (such as a title or abstract for an article indexed in Medline). Records that refer to the same report (such as the same journal article) are “duplicates”; however, records that refer to reports that are merely similar (such as a similar abstract submitted to two different conferences) should be considered unique. Study—An investigation, such as a clinical trial, that includes a defined group of participants and one or more interventions and outcomes. A “study” might have multiple reports. For example, reports could include the protocol, statistical analysis plan, baseline characteristics, results for the primary outcome, results for harms, results for secondary outcomes, and results for additional mediator and moderator analyses PRISMA 2020 is not intended to guide systematic statement. The PRISMA 2020 checklist includes seven review conduct, for which comprehensive resources are sections with 27 items, some of which include sub- available [43–46]. However, familiarity with PRISMA 2020 items (Table 1). A checklist for journal and confer- is useful when planning and conducting systematic ence abstracts for systematic reviews is included in reviews to ensure that all recommended information is PRISMA 2020. This abstract checklist is an update of captured. PRISMA 2020 should not be used to assess the the 2013 PRISMA for Abstracts statement [54], conduct or methodological quality of systematic reviews; reflecting new and modified content in PRISMA 2020 other tools exist for this purpose [30, 31]. Furthermore, (Table 2). A template PRISMA flow diagram is pro- PRISMA 2020 is not intended to inform the reporting of vided, which can be modified depending on whether systematic review protocols, for which a separate the systematic review is original or updated (Fig. 1). statement is available (PRISMA for Protocols (PRISMA-P) We recommend authors refer to PRISMA 2020 early 2015 statement [47, 48]). Finally, extensions to the PRIS in the writing process, because prospective consideration MA 2009 statement have been developed to guide of the items may help to ensure that all the items are reporting of network meta-analyses [49], meta-analyses of addressed. To help keep track of which items have been individual participant data [50], systematic reviews of reported, the PRISMA statement website (http://www. harms [51], systematic reviews of diagnostic test accuracy prisma-statement.org/) includes fillable templates of the studies [52], and scoping reviews [53]; for these types of checklists to download and complete (also available in reviews we recommend authors report their review in ac- Additional file 1). We have also created a web cordance with the recommendations in PRISMA 2020 application that allows users to complete the checklist along with the guidance specific to the extension. via a user-friendly interface [58] (available at https:// prisma.shinyapps.io/checklist/ and adapted from the Transparency Checklist app [59]). The completed check- How to use PRISMA 2020 list can be exported to Word or PDF. Editable templates The PRISMA 2020 statement (including the of the flow diagram can also be downloaded from the checklists, explanation and elaboration, and flow PRISMA statement website. diagram) replaces the PRISMA 2009 statement, which We have prepared an updated explanation and should no longer be used. Box 2 summarises elaboration paper, in which we explain why reporting noteworthy changes from the PRISMA 2009 of each item is recommended and present bullet Page et al. Systematic Reviews (2021) 10:89 Page 4 of 11 Box 2 Noteworthy changes to the PRISMA 2009 statement • Inclusion of the abstract reporting checklist within PRISMA 2020 (see item #2 and Box 2). • Movement of the ‘Protocol and registration’ item from the start of the Methods section of the checklist to a new Other section, with addition of a sub-item recommending authors describe amendments to information provided at registration or in the protocol (see item #24a-24c). • Modification of the ‘Search’ item to recommend authors present full search strategies for all databases, registers and websites searched, not just at least one database (see item #7). • Modification of the ‘Study selection’ item in the Methods section to emphasise the reporting of how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process (see item #8). • Addition of a sub-item to the ‘Data items’ item recommending authors report how outcomes were defined, which results were sought, and methods for selecting a subset of results from included studies (see item #10a). • Splitting of the ‘Synthesis of results’ item in the Methods section into six sub-items recommending authors describe: the processes used to decide which studies were eligible for each synthesis; any methods required to prepare the data for synthesis; any methods used to tabulate or visually display results of individual studies and syntheses; any methods used to synthesise results; any methods used to explore possible causes of heterogeneity among study results (such as subgroup analysis, meta-regression); and any sensitivity analyses used to assess robustness of the synthesised results (see item #13a-13f). • Addition of a sub-item to the ‘Study selection’ item in the Results section recommending authors cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded (see item #16b). • Splitting of the ‘Synthesis of results’ item in the Results section into four sub-items recommending authors: briefly summarise the characteristics and risk of bias among studies contributing to the synthesis; present results of all statistical syntheses conducted; present results of any investigations of possible causes of heterogeneity among study results; and present results of any sensitivity analyses (see item #20a-20d). • Addition of new items recommending authors report methods for and results of an assessment of certainty (or confidence) in the body of evidence for an outcome (see items #15 and #22). • Addition of a new item recommending authors declare any competing interests (see item #26). • Addition of a new item recommending authors indicate whether data, analytic code and other materials used in the review are publicly available and if so, where they can be found (see item #27). points that detail the reporting recommendations provides free and permanent access to the material (which we refer to as elements) [41]. The bullet-point (such as Open Science Framework, Dryad, figshare). structure is new to PRISMA 2020 and has been A reference or link to the additional information adopted to facilitate implementation of the guidance should be included in the main report. Finally, al- [60, 61]. An expanded checklist, which comprises an though PRISMA 2020 provides a template for where abridged version of the elements presented in the ex- information might be located, the suggested location planation and elaboration paper, with references and should not be seen as prescriptive; the guiding some examples removed, is available in Additional file principle is to ensure the information is reported. 2. Consulting the explanation and elaboration paper is recommended if further clarity or information is Discussion required. Use of PRISMA 2020 has the potential to benefit many Journals and publishers might impose word and stakeholders. Complete reporting allows readers to section limits, and limits on the number of tables and assess the appropriateness of the methods, and therefore figures allowed in the main report. In such cases, if the trustworthiness of the findings. Presenting and the relevant information for some items already summarising characteristics of studies contributing to a appears in a publicly accessible review protocol, synthesis allows healthcare providers and policy makers referring to the protocol may suffice. Alternatively, to evaluate the applicability of the findings to their placing detailed descriptions of the methods used or setting. Describing the certainty in the body of evidence additional results (such as for less critical outcomes) for an outcome and the implications of findings should in supplementary files is recommended. Ideally, help policy makers, managers, and other decision supplementary files should be deposited to a general- makers formulate appropriate recommendations for purpose or institutional open-access repository that practice or policy. Complete reporting of all PRISMA Page et al. Systematic Reviews (2021) 10:89 Page 5 of 11 Table 1 PRISMA 2020 item checklist Section and topic Item # Checklist item Location where item is reported Title Title 1 Identify the report as a systematic review. Abstract Abstract 2 See the PRISMA 2020 for Abstracts checklist (Table 2). Introduction Rationale 3 Describe the rationale for the review in the context of existing knowledge. Objectives 4 Provide an explicit statement of the objective(s) or question(s) the review addresses. Methods Eligibility criteria 5 Specify the inclusion and exclusion criteria for the review and how studies were grouped for the syntheses. Information sources 6 Specify all databases, registers, websites, organisations, reference lists and other sources searched or consulted to identify studies. Specify the date when each source was last searched or consulted. Search strategy 7 Present the full search strategies for all databases, registers and websites, including any filters and limits used. Selection process 8 Specify the methods used to decide whether a study met the inclusion criteria of the review, including how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process. Data collection process 9 Specify the methods used to collect data from reports, including how many reviewers collected data from each report, whether they worked independently, any processes for obtaining or confirming data from study investigators, and if applicable, details of automation tools used in the process. Data items 10a List and define all outcomes for which data were sought. Specify whether all results that were compatible with each outcome domain in each study were sought (e.g. for all measures, time points, analyses), and if not, the methods used to decide which results to collect. 