Search

Systematic reviews should be reported completely and accurately so that users can interpret and appraise the review findings appropriately. In this commentary, we describe key features of a major update of the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement - PRISMA 2020 - and discuss its implications for research synthesis methodologists. This article is protected by copyright. All rights reserved.

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.

Restoring perfusion to ischemic tissue is the primary goal of acute ischemic stroke care, yet only a small portion of patients receive reperfusion treatment. Since blood pressure (BP) is an important determinant of cerebral perfusion, effective BP management could facilitate reperfusion. But how BP should be managed in very early phase of ischemic stroke remains a contentious issue, due to the lack of clear evidence. Given the complex relationship between BP and cerebral blood flow (CBF)—termed cerebral autoregulation (CA)—bedside monitoring of cerebral perfusion and oxygenation could help guide BP management, thereby improve stroke patient outcome. The aim of INFOMATAS is to ‘ identify novel therapeutic targets for treatment and management in acute ischemic stroke’. In this review, we identify novel physiological parameters which could be used to guide BP management in acute stroke, and explore methodologies for monitoring them at the bedside. We outline the challenges in translating these potential prognostic markers into clinical use.

ObjectiveTo assess the methodological and reporting quality of systematic reviews (SRs) that informed recommendations in the recent American and European hypertension guidelines.Design and settingsMeta-epidemiological study. We identified SRs that were cited for class I recommendations based on Level of Evidence-A in the 2017 American College of Cardiology/American Heart Association (ACC/AHA) and the 2018 European Society of Cardiology/European Society of Hypertension (ESC/ESH) hypertension guidelines.Main outcome measuresMethodological and reporting quality of the SRs was assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR-2) checklist and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist, respectively.ResultsA total of 40 SRs was included in the analysis (28 from 2017 ACC/AHA; 22 from 2018 ESC/ESH and 10 were included in both). Based on the AMSTAR-2 assessment, only 7.5% SRs were found to be of high methodological quality, 47.5% were of moderate, each 22.5% were of low and critically low quality. Based on the PRISMA checklist assessment, a mean of 24 items (SD (2.76) were reported appropriately, and only five SRs reported all 27 items appropriately.ConclusionMethodological and reporting quality of SRs were found to vary considerably. Lack of information on the funding source of included studies, use of a protocol, integration of risk of bias assessments while interpreting findings and reporting of excluded studies were major methodological deficiencies.

Objective The objective of this study was to identify potential trial characteristics associated with reported treatment effect estimates in randomized trials of testosterone therapy in adult men. Study Design and Setting This is a meta-epidemiological study. MEDLINE was searched for meta-analyses of randomized trials of testosterone therapy in men published between 2008 and 2018. Data on trial characteristics were extracted independently by two reviewers. The impact of trial characteristics on reported treatment effects was investigated using a two-step meta-analytic approach. Results We identified 132 randomized trials, included in 19 meta-analyses, comprising data from 10,725 participants. None of the investigated design characteristics, including year of publication, sample size, trial registration status, center status, regionality, funding source, and conflict of interest were statistically significantly associated with reported treatment effects of testosterone therapy in men. Although trials rated at high risk of bias overall reported treatment effects that were 21% larger compared with trials rated at low risk of bias overall, the 95% confidence interval included the null (ratio of odds ratio: 0.79, 95% confidence interval: 0.60 to 1.03). Conclusion The present study found no clear evidence that trial characteristics are associated with treatment effects in randomized trials of testosterone therapy in men. To establish stronger evidence about the treatment effects of testosterone therapy in men, future randomized trials should not only be adequately designed but also transparently reported. Study Registration osf.io/x9g6m.

Poor reporting of medical and healthcare systematic reviews is a problem from which the sports and exercise medicine, musculoskeletal rehabilitation, and sports science fields are not immune. Transparent, accurate and comprehensive systematic review reporting helps researchers replicate methods, readers understand what was done and why, and clinicians and policy-makers implement results in practice. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement and its accompanying Explanation and Elaboration document provide general reporting examples for systematic reviews of healthcare interventions. However, implementation guidance for sport and exercise medicine, musculoskeletal rehabilitation, and sports science does not exist. The Prisma in Exercise, Rehabilitation, Sport medicine and SporTs science (PERSiST) guidance attempts to address this problem. Nineteen content experts collaborated with three methods experts to identify examples of exemplary reporting in systematic reviews in sport and exercise medicine (including physical activity), musculoskeletal rehabilitation (including physiotherapy), and sports science, for each of the PRISMA 2020 Statement items. PERSiST aims to help: (1) systematic reviewers improve the transparency and reporting of systematic reviews and (2) journal editors and peer reviewers make informed decisions about systematic review reporting quality.

