Search

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews. Full English text available from:www.revespcardiol.org/en.

Editor's Note: This article is a reprint of a previously published article. For citation purposes, please use the original publication details: Harris RP, Helfand M, Woolf SH, et al. Current methods of the U.S. Preventive Services Task Force: a review of the process. Am J Prev Med. 2001;20(3S):21-35. The U.S. Preventive Services Task Force (USPSTF/Task Force) represents one of several efforts to take a more evidence-based approach to the development of clinical practice guidelines. As methods have matured for assembling and reviewing evidence and for translating evidence into guidelines, so too have the methods of the USPSTF. This paper summarizes the current methods of the third USPSTF, supported by the Agency for Healthcare Research and Quality (AHRQ) and two of the AHRQ Evidence-based Practice Centers (EPCs). The Task Force limits the topics it reviews to those conditions that cause a large burden of suffering to society and that also have available a potentially effective preventive service. It focuses its reviews on the questions and evidence most critical to making a recommendation. It uses analytic frameworks to specify the linkages and key questions connecting the preventive service with health outcomes. These linkages, together with explicit inclusion criteria, guide the literature searches for admissible evidence. Once assembled, admissible evidence is reviewed at three strata: (1) the individual study, (2) the body of evidence concerning a single linkage in the analytic framework, and (3) the body of evidence concerning the entire preventive service. For each stratum, the Task Force uses explicit criteria as general guidelines to assign one of three grades of evidence: good, fair, or poor. Good or fair quality evidence for the entire preventive service must include studies of sufficient design and quality to provide an unbroken chain of evidence-supported linkages, generalizable to the general primary care population, that connect the preventive service with health outcomes. Poor evidence contains a formidable break in the evidence chain such that the connection between the preventive service and health outcomes is uncertain. For services supported by overall good or fair evidence, the Task Force uses outcomes tables to help categorize the magnitude of benefits, harms, and net benefit from implementation of the preventive service into one of four categories: substantial, moderate, small, or zero/negative. The Task Force uses its assessment of the evidence and magnitude of net benefit to make a recommendation, coded as a letter: from A (strongly recommended) to D (recommend against). It gives an I recommendation in situations in which the evidence is insufficient to determine net benefit. The third Task Force and the EPCs will continue to examine a variety of methodologic issues and document work group progress in future communications.

Objectives The aim of the study was to generate a comprehensive bank of systematic review (SR) reporting items to inform an update of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2009 statement. Methods We searched the Enhancing the QUAlity and Transparency Of health Research Network library in May 2019 to identify all reporting guidelines for SRs that were published after 2009, regardless of the scope of the guideline. We also conducted a selective review of four guidance manuals for SRs, three tools for assessing the risk of bias in SRs, six meta-research studies evaluating the reporting quality of SRs using a tailored checklist, and five reporting guidelines for other study designs. One author screened and selected sources for inclusion, extracted reporting guidance from sources, and mapped guidance against the PRISMA 2009 checklist items. Results We included 60 sources providing guidance on reporting of SRs and meta-analyses. From these, we collated a list of 221 unique reporting items. Items were categorized into title (four items), abstract (10 items), introduction (12 items), methods (111 items), results (61 items), discussion (12 items), funding and conflicts of interest (four items), administrative information (three items), and data availability (four items). This exercise generated 175 reporting items that could be added to the guidance in the PRISMA 2009 statement. Conclusion Generation of a comprehensive item bank through review and mapping of the literature facilitates identification of missing items and those needing modification, which may not otherwise be identified by the guideline development team or from other activities commonly used to develop reporting guidelines.

Uvod: Preporučene smjernice za izvještavanje u sustavnim pregledima i metaanalizama (engl. Preferred Reporting Items for Systematic reviews and Meta-Analyses, PRISMA) prvi su puta objavljene 2009. godine kako bi autorima sustavnih pregleda omogućile transparentno izvještavanje o predmetu istraživanja, korištenim metodama i dobivenim rezultatima. Tijekom posljednjeg desetljeća postignut je značajan napredak u metodologiji i terminologiji sustavnih pregleda, što je rezultiralo potrebom za nadopunjavanjem i prilagođavanjem postojećih smjernica. Svrha rada: Predstaviti ažurirane smjernice PRISMA 2020. za izvještavanje u sustavnim pregledima. Metode: Pregledali smo 60 dokumenata sa smjernicama za izvještavanje u sustavnim pregledima s ciljem obuhvaćanja predloženih izmjena smjernica PRISMA iz 2009. godine. Tražili smo povratne informacije o predloženim izmjenama pomoću internetske ankete provedene među 110 urednika časopisa i metodologa sustavnih pregleda. O rezultatima anketa i pregleda raspravljalo se na sastanku na kojem je sudjelovao 21 član. Nakon sastanka, temeljem povratnih informacija koautora i prigodnog uzorka od 15 recenzenata sustavnih pregleda, generirali smo koncept za kontrolni popis PRISMA 2020., sažetak kontrolnog popisa, razradu i objašnjenje te dijagram toka. Rezultati: U ovom radu predstavljamo kontrolni popis za smjernice PRISMA 2020. sastavljene od 27 stavki, odnosno prošireni kontrolni popis s detaljnim preporukama za izvještavanje pojedine stavke, sažetak kontrolnog popisa PRISMA 2020. te revidirane dijagrame toka za izvorne i ažurirane preglede. Kontrolni popis uključuje nove smjernice za izvještavanje koje sadrže ažurirane metode identifikacije, odabira, procjene i sinteze istraživanja. Struktura i prikaz stavaka su izmijenjeni kako bi se olakšala njihova provedba. Smjernice PRISMA 2020. zamjenjuju smjernice iz 2009. godine. Zaključak: Svrha smjernica PRISMA 2020. je olakšati transparentnost, cjelovitost i točnost izvještavanja u sustavnim pregledima. Poboljšano izvještavanje koristiti će autorima sustavnih pregleda, autorima smjernica, kreatorima politike, zdravstvenim radnicima, pacijentima i drugim korisnicima. U svrhu postizanja navedenih ciljeva potičemo autore, urednike i recenzente da usvoje predstavljene smjernice.