10b List and define all other variables for which data were sought (e.g. participant and intervention characteristics, funding sources). Describe any assumptions made about any missing or unclear information. Study risk of bias 11 Specify the methods used to assess risk of bias in the included studies, including details of assessment the tool(s) used, how many reviewers assessed each study and whether they worked independently, and if applicable, details of automation tools used in the process. Effect measures 12 Specify for each outcome the effect measure(s) (e.g. risk ratio, mean difference) used in the synthesis or presentation of results. Synthesis methods 13a Describe the processes used to decide which studies were eligible for each synthesis (e.g. tabulating the study intervention characteristics and comparing against the planned groups for each synthesis (item #5)). 13b Describe any methods required to prepare the data for presentation or synthesis, such as handling of missing summary statistics, or data conversions. 13c Describe any methods used to tabulate or visually display results of individual studies and syntheses. 13d Describe any methods used to synthesise results and provide a rationale for the choice(s). If meta-analysis was performed, describe the model(s), method(s) to identify the presence and extent of statistical heterogeneity, and software package(s) used. 13e Describe any methods used to explore possible causes of heterogeneity among study results (e.g. subgroup analysis, meta-regression). 13f Describe any sensitivity analyses conducted to assess robustness of the synthesised results. Reporting bias 14 Describe any methods used to assess risk of bias due to missing results in a synthesis (arising assessment from reporting biases). Certainty assessment 15 Describe any methods used to assess certainty (or confidence) in the body of evidence for an outcome. Page et al. Systematic Reviews (2021) 10:89 Page 6 of 11 Table 1 PRISMA 2020 item checklist (Continued) Section and topic Item # Checklist item Location where item is reported Results Study selection 16a Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram (see Fig. 1). 16b Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded. Study characteristics 17 Cite each included study and present its characteristics. Risk of bias in studies 18 Present assessments of risk of bias for each included study. Results of individual 19 For all outcomes, present, for each study: (a) summary statistics for each group (where studies appropriate) and (b) an effect estimate and its precision (e.g. confidence/credible interval), ideally using structured tables or plots. Results of syntheses 20a For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies. 20b Present results of all statistical syntheses conducted. If meta-analysis was done, present for each the summary estimate and its precision (e.g. confidence/credible interval) and measures of statistical heterogeneity. If comparing groups, describe the direction of the effect. 20c Present results of all investigations of possible causes of heterogeneity among study results. 20d Present results of all sensitivity analyses conducted to assess the robustness of the synthesised results. Reporting biases 21 Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed. Certainty of evidence 22 Present assessments of certainty (or confidence) in the body of evidence for each outcome assessed. Discussion Discussion 23a Provide a general interpretation of the results in the context of other evidence. 23b Discuss any limitations of the evidence included in the review. 23c Discuss any limitations of the review processes used. 23d Discuss implications of the results for practice, policy, and future research. Other information Registration and protocol 24a Provide registration information for the review, including register name and registration number, or state that the review was not registered. 24b Indicate where the review protocol can be accessed, or state that a protocol was not prepared. 24c Describe and explain any amendments to information provided at registration or in the protocol. Support 25 Describe sources of financial or non-financial support for the review, and the role of the fun- ders or sponsors in the review. Competing interests 26 Declare any competing interests of review authors. Availability of data, code, 27 Report which of the following are publicly available and where they can be found: template and other materials data collection forms; data extracted from included studies; data used for all analyses; analytic code; any other materials used in the review. 