ObjectivesTo investigate the extent of multiplicity of results in study reports of nutrition research, and the methods specified in systematic reviews to select results for inclusion in meta-analyses. MethodsMEDLINE and Epistemonikos were searched (January 2018 - June 2019) to identify systematic reviews with meta-analysis of the association between food/diet and health-related outcomes. A random sample of these reviews was selected, and for the first presented ( index) meta-analysis, rules used to select effect estimates to include in this meta-analysis were extracted from the reviews and their protocols. All effect estimates from the primary studies that were eligible for inclusion in the index meta-analyses were extracted. ResultsForty-two systematic reviews were included, 14 of which had a protocol. In 29% of review protocols and 69% of reviews, at least one decision rule to select effect estimates when multiple were available was specified. In 69% (204/325) of studies included in the index meta-analyses, there was at least one type of multiplicity of results. ConclusionsAuthors of systematic reviews of nutrition research should anticipate encountering multiplicity of results in the included primary studies. Specification of methods to handle multiplicity when designing reviews is therefore recommended. O_TEXTBOXWhat is new?O_ST_ABSKey FindingsC_ST_ABSO_LIAuthors of systematic reviews of nutrition research should anticipate encountering multiplicity of results in the included primary studies. C_LIO_LIDecision rules to select results for inclusion in meta-analyses of nutrition research were infrequently pre-specified. C_LI What this adds to what was known?O_LIPrevious studies have found that multiplicity of results of continuous outcomes in studies included in systematic reviews was common, and methods used to select results to include in meta-analyses were infrequently pre-specified in systematic review protocols. However, none of the studies examined meta-analyses in nutiriton research, inclusion of randomized or non-randomized studies, or where the outcome was non-continuous (e.g. binary, count or time-to-event); circumstances for which different forms of multiplicity might arise. Our study addressed this gap. C_LI What is the implication and what should change now?O_LIPre-specification of decision rules to handle multiplicity when designing reviews is recommended. In the systematic review, we recommend reporting any modifications to the specified rules, or any additions that were introduced to cover multiplicity scenarios that had not been anticipated when designing the review. C_LI C_TEXTBOX

BackgroundReporting standards, such as PRISMA aim to ensure that the methods and results of systematic reviews are described in sufficient detail to allow full transparency. Flow diagrams in evidence syntheses allow the reader to rapidly understand the core procedures used in a review and examine the attrition of irrelevant records throughout the review process. Recent research suggests that use of flow diagrams in systematic reviews is poor and of low quality and called for standardised templates to facilitate better reporting in flow diagrams. The increasing options for interactivity provided by the Internet gives us an opportunity to support easy-to-use evidence synthesis tools, and here we report on the development of tools for the production of PRISMA 2020-compliant systematic review flow diagrams.Methods and FindingsWe developed a free-to-use, Open Source R package and web-based Shiny app to allow users to design PRISMA flow diagrams for their own systematic reviews. Our tools allow users to produce standardised visualisations that transparently document the methods and results of a systematic review process in a variety of formats. In addition, we provide the opportunity to produce interactive, web-based flow diagrams (exported as HTML files), that allow readers to click on boxes of the diagram and navigate to further details on methods, results or data files. We provide an interactive example here;https://driscoll.ntu.ac.uk/prisma/.ConclusionsWe have developed a user-friendly suite of tools for producing PRISMA 2020-compliant flow diagrams for users with coding experience and, importantly, for users without prior experience in coding by making use of Shiny. These free-to-use tools will make it easier to produce clear and PRISMA 2020-compliant systematic review flow diagrams. Significantly, users can also produce interactive flow diagrams for the first time, allowing readers of their reviews to smoothly and swiftly explore and navigate to further details of the methods and results of a review. We believe these tools will increase use of PRISMA flow diagrams, improve the compliance and quality of flow diagrams, and facilitate strong science communication of the methods and results of systematic reviews by making use of interactivity. We encourage the systematic review community to make use of these tools, and provide feedback to streamline and improve their usability and efficiency.

ObjectiveTo compare results reporting and the presence of spin in COVID-19 study preprints with their finalised journal publications.DesignCross-sectional study.SettingInternational medical literature.ParticipantsPreprints and final journal publications of 67 interventional and observational studies of COVID-19 treatment or prevention from the Cochrane COVID-19 Study Register published between 1 March 2020 and 30 October 2020.Main outcome measuresStudy characteristics and discrepancies in (1) results reporting (number of outcomes, outcome descriptor, measure, metric, assessment time point, data reported, reported statistical significance of result, type of statistical analysis, subgroup analyses (if any), whether outcome was identified as primary or secondary) and (2) spin (reporting practices that distort the interpretation of results so they are viewed more favourably).ResultsOf 67 included studies, 23 (34%) had no discrepancies in results reporting between preprints and journal publications. Fifteen (22%) studies had at least one outcome that was included in the journal publication, but not the preprint; eight (12%) had at least one outcome that was reported in the preprint only. For outcomes that were reported in both preprints and journals, common discrepancies were differences in numerical values and statistical significance, additional statistical tests and subgroup analyses and longer follow-up times for outcome assessment in journal publications.At least one instance of spin occurred in both preprints and journals in 23/67 (34%) studies, the preprint only in 5 (7%), and the journal publications only in 2 (3%). Spin was removed between the preprint and journal publication in 5/67 (7%) studies; but added in 1/67 (1%) study.ConclusionsThe COVID-19 preprints and their subsequent journal publications were largely similar in reporting of study characteristics, outcomes and spin. All COVID-19 studies published as preprints and journal publications should be critically evaluated for discrepancies and spin.

Background: There are numerous guidelines developed for bone health. Yet, it is unclear whether the differences in guideline development methods explain the variability in the recommendations for vitamin D and calcium intake. The objective of this systematic review was to collate and compare recommendations for vitamin D and calcium across bone health guidelines, assess the methods used to form the recommendations, and explore which methodological factors were associated with these guideline recommendations. Methods: We searched MEDLINE, EMBASE, CINAHL, and other databases indexing guidelines to identify records in English between 2009 and 2019. Guidelines or policy statements on bone health or osteoporosis prevention for generally healthy adults aged ≥40 years were eligible for inclusion. Two reviewers independently extracted recommendations on daily vitamin D and calcium intake, supplement use, serum 25 hydroxyvitamin D [25(OH)D] level, and sunlight exposure; assessed guideline development methods against 25 recommended criteria in the World Health Organization (WHO) handbook for guideline development; and, identified types identified types of evidence underpinning the recommendations. Results: we included 47 eligible guidelines from 733 records: 74% of the guidelines provided vitamin D (200~600–4000 IU/day) and 70% provided calcium (600–1200 mg/day) recommendations, 96% and 88% recommended vitamin D and calcium supplements, respectively, and 70% recommended a specific 25(OH)D concentration. On average, each guideline met 10 (95% CI: 9–12) of the total of 25 methodological criteria for guideline development recommended by the WHO Handbook. There was uncertainty in the association between the methodological criteria and the proportion of guidelines that provided recommendations on daily vitamin D or calcium. Various types of evidence, including previous bone guidelines, nutrient reference reports, systematic reviews, observational studies, and perspectives/editorials were used to underpin the recommendations. Conclusions: There is considerable variability in vitamin D and calcium recommendations and in guideline development methods in bone health guidelines. Effort is required to strengthen the methodological rigor of guideline development and utilize the best available evidence to underpin nutrition recommendations in evidence-based guidelines on bone health.