The methods and results of systematic reviews should be reported in sufficient detail to allow users to assess the trustworthiness and applicability of the review findings. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was developed to facilitate transparent and complete reporting of systematic reviews and has been updated (to PRISMA 2020) to reflect recent advances in systematic review methodology and terminology. Here, we present the explanation and elaboration paper for PRISMA 2020, where we explain why reporting of each item is recommended, present bullet points that detail the reporting recommendations, and present examples from published reviews. We hope that changes to the content and structure of PRISMA 2020 will facilitate uptake of the guideline and lead to more transparent, complete, and accurate reporting of systematic reviews.

Objectives To describe the processes used to update the PRISMA 2009 statement for reporting systematic reviews, present results of a survey conducted to inform the update, summarize decisions made at the PRISMA update meeting, and describe and justify changes made to the guideline. Methods We reviewed 60 documents with reporting guidance for systematic reviews to generate suggested modifications to the PRISMA 2009 statement. We invited 220 systematic review methodologists and journal editors to complete a survey about the suggested modifications. The results of these projects were discussed at a 21-member in-person meeting. Following the meeting, we drafted the PRISMA 2020 statement and refined it based on feedback from co-authors and a convenience sample of 15 systematic reviewers. Results The review of 60 documents revealed that all topics addressed by the PRISMA 2009 statement could be modified. Of the 110 survey respondents, more than 66% recommended keeping six of the original checklist items as they were and modifying 15 of them using wording suggested by us. Attendees at the in-person meeting supported the revised wording for several items but suggested rewording for most to enhance clarity, and further refinements were made over six drafts of the guideline. Conclusions The PRISMA 2020 statement consists of updated reporting guidance for systematic reviews. We hope that providing this detailed description of the development process will enhance the acceptance and uptake of the guideline and assist those developing and updating future reporting guidelines.

In Annals' first rapid, living systematic review, Chou and colleagues examined the burden of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), SARS-CoV-1, and Middle East respiratory syndrome coronavirus on health care workers and risk factors for infection. The editorialists discuss the role of these review types and describe the features they will look for when Annals is considering rapid and living reviews for publication.

Assel and Vickers report the shortcomings of statistical code supporting research reports in high-impact medical journals. In this editorial, Annals' statistical editors argue that clearly presente...

The PRISMA statement is a reporting guideline designed to improve the completeness of reporting of systematic reviews and meta-analyses. Authors have used this guideline worldwide to prepare their reviews for publication. In the past, these reports typically compared 2 treatment alternatives. With the evolution of systematic reviews that compare multiple treatments, some of them only indirectly, authors face novel challenges for conducting and reporting their reviews. This extension of the PRISMA (Preferred Reporting Items for Systematic Reviews and Metaanalyses) statement was developed specifically to improve the reporting of systematic reviews incorporating network meta-analyses.

In meta-analyses, researchers combine data from individual studies into a summary measure to describe the benefits or harms of an intervention. This installment of the “Understanding Clinical Resea...

Heterogeneity of treatment effects (HTE) refers to the non-random variation in the magnitude or direction of a treatment effect across levels of a covariate, as measured on a selected scale, against a clinical outcome. In randomized controlled trials (RCTs), it is typically examined through subgroup analysis contrasting effects in groups of patients defined one-variable-at-a-time (e.g. males versus female; old versus young). Herein, we present guidance on an alternative approach to HTE analysis, predictive HTE analysis. The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risks with versus without the intervention, taking into account all relevant patient attributes simultaneously. The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement was developed using: a multidisciplinary technical expert panel; targeted literature reviews; simulations to characterize potential problems with predictive approaches; and a deliberative process engaging the expert panel. We distinguished two categories of predictive HTE approaches: 1) a “risk modeling” approach wherein a multivariable model predicts the risk of an outcome and is applied to disaggregate patients within RCTs to define risk-based variation in benefit; and 2) an “effect modeling” approach wherein a model is developed on RCT data by incorporating a term for treatment assignment and interactions between treatment and baseline covariates. Both approaches can be used to predict differential absolute treatment effects, the most relevant scale for clinical decision-making. We developed four sets of guidance: 1) criteria to determine when risk modeling approaches are likely to identify clinically important HTE; 2) methodological aspects of risk modeling methods; 3) considerations for translation to clinical practice; and 4) considerations and caveats in the use of effect modeling approaches. The PATH Statement, together with the PATH Statement Explanation and Elaboration document, may guide future analyses and reporting of RCTs.

In this issue, Navarese and colleagues' meta-analysis provides important preliminary information on clinical outcomes of PCSK9 inhibitors as the U.S. Food and Drug Administration considers approval...