2020 items also facilitates replication and review other documents providing guidance for systematic updates, as well as inclusion of systematic reviews in reviews [38], surveyed systematic review methodologists overviews (of systematic reviews) and guidelines, so and journal editors for their views on how to revise the teams can leverage work that is already done and original PRISMA statement [35], discussed the findings decrease research waste [36, 62, 63]. at an in-person meeting, and prepared this document We updated the PRISMA 2009 statement by adapting through an iterative process. Our recommendations are the EQUATOR Network’s guidance for developing informed by the reviews and survey conducted before health research reporting guidelines [64]. We evaluated the in-person meeting, theoretical considerations about the reporting completeness of published systematic which items facilitate replication and help users assess reviews [17, 21, 36, 37], reviewed the items included in the risk of bias and applicability of systematic reviews, Page et al. Systematic Reviews (2021) 10:89 Page 7 of 11 Table 2 PRISMA 2020 for abstracts checklist Section and topic Item # Checklist item Title Title 1 Identify the report as a systematic review. Background Objectives 2 Provide an explicit statement of the main objective(s) or question(s) the review addresses. Methods Eligibility criteria 3 Specify the inclusion and exclusion criteria for the review. Information sources 4 Specify the information sources (e.g. databases, registers) used to identify studies and the date when each was last searched. Risk of bias 5 Specify the methods used to assess risk of bias in the included studies. Synthesis of results 6 Specify the methods used to present and synthesise results. Results Included studies 7 Give the total number of included studies and participants and summarise relevant characteristics of studies. Synthesis of results 8 Present results for main outcomes, preferably indicating the number of included studies and participants for each. If meta-analysis was done, report the summary estimate and confidence/credible interval. If comparing groups, indicate the direction of the effect (i.e. which group is favoured). Discussion Limitations of evidence 9 Provide a brief summary of the limitations of the evidence included in the review (e.g. study risk of bias, inconsistency and imprecision). Interpretation 10 Provide a general interpretation of the results and important implications. Other Funding 11 Specify the primary source of funding for the review. Registration 12 Provide the register name and registration number. This abstract checklist retains the same items as those included in the PRISMA for Abstracts statement published in 2013 [54], but has been revised to make the wording consistent with the PRISMA 2020 statement and includes a new item recommending authors specify the methods used to present and synthesise results (item #6) and co-authors’ experience with authoring and using peer reviewers, designing interventions that address the systematic reviews. identified barriers, and evaluating those interventions Various strategies to increase the use of reporting using randomised trials. To inform possible revisions to guidelines and improve reporting have been proposed. the guideline, it would also be valuable to conduct They include educators introducing reporting guidelines think-aloud studies [70] to understand how systematic into graduate curricula to promote good reporting reviewers interpret the items, and reliability studies to habits of early career scientists [65]; journal editors and identify items where there is varied interpretation of the regulators endorsing use of reporting guidelines [18]; items. peer reviewers evaluating adherence to reporting We encourage readers to submit evidence that informs guidelines [61, 66]; journals requiring authors to indicate any of the recommendations in PRISMA 2020 (via the PRIS where in their manuscript they have adhered to each MA statement website: http://www.prisma-statement.org/). reporting item [67]; and authors using online writing To enhance accessibility of PRISMA 2020, several tools that prompt complete reporting at the writing translations of the guideline are under way (see stage [60]. Multi-pronged interventions, where more available translations at the PRISMA statement than one of these strategies are combined, may be more website). We encourage journal editors and publishers effective (such as completion of checklists coupled with to raise awareness of PRISMA 2020 (for example, by editorial checks) [68]. However, of 31 interventions pro- referring to it in journal “Instructions to authors”), posed to increase adherence to reporting guidelines, the endorsing its use, advising editors and peer reviewers effects of only 11 have been evaluated, mostly in obser- to evaluate submitted systematic reviews against the vational studies at high risk of bias due to confounding PRISMA 2020 checklists, and making changes to [69]. It is therefore unclear which strategies should be journal policies to accommodate the new reporting used. Future research might explore barriers and facilita- recommendations. We recommend existing PRISMA tors to the use of PRISMA 