Background: Systematic reviews underpin clinical practice and policies that guide healthcare decisions. A core component of many systematic reviews is meta-analysis, which is a statistical synthesis of results across studies. Errors in the conduct and interpretation of meta-analysis can lead to incorrect conclusions regarding the benefits and harms of interventions; and studies have shown that these errors are common. Enabling peer reviewers to better detect errors in meta-analysis through the use of a checklist provides an opportunity for these errors to be rectified before publication. To our knowledge, no such checklist exists. Objective: To develop and evaluate a checklist to detect errors in pairwise meta-analyses in systematic reviews of interventions. Methods: We will undertake a four-step process to develop the checklist. First, we will undertake a systematic review of studies that have evaluated errors in the conduct and interpretation of meta-analysis to generate a bank of items to consider for the checklist. Second, we will undertake a survey of systematic review methodologists and statisticians to seek their views on which items, of the bank of items generated in step 1, are most important to include in the checklist. Third, we will hold a virtual meeting to agree upon which items to include in the checklist. Fourth, before finalising the checklist, we will pilot with editors and peer reviewers of journals. Conclusion: The developed checklist is intended to help journal editors and peer reviewers identify errors in the application and interpretation of meta-analyses in systematic reviews. Fewer errors in the conduct and improved interpretation will lead to more accurate review findings and conclusions to inform clinical practice.

There are numerous guidelines developed for bone health. Yet it is unclear the differences in guideline development methods explain the variability in recommendations for vitamin D and calcium intakes. The objective of this systematic review was to collate and compare recommendations for vitamin D and calcium across bone health guidelines, assess methods used to form the recommendations, and explore which methodological factors were associated with these guideline recommendations. We searched MEDLINE, EMBASE, CINAHL and other databases indexing guidelines to identify records in English between 2009 and 2019. Guidelines or policy statements on bone health or osteoporosis prevention for generally healthy adults aged ≥40 years were eligible for inclusion. Two reviewers independently extracted recommendations on daily vitamin D and calcium intake, supplement use, serum 25 hydroxy vitamin D [25(OH)D] level, and sunlight exposure; assessed guideline development methods against 25 recommended criteria in the World Health Organization (WHO) Handbook for Guideline Development; and, identified types of evidence underpinning the recommendations. We included 47 eligible guidelines from 733 records: 74% of the guidelines provided vitamin D (200∼600-4000 IU/day) and 70% provided calcium (600-1200 mg/day) recommendations; 96% and 88% recommended vitamin D and calcium supplements, respectively; and 70% recommended a specific 25(OH)D concentration. The mean of meeting 25 WHO methodological criteria per guideline was 10 (95% CI: 9-12; interquartile range: 6-15). There was uncertainty in the associations between the methodological criteria and the proportion of guidelines that provided recommendations on daily vitamin D or calcium. Various types of evidence, ranging from previous bone guidelines, nutrient reference reports, systematic reviews, observational studies, to perspectives/editorials were used to underpin the recommendations. In conclusion, there is considerable variability in vitamin D and calcium recommendation and in guideline development methods in bone health guidelines. Effort is required to strengthen methodological rigor of guideline development and utilize the best available evidence to underpin public health nutrition.HighlightsThis systematic review provides evidence on the variabilities in vitamin D and calcium recommendations as well as guideline development methods in 47 bone health guidelines globally.Our findings point to continued effort to utilize the best available evidence to underpin nutrition recommendations and strengthen methodological rigor of guideline development in bone health guidelines.Registration of protocolPROSPERO: CRD42019126452

OBJECTIVE: This study aimed to analyze the reporting and conduct characteristics of systematic reviews (SRs) published in dentistry by Brazilian corresponding authors and compare reporting characteristics of Brazilian SRs with the rest of the world. METHODS: A search in PubMed was performed to identify SRs published in dentistry in 2017 assessing different aspects of oral heath irrespective of the design of included studies. From this dataset, a subgroup analysis was performed considering only SRs published by Brazilian corresponding authors. Study screening was performed by two researchers independently, while for data extraction, one of three reviewers extracted details related to reporting and conduct of SRs. The completeness of reporting of 24 characteristics, included in the PRISMA Statement of the SRs classified as treatment/therapeutic, was evaluated comparing Brazilian SR to SRs from all other countries. RESULTS: We included 117 SRs with Brazilian corresponding authors. The majority focused on dental treatments (39.3%), with oral surgery (n=19, 16.2%) as the most commonly published. Included SRs presented varying reporting/conduct characteristics. Items such as use of reporting guidelines and screening method used were well reported. However, most SRs did not assess the risk of publication bias and did not use the GRADE assessment. Four (of 24) reporting characteristics of Brazilian SRs compared to SRs from the rest of world were reported statistically significantly more frequently: mention of a SR protocol, trial registry searched, screening method reported, and assessment of risk of bias/quality of studies. CONCLUSION: Reporting and conduct characteristics of Brazilian SRs are highly variable.

Bias can arise because of the actions of primary study investigators or because of the actions of review authors, or may be unavoidable due to constraints on how research can be undertaken in practice. Where possible, assessments of risk of bias in a systematic review should be informed by evidence. This chapter summarizes some of the key evidence about bias that informs our guidance on risk-of-bias assessments in Cochrane Reviews. Many results are often available in trial reports, so review authors should think carefully about which results to assess for risk of bias. Review authors who restrict their primary analysis in this way are encouraged to perform sensitivity analyses to show how conclusions might be affected if studies at a high risk of bias were included. The chapter also addresses how source of funding and conflicts of interest of study authors may impact on study design, conduct and reporting.

Objective.To describe the experience of the first OMERACT Emerging Leaders Program (ELP).Methods.A Delphi process identified positive aspects, areas for improvement, and future directions. Core items were defined as essential if they received ≥ 70% ratings.Results.Participants valued relatable/accessible mentors (100%), including an OMERACT Executive mentor (100%), and a support network of peers (90%). Key items for future development were funding support (100%) and developing knowledge about OMERACT processes (90%) and politics (80%).Conclusion.The ELP has the potential to provide targeted training for early career researchers to develop relevant skills for future leadership roles within OMERACT.

Objectives To illustrate the use of process mining concepts, techniques, and tools to improve the systematic review process. Study Design and Setting We simulated review activities and step-specific methods in the process for systematic reviews conducted by one research team over 1 year to generate an event log of activities, with start/end dates, reviewer assignment by expertise, and person-hours worked. Process mining techniques were applied to the event log to “discover” process models, which allowed visual display, animation, or replay of the simulated review activities. Summary statistics were calculated for person-time and timelines. We also analyzed the social networks of team interactions. Results The 12 simulated reviews included an average of 3,831 titles/abstracts (range: 1,565–6,368) and 20 studies (6–42). The average review completion time was 463 days (range: 289–629) (881 person-hours [range: 243–1,752]). The average person-hours per activity were study selection 26%, data collection 24%, report preparation 23%, and meta-analysis 17%. Social network analyses showed the organizational interaction of team members, including how they worked together to complete review tasks and to hand over tasks upon completion. Conclusion Event log and process mining can be valuable tools for research teams interested in improving and modernizing the systematic review process.

Background: Funded health research is being published in journals that many regard as “predatory”, deceptive, and non-credible. We do not currently know whether funders provide guidance on how to select a journal in which to publish funded health research. Methods: We identified the largest 46 philanthropic, public, development assistance, public-private partnership, and multilateral funders of health research by expenditure, globally as well as four public funders from lower-middle income countries, from the list at https://healthresearchfunders.org. One of us identified guidance on disseminating funded research from each funders’ website (August/September 2017), then extracted information about selecting journals, which was verified by another assessor. Discrepancies were resolved by discussion. Results were summarized descriptively. This research used publicly available information; we did not seek verification with funding bodies. Results: The majority (44/50) of sampled funders indicated funding health research. 38 (of 44, 86%) had publicly available information about disseminating funded research, typically called “policies” (29, 76%). Of these 38, 36 (95%) mentioned journal publication for dissemination of which 13 (36.11%) offer variable guidance on selecting a journal, all of which relate to the funder’s open access mandate. Six funders (17%) outlined publisher requirements or features by which to select a journal. One funder linked to a document providing features of journals to look for (e.g. listed in the Directory of Open Access Journals) and to be wary of (e.g., no journal scope statement, uses direct and unsolicited marketing). Conclusions: Few funders provided guidance on how to select a journal in which to publish funded research. Funders have a duty to ensure that the research they fund is discoverable by others. This research is a benchmark for funder guidance on journal selection prior to the January 2021 implementation of Plan S (a global, funder-led initiative to ensure immediate, open access to funded, published research).

Background: 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 last decade, there have been many advances in systematic review methodology and terminology, which have necessitated an update to the guideline.Objectives: To develop the PRISMA 2020 statement for reporting systematic reviews.Methods: We reviewed 60 documents with reporting guidance for systematic reviews to generate suggested modifications to the PRISMA 2009 statement. We sought feedback on the suggested modifications through an online survey of 110 systematic review methodologists and journal editors. The results of the review and survey were discussed at a 21-member in-person meeting. Following the meeting, drafts of the PRISMA 2020 checklist, abstract checklist, explanation and elaboration and flow diagram were generated and refined iteratively based on feedback from co-authors and a convenience sample of 15 systematic reviewers.Results: In this statement paper, 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. The checklist 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. The PRISMA 2020 statement replaces the 2009 statement.Conclusions: The PRISMA 2020 statement is intended to facilitate transparent, complete and accurate reporting of systematic reviews. Improved reporting should benefit users of reviews, including guideline developers, policy makers, health care providers, patients and other stakeholders. In order to achieve this, we encourage authors, editors and peer-reviewers to adopt the guideline.

Background Investigations of transparency, reproducibility and replicability in science have been directed largely at individual studies. It is just as critical to explore these issues in syntheses of studies, such as systematic reviews, given their influence on decision-making and future research. We aim to explore various aspects relating to the transparency, reproducibility and replicability of several components of systematic reviews with meta-analysis of the effects of health, social, behavioural and educational interventions. Methods The REPRISE (REProducibility and Replicability In Syntheses of Evidence) project consists of four studies. We will evaluate the completeness of reporting and sharing of review data, analytic code and other materials in a random sample of 300 systematic reviews of interventions published in 2020 (Study 1). We will survey authors of systematic reviews to explore their views on sharing review data, analytic code and other materials and their understanding of and opinions about replication of systematic reviews (Study 2). We will then evaluate the extent of variation in results when we (a) independently reproduce meta-analyses using the same computational steps and analytic code (if available) as used in the original review (Study 3), and (b) crowdsource teams of systematic reviewers to independently replicate a subset of methods (searches for studies, selection of studies for inclusion, collection of outcome data, and synthesis of results) in a sample of the original reviews; 30 reviews will be replicated by 1 team each and 2 reviews will be replicated by 15 teams (Study 4). Discussion The REPRISE project takes a systematic approach to determine how reliable systematic reviews of interventions are. We anticipate that results of the REPRISE project will inform strategies to improve the conduct and reporting of future systematic reviews.