2020 by authors, editors, and extensions [47, 49–53, 71, 72] be updated to reflect Page et al. Systematic Reviews (2021) 10:89 Page 8 of 11 Fig. 1 PRISMA 2020 flow diagram template for systematic reviews. The new design is adapted from flow diagrams proposed by Boers [55], Mayo-Wilson et al. [56] and Stovold et al. [57] The boxes in grey should only be completed if applicable; otherwise they should be removed from the flow diagram. Note that a “report” could be a journal article, preprint, conference abstract, study register entry, clinical study report, dissertation, unpublished manuscript, government report or any other document providing relevant information PRISMA 2020 and advise developers of new PRISMA Haddaway, Julian PT Higgins, Sally Hopewell, Brian Hutton, Jamie J Kirkham, Jos Kleijnen, Julia Koricheva, Joey SW Kwong, Toby J Lasserson, Julia H Littell, extensions to use PRISMA 2020 as the foundation Yoon K Loke, Malcolm R Macleod, Chris G Maher, Ana Marušic, Dimitris Mavri- document. dis, Jessie McGowan, Matthew DF McInnes, Philippa Middleton, Karel G Moons, Zachary Munn, Jane Noyes, Barbara Nußbaumer-Streit, Donald L Pat- rick, Tatiana Pereira-Cenci, Ba′ Pham, Bob Phillips, Dawid Pieper, Michelle Pol- Conclusion lock, Daniel S Quintana, Drummond Rennie, Melissa L Rethlefsen, Hannah R We anticipate that the PRISMA 2020 statement will Rothstein, Maroeska M Rovers, Rebecca Ryan, Georgia Salanti, Ian J Saldanha, Margaret Sampson, Nancy Santesso, Rafael Sarkis-Onofre, Jelena Savović, benefit authors, editors, and peer reviewers of systematic Christopher H Schmid, Kenneth F Schulz, Guido Schwarzer, Beverley J Shea, reviews, and different users of reviews, including Paul G Shekelle, Farhad Shokraneh, Mark Simmonds, Nicole Skoetz, Sharon E guideline developers, policy makers, healthcare Straus, Anneliese Synnot, Emily E Tanner-Smith, Brett D Thombs, Hilary Thom- son, Alexander Tsertsvadze, Peter Tugwell, Tari Turner, Lesley Uttley, Jeffrey C providers, patients, and other stakeholders. Ultimately, Valentine, Matt Vassar, Areti Angeliki Veroniki, Meera Viswanathan, Cole Way- we hope that uptake of the guideline will lead to more ant, Paul Whaley, and Kehu Yang. We thank the following contributors who transparent, complete, and accurate reporting of provided feedback on a preliminary version of the PRISMA 2020 checklist: Jo Abbott, Fionn Büttner, Patricia Correia-Santos, Victoria Freeman, Emily A Hen- systematic reviews, thus facilitating evidence based nessy, Rakibul Islam, Amalia (Emily) Karahalios, Kasper Krommes, Andreas decision making. Lundh, Dafne Port Nascimento, Davina Robson, Catherine Schenck-Yglesias, Mary M Scott, Sarah Tanveer and Pavel Zhelnov. We thank Abigail H Goben, Melissa L Rethlefsen, Tanja Rombey, Anna Scott, and Farhad Shokraneh for Supplementary Information their helpful comments on the preprints of the PRISMA 2020 papers. We The online version contains supplementary material available at https://doi. thank Edoardo Aromataris, Stephanie Chang, Toby Lasserson and David org/10.1186/s13643-021-01626-4. Schriger for their helpful peer review comments on the PRISMA 2020 papers. Additional file 1. PRISMA 2020 checklist. Provenance and peer review Additional file 2. PRISMA 2020 expanded checklist. Not commissioned; externally peer reviewed. Patient and public involvement Acknowledgements Patients and the public were not involved in this methodological research. We dedicate this paper to the late Douglas G Altman and Alessandro We plan to disseminate the research widely, including to community Liberati, whose contributions were fundamental to the development and participants in evidence synthesis organisations. implementation of the original PRISMA statement. We thank the following contributors who completed the survey to inform discussions at the development meeting: Xavier Armoiry, Edoardo Authors’ contributions Aromataris, Ana Patricia Ayala, Ethan M Balk, Virginia Barbour, Elaine Beller, JEM and DM are joint senior authors. MJP, JEM, PMB, IB, TCH, CDM, LS, and Jesse A Berlin, Lisa Bero, Zhao-Xiang Bian, Jean Joel Bigna, Ferrán Catalá- DM conceived this paper and designed the literature review and survey López, Anna Chaimani, Mike Clarke, Tammy Clifford, Ioana A Cristea, Miranda conducted to inform the guideline content. MJP conducted the literature Cumpston, Sofia Dias, Corinna Dressler, Ivan D Florez, Joel J Gagnier, Chan- review, administered the survey and analysed the data for both. MJP telle Garritty, Long Ge, Davina Ghersi, Sean Grant, Gordon Guyatt, Neal R prepared all materials for the development meeting. MJP and JEM presented Page et al. Systematic Reviews (2021) 10:89 Page 9 of 11 proposals at the development meeting. All authors except for TCH, JMT, EAA, USA. York Health Economics Consortium (YHEC Ltd), University of York, SEB, and LAM attended the development meeting. MJP and JEM took and York, UK. Clinical Epidemiology Program, Ottawa Hospital Research consolidated notes from the development meeting. MJP and JEM led the Institute, Ottawa, Canada; School of Epidemiology and Public Health, drafting and editing of the article. JEM, PMB, IB, TCH, LS, JMT, EAA, SEB, RC, University of Ottawa, Ottawa, Canada; Department of Medicine, University of JG, AH, TL, EMW, SM, LAM, LAS, JT, ACT, PW, and DM drafted particular Ottawa, Ottawa, Canada. Centre for Evidence-Based Medicine Odense sections of the article. All authors were involved in revising the article (CEBMO) and Cochrane Denmark, Department of Clinical Research, University critically for important intellectual content. All authors approved the final of Southern Denmark, JB Winsløwsvej 9b, 3rd Floor, 5000 Odense, Denmark; version of the article. MJP is the guarantor of this work. The corresponding Open Patient data Exploratory Network (OPEN), Odense University Hospital, author attests that all listed authors meet authorship criteria and that no Odense, Denmark. Department of Anesthesiology and Pain Medicine, The others meeting the criteria have been omitted. Ottawa Hospital, Ottawa, Canada; Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Canada; Regenerative Medicine Program, Ottawa Hospital Research Institute, Funding Ottawa, Canada. Department of Ophthalmology, School of Medicine, There was no direct funding for this research. MJP is supported by an University of Colorado Denver, Denver, Colorado, United States; Department Australian Research Council Discovery Early Career Researcher Award of Epidemiology, Johns Hopkins Bloomberg School of Public Health, (DE200101618) and was previously supported by an Australian National Baltimore, Maryland, USA. Division of Headache, Department of Neurology, Health and Medical Research Council (NHMRC) Early Career Fellowship Brigham and Women’s Hospital, Harvard Medical School, Boston, (1088535) during the conduct of this research. JEM is supported by an Massachusetts, USA; Head of Research, The BMJ, London, UK. Department Australian NHMRC Career Development Fellowship (1143429). TCH is of Epidemiology and Biostatistics, Indiana University School of Public supported by an Australian NHMRC Senior Research Fellowship (1154607). Health-Bloomington, Bloomington, Indiana, USA. Population Health JMT is supported by Evidence Partners Inc. JMG is supported by a Tier 1 Sciences, Bristol Medical School, University of Bristol, Bristol, UK. Centre for Canada Research Chair in Health Knowledge Transfer and Uptake. MML is Reviews and Dissemination, University of York, York, UK. EPPI-Centre, UCL supported by The Ottawa Hospital Anaesthesia Alternate Funds Association Social Research Institute, University College London, London, UK. Li Ka and a Faculty of Medicine Junior Research Chair. TL is supported by funding Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, from the National Eye Institute (UG1EY020522), National Institutes of Health, Toronto, Canada; Epidemiology Division of the Dalla Lana School of Public United States. LAM is supported by a National Institute for Health Research Health and the Institute of Health Management, Policy, and Evaluation, Doctoral Research Fellowship (DRF-2018-11-ST2–048). ACT is supported by a University of Toronto, Toronto, Canada; Queen’s Collaboration for Health Tier 2 Canada Research Chair in Knowledge Synthesis. DM is supported in Care Quality Joanna Briggs Institute Centre of Excellence, Queen’s University, part by a University Research Chair, University of Ottawa. The funders had no Kingston, Canada. Methods Centre, Bruyère Research Institute, Ottawa, role in considering the study design or in the collection, analysis, Ontario, Canada; School of Epidemiology and Public Health, Faculty of interpretation of data, writing of the report, or decision to submit the article Medicine, University of Ottawa, Ottawa, Canada. Centre for Journalology, for publication. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada; School of Epidemiology and Public Health, Faculty of Medicine, Declarations University of Ottawa, Ottawa, Canada. Competing interests Accepted: 4 January 2021 All authors have completed the ICMJE uniform disclosure form at http:// www.icmje.org/conflicts-of-interest/ and declare: EL is head of research for the BMJ; MJP is an editorial board member for PLOS Medicine; ACT is an associate editor and MJP, TL, EMW, and DM are editorial board members for References the Journal of Clinical Epidemiology; DM and LAS were editors in chief, LS, 1. Gurevitch J, Koricheva J, Nakagawa S, Stewart G. Meta-analysis and the JMT, and ACT are associate editors, and JG is an editorial board member for science of research synthesis. Nature. 2018;555:175–82. https://doi.org/10.1 Systematic Reviews. None of these authors were involved in the peer review 038/nature25753. process or decision to publish. TCH has received personal fees from Elsevier 2. Gough D, Thomas J, Oliver S. Clarifying differences between reviews within outside the submitted work. EMW has received personal fees from the evidence ecosystems. 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