Background Effective drug treatments for Covid-19 are needed to decrease morbidity and mortality for the individual and to alleviate pressure on health care systems. Remdesivir showed promising results in early randomised trials but subsequently a large publicly funded trial has shown less favourable results and the evidence is interpreted differently in clinical guidelines. Systematic reviews of remdesivir have been published, but none have systematically searched for unpublished data, including regulatory documents, and assessed the risk of bias due to missing evidence. Methods We will conduct a systematic review of randomised trials comparing remdesivir to placebo or standard of care in any setting. We will include trials regardless of the severity of disease and we will include trials examining remdesivir for indications other than Covid-19 for harms analyses. We will search websites of regulatory agencies, trial registries, bibliographic databases, preprint servers and contact trial sponsors to obtain all available data, including unpublished clinical data, for all eligible trials. Our primary outcomes will be all-cause mortality and serious adverse events. Our secondary outcomes will be length of hospital stay, time to death, severe disease, and adverse events. We will assess the risk of bias using the Cochranes Risk of Bias 2 tool and the risk of bias due to missing evidence (e.g. publication bias, selective reporting bias) using the ROB-ME tool. Where appropriate we will synthesise study results by conducting random-effects meta-analysis. We will present our findings in a Summary of Findings table and rate the certainty of the evidence using the GRADE approach. Discussion By conducting a comprehensive systematic review including unpublished data (where available), we expect to be able to provide valuable information for patients and clinicians about the benefits and harms of remdesivir for the treatment of Covid-19. This will help to ensure optimal treatment for individual patients and optimal utilisation of health care resources. Systematic review registration CRD42021255915.

Resumen La declaracion PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), publicada en 2009, se diseno para ayudar a los autores de revisiones sistematicas a documentar de manera transparente el porque de la revision, que hicieron los autores y que encontraron. Durante la ultima decada, ha habido muchos avances en la metodologia y terminologia de las revisiones sistematicas, lo que ha requerido una actualizacion de esta guia. La declaracion prisma 2020 sustituye a la declaracion de 2009 e incluye una nueva guia de presentacion de las publicaciones que refleja los avances en los metodos para identificar, seleccionar, evaluar y sintetizar estudios. La estructura y la presentacion de los items ha sido modificada para facilitar su implementacion. En este articulo, presentamos la lista de verificacion PRISMA 2020 con 27 items, y una lista de verificacion ampliada que detalla las recomendaciones en la publicacion de cada item, la lista de verificacion del resumen estructurado PRISMA 2020 y el diagrama de flujo revisado para revisiones sistematicas.

[No abstract]

Background Understanding the long-term health effects of low to moderate alcohol consumption is important for establishing thresholds for minimising the lifetime risk of harm. Recent research has elucidated the dose-response relationship between alcohol and cardiovascular outcomes, showing an increased risk of harm at levels of intake previously thought to be protective. The primary objective of this review was to examine (1) whether there is a dose-response relationship between levels of alcohol consumption and long-term cognitive effects, and (2) what the effects are of different levels of consumption. Methods The review was conducted according to a pre-specified protocol. Eligible studies were those published 2007 onwards that compared cognitive function among people with different levels of alcohol consumption (measured ≥ 6 months prior to first follow-up of cognition). Major cognitive impairment was excluded. Searches were limited to MEDLINE, Embase and PsycINFO (January 2007 to April 2018). Screening, data extraction, and risk of bias assessment (ROBINS-I) were piloted by three authors, then completed by a single author and checked by a second. Analyses were undertaken to identify and characterise dose-response relationships between levels of alcohol consumption and cognition. Certainty of evidence was assessed using GRADE. Results We included 27 cohort studies (from 4786 citations). Eighteen studies examined the effects of alcohol consumption at different levels (risk of bias 16 serious, 2 critical). Ten studies provided data for dose-response analysis. The pooled dose-response relationship showed a maximum standardised mean difference (SMD) indicating slightly better cognition among women with moderate alcohol consumption compared to current non-drinkers (SMD 0.18, 95%CI 0.02 to 0.34, at 14.4 grams/day; 5 studies, very low certainty evidence), and a trivial difference for men (SMD 0.05, 95% CI 0.00 to 0.10, at 19.4 grams/day; 6 studies, very low certainty evidence). Conclusions Major limitations in the design and reporting of included studies made it impossible to discern if the effects of ‘lower’ levels of alcohol intake are due to bias. Further review of the evidence is unlikely to resolve this issue without meta-analysis of individual patient data from cohort studies that address biases in the selection of participants and classification of alcohol consumption.

Summary Background Epidemiological studies indicate that gene–environment interactions play a role in atopic dermatitis (AD). Objectives To review the evidence for gene–environment interactions in AD aetiology, focusing on filaggrin (FLG) loss‐of‐function mutations. Methods A systematic search from inception to September 2018 in Embase, MEDLINE and BIOSIS was performed. Search terms included all synonyms for AD and filaggrin/FLG; any genetic or epidemiological study design using any statistical methods were included. Quality assessment using criteria modified from guidance (ROBINS‐I and Human Genome Epidemiology Network) for nonrandomized and genetic studies was completed, including consideration of power. Heterogeneity of study design and analyses precluded the use of meta‐analysis. Results Of 1817 papers identified, 12 studies fulfilled the inclusion criteria required and performed formal interaction testing. There was some evidence for FLG–environment interactions in six of the studies (P‐value for interaction ≤ 0·05), including early‐life cat ownership, older siblings, water hardness, phthalate exposure, higher urinary phthalate metabolite levels (which all increased AD risk additional to FLG null genotype) and prolonged breastfeeding (which decreased AD risk in the context of FLG null genotype). Major limitations of published studies were the low numbers of individuals (ranging from five to 94) with AD and FLG loss‐of‐function mutations and exposure to specific environmental factors, and variation in exposure definitions. Conclusions Evidence on FLG–environment interactions in AD aetiology is limited. However, many of the studies lacked large enough sample sizes to assess these interactions fully. Further research is needed with larger sample sizes and clearly defined exposure assessment. Linked Comment: Park and Seo. Br J Dermatol 2020; 183:411., What's already known about this topic? Gene–environment interactions are considered important in the aetiology of atopic dermatitis.Loss‐of-function mutations in the gene coding filaggrin (FLG) are the most consistently reported genetic variants for atopic dermatitis.Studies have reported evidence for gene–environment interaction involving FLG and a range of different environmental exposures. What does this study add? There is some evidence for FLG–environment interactions in the aetiology of atopic dermatitis; however, the evidence is limited.Studies lack large enough sample sizes to achieve adequate power in order to assess these interactions fully. Linked Comment: Park and Seo. Br J Dermatol 2020; 183:411. Plain language summary available online

Objectives To evaluate how often reproducible research practices, which allow others to recreate the findings of studies, given the original data, are used in systematic reviews (SRs) of biomedical research. Study Design and Setting We evaluated a random sample of SRs indexed in MEDLINE during February 2014, which focused on a therapeutic intervention and reported at least one meta-analysis. Data on reproducible research practices in each SR were extracted using a 26-item form by one author, with a 20% random sample extracted in duplicate. We explored whether the use of reproducible research practices was associated with an SR being a Cochrane review, as well as with the reported use of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Results We evaluated 110 SRs of therapeutic interventions, 78 (71%) of which were non-Cochrane SRs. Across the SRs, there were 2,139 meta-analytic effects (including subgroup meta-analytic effects and sensitivity analyses), 1,551 (73%) of which were reported in sufficient detail to recreate them. Systematic reviewers reported the data needed to recreate all meta-analytic effects in 72 (65%) SRs only. This percentage was higher in Cochrane than in non-Cochrane SRs (30/32 [94%] vs. 42/78 [54%]; risk ratio 1.74, 95% confidence interval 1.39–2.18). Systematic reviewers who reported imputing, algebraically manipulating, or obtaining some data from the study author/sponsor infrequently stated which specific data were handled in this way. Only 33 (30%) SRs mentioned access to data sets and statistical code used to perform analyses. Conclusion Reproducible research practices are underused in SRs of biomedical interventions. Adoption of such practices facilitates identification of errors and allows the SR data to be reanalyzed.

Numerous studies have demonstrated low but increasing rates of data and code sharing within medical and health research disciplines. However, it remains unclear how commonly data and code are shared across all fields of medical and health research, as well as whether sharing rates are positively associated with implementation of progressive policies by publishers and funders, or growing expectations from the medical and health research community at large. Therefore this systematic review aims to synthesise the findings of medical and health science studies that have empirically investigated the prevalence of data or code sharing, or both. Objectives include the investigation of: (i) the prevalence of public sharing of research data and code alongside published articles (including preprints), (ii) the prevalence of private sharing of research data and code in response to reasonable requests, and (iii) factors associated with the sharing of either research output (e.g., the year published, the publisher’s policy on sharing, the presence of a data or code availability statement). It is hoped that the results will provide some insight into how often research data and code are shared publicly and privately, how this has changed over time, and how effective some measures such as the institution of data sharing policies and data availability statements have been in motivating researchers to share their underlying data and code.

Purpose: Sepsis after transrectal ultrasound guided prostate biopsy is an increasing problem in this era of rising antibiotic resistance. Although ertapenem prophylaxis has proved effective at our institution to reduce this, it has raised local and regional antimicrobial stewardship concerns. We investigated the possible selective effect of single dose ertapenem prophylaxis on fecal colonization with carbapenem resistant Enterobacteriaceae.Materials and Methods: Patients underwent a rectal swab prior to receiving prebiopsy ertapenem prophylaxis. A second swab was obtained at followup 4 to 6 weeks later. Swabs were screened for carbapenem resistant Enterobacteriaceae using an enhanced CDC (Centers for Disease Control) method. Prebiopsy swabs were also screened for extended spectrum β-lactamase producing and ciprofloxacin resistant Enterobacteriaceae. Patients were monitored for post-biopsy sepsis.Results: A total of 326 patients were enrolled in the study. At baseline 6.4% and 9.0% of patients had coloniza...

IntroductionComplete reporting of systematic reviews of interventions is essential to the interpretation of research findings and the reproducibility of research results. The Template for Intervention Description and Replication (TIDieR) checklist—and the version specific to systematic reviews (TIDieR-SR)—was created to provide authors and researchers an evidence-based guide for reporting trial and systematic review interventions. In this study, we apply TIDieR-SR to Cochrane systematic reviews of surgical interventions.MethodsWe searched the Cochrane Database for relevant systematic reviews. Two investigators applied inclusion/exclusion criteria to all titles/abstracts and full texts. These same investigators extracted all data in duplicate while masked to the other’s data. The primary outcome was adherence to TIDieR-SR items.ResultsTwo hundred and thirty-eight systematic reviews were included. Overall, included SRs adhered to a median of 6 (IQR 5–7) out of eight TIDieR-SR items. The item with the lowest adherence was item 7 (share intervention materials, 1/238 (0.4%).DiscussionOur results are encouraging, but the generalisability of our findings is compromised by the inclusion of only Cochrane systematic reviews. Future reporting of intervention materials is likely to improve the application of effective surgical interventions in the clinical practice.

OBJECTIVES To examine outcome reporting bias of systematic reviews registered in PROSPERO. STUDY DESIGN AND SETTING Retrospective cohort study. The primary outcomes from systematic review publications were compared with those reported in the corresponding PROSPERO records; discrepancies in the primary outcomes were assessed as upgrades, additions, omissions, or downgrades. Relative risks (RRs) and 95% confidence intervals (CI) were calculated to determine the likelihood of having a change in primary outcome when the meta-analysis result was favorable and statistically significant. RESULTS Ninety-six systematic reviews were published. A discrepancy in the primary outcome occurred in 32% of the included reviews and 39% of the reviews did not explicitly specify a primary outcome(s); 6% of the primary outcomes were omitted. There was no significant increased risk of adding/upgrading (RR, 2.14; 95% CI: 0.53, 8.63) or decreased risk of downgrading (RR, 0.76; 95% CI: 0.27, 2.17) an outcome when the meta-analysis result was favorable and statistically significant. As well, there was no significant increased risk of adding/upgrading (RR, 0.89; 95% CI: 0.31, 2.53) or decreased risk of downgrading (RR, 0.56; 95% CI: 0.29, 1.08) an outcome when the conclusion was positive. CONCLUSIONS We recommend review authors carefully consider primary outcome selection, and journals are encouraged to focus acceptance on registered systematic reviews.

Importance Reproducible research practices are essential to biomedical research because these practices promote trustworthy evidence. In systematic reviews and meta-analyses, reproducible research practices ensure that summary effects used to guide patient care are stable and trustworthy. Objective To evaluate the reproducibility in theory of meta-analyses in oncology systematic reviews cited by the 49 National Comprehensive Cancer Network (NCCN) guidelines for the treatment of cancer by site and evaluate whether Cochrane reviews or systematic reviews that report adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines use more reproducible research practices. Design, Setting, and Participants A cross-sectional investigation of all systematic reviews with at least 1 meta-analysis and at least 1 included randomized clinical trial (RCT) that are cited by NCCN guidelines for treatment of cancer by site. We scanned the reference list of all NCCN guidelines (n = 49) for potential systematic reviews and meta-analyses. All retrieved studies were screened, and data were extracted, independently and in duplicate. The analysis was carried out between May 6, 2018, and January 28, 2019. Main Outcomes and Measures The frequency of reproducible research practices, defined as (1) effect estimate and measure of precision (eg, hazard ratio with 95% confidence interval); (2) clear list of studies included for each analysis; and (3) for subgroup and sensitivity analyses, it must be clear which studies were included in each group or level. Results We identified 1124 potential systematic reviews, and 154 meta-analyses comprising 3696 meta-analytic effect size estimates were included. Only 2375 of the 3696 meta-analytic estimates (64.3%), including subgroup and sensitivity analyses, were reproducible in theory. Forest plots appear to improve the reproducibility of meta-analyses. All meta-analytic estimates were reproducible in theory in 100 systematic reviews (64.9%), and in 15 systematic reviews (9.7%), no meta-analytic estimates could potentially be reproduced. Data were said to be imputed in 29 meta-analyses, but none specified which data. Only 1 meta-analysis included a link to an online data set. Conclusions and Relevance More reproducible research practices are needed in oncology meta-analyses, as suggested by those that are cited by the NCCN. Reporting meta-analyses in forest plots and requirements for full data sharing are recommended.

Objectives To describe the experiences (including symptoms and perceived impacts on daily living) of people with a shoulder disorder. Methods Systematic review of qualitative studies. We searched for eligible qualitative studies indexed in Ovid MEDLINE, Ovid Embase, CINAHL (EBSCO), SportDiscus (EBSCO) and Ovid PsycINFO up until November 2017. Two authors independently screened studies for inclusion, appraised their methodological quality using the Critical Appraisal Skills Programme checklist, used thematic synthesis methods to generate themes describing the experiences reported by participants and assessed the confidence in the findings using the Grading of Recommendations Assessment, Development and Evaluation Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual) approach. Results The inclusion criteria were met by eight studies, which included 133 participants (49 females and 84 males) with either rotator cuff disease, adhesive capsulitis, proximal humeral fracture, shoulder instability or unspecified shoulder pain. We generated seven themes to describe what people in the included studies reported experiencing: pain; physical function/activity limitations; participation restriction; sleep disruption; cognitive dysfunction; emotional distress; and other pathophysiological manifestations (other than pain). There were interactions between the themes, with particular experiences impacting on others (e.g. pain leading to reduced activities and sleep disruption). Following grading of the evidence, we considered it likely that most of the review findings were a reasonable representation of the experiences of people with shoulder disorders. Conclusion Patients with shoulder disorders contend with considerable disruption to their life. The experiences described should be considered by researchers seeking to select the most appropriate outcomes to measure in clinical trials and other research studies in people with shoulder disorders.

Objective.To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process.Methods.At OMERACT 2018, the OMERACT Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants.Results.The qualitative review (n = 8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction, was also identified, but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71% agreement, includes 4 “mandatory” trial domains: pain, function, patient global — shoulder, and adverse events including death; and 4 “important but optional” domains: participation (recreation/work), sleep, emotional well-being, and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set.Conclusion.OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain.

[No abstract]

Summary Background The benefits and risks of testosterone treatment for women with diminished sexual wellbeing remain controversial. We did a systematic review and meta-analysis to assess potential benefits and risks of testosterone for women. Methods We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and Web of Science for blinded, randomised controlled trials of testosterone treatment of at least 12 weeks' duration completed between Jan 1, 1990, and Dec 10, 2018. We also searched drug registration applications to the European Medicine Agency and the US Food and Drug Administration to identify any unpublished data. Primary outcomes were the effects of testosterone on sexual function, cardiometabolic variables, cognitive measures, and musculoskeletal health. This study is registered with the International Prospective Register of Systematic Reviews (PROSPERO), number CRD42018104073. Findings Our search strategy retrieved 46 reports of 36 randomised controlled trials comprising 8480 participants. Our meta-analysis showed that, compared with placebo or a comparator (eg, oestrogen, with or without progestogen), testosterone significantly increased sexual function, including satisfactory sexual event frequency (mean difference 0·85, 95% CI 0·52 to 1·18), sexual desire (standardised mean difference 0·36, 95% CI 0·22 to 0·50), pleasure (mean difference 6·86, 95% CI 5·19 to 8·52), arousal (standardised mean difference 0·28, 95% CI 0·21 to 0·35), orgasm (standardised mean difference 0·25, 95% CI 0·18 to 0·32), responsiveness (standardised mean difference 0·28, 95% CI 0·21 to 0·35), and self-image (mean difference 5·64, 95% CI 4·03 to 7·26), and reduced sexual concerns (mean difference 8·99, 95% CI 6·90 to 11·08) and distress (standardised mean difference −0·27, 95% CI −0·36 to −0·17) in postmenopausal women. A significant rise in the amount of LDL-cholesterol, and reductions in the amounts of total cholesterol, HDL-cholesterol, and triglycerides, were seen with testosterone administered orally, but not when administered non-orally (eg, by transdermal patch or cream). An overall increase in weight was recorded with testosterone treatment. No effects of testosterone were reported for body composition, musculoskeletal variables, or cognitive measures, although the number of women who contributed data for these outcomes was small. Testosterone was associated with a significantly greater likelihood of reporting acne and hair growth, but no serious adverse events were recorded. Interpretation Testosterone is effective for postmenopausal women with low sexual desire causing distress, with administration via non-oral routes (eg, transdermal application) preferred because of a neutral lipid profile. The effects of testosterone on individual wellbeing and musculoskeletal and cognitive health, as well as long-term safety, warrant further investigation. Funding Australian National Health and Medical Research Council.

ObjectiveTo examine the effect of regular breakfast consumption on weight change and energy intake in people living in high income countries.DesignSystematic review and meta-analysis.Data sourcesPubMed, Ovid Medline, and CINAHL were searched for randomised controlled trials published between January 1990 and January 2018 investigating the effect of breakfast on weight or energy intake. ClinicalTrials.gov and the World Health Organization’s International Clinical Trials Registry Platform search portal were also searched in October 2018 to identify any registered yet unpublished or ongoing trials.Eligibility criteria for selecting studiesRandomised controlled trials from high income countries in adults comparing breakfast consumption with no breakfast consumption that included a measure of body weight or energy intake. Two independent reviewers extracted the data and assessed the risk of bias of included studies. Random effects meta-analyses of the effect of breakfast consumption on weight and daily energy intake were performed.ResultsOf 13 included trials, seven examined the effect of eating breakfast on weight change, and 10 examined the effect on energy intake. Meta-analysis of the results found a small difference in weight favouring participants who skipped breakfast (mean difference 0.44 kg, 95% confidence interval 0.07 to 0.82), but there was some inconsistency across trial results (I2=43%). Participants assigned to breakfast had a higher total daily energy intake than those assigned to skip breakfast (mean difference 259.79 kcal/day, 78.87 to 440.71; 1 kcal=4.18 kJ), despite substantial inconsistency across trial results (I2=80%). All of the included trials were at high or unclear risk of bias in at least one domain and had only short term follow-ups (mean period seven weeks for weight, two weeks for energy intake). As the quality of the included studies was mostly low, the findings should be interpreted with caution.ConclusionThis study suggests that the addition of breakfast might not be a good strategy for weight loss, regardless of established breakfast habit. Caution is needed when recommending breakfast for weight loss in adults, as it could have the opposite effect. Further randomised controlled trials of high quality are needed to examine the role of breakfast eating in the approach to weight management.Study registrationPROSPERO registration number CRD42017057687.

The relationship between alcohol consumption and body weight is complex and inconclusive being potentially mediated by alcohol type, habitual consumption levels and sex differences. Heavy and regular alcohol consumption has been positively correlated with increasing body weight, although it is unclear whether this is due to alcohol consumption per se or to additional energy intake from food. This review explores the effects of alcohol consumption on food energy intake in healthy adults. CINAHL Plus, EMBASE, Medline and PsycINFO were searched through February 2018 for crossover and randomised controlled trials where an alcohol dose was compared with a non-alcohol condition. Study quality was assessed using the Effective Public Health Practice Project tool. A total of twenty-two studies involving 701 participants were included from the 18 427 papers retrieved. Studies consistently demonstrated no compensation for alcoholic beverage energy intake, with dietary energy intake not decreasing due to alcoholic beverage ingestion. Meta-analyses using the random-effects model were conducted on twelve studies and demonstrated that alcoholic beverage consumption significantly increased food energy intake and total energy intake compared with a non-alcoholic comparator by weighted mean differences of 343 (95 % CI 161, 525) and 1072 (95 % CI 820, 1323) kJ, respectively. Generalisability is limited to younger adults (18–37 years), and meta-analyses for some outcomes had substantial statistical heterogeneity or evidence of small-study effects. This review suggests that adults do not compensate appropriately for alcohol energy by eating less, and a relatively modest alcohol dose may lead to an increase in food consumption.

This systematic review and meta-analysis evaluates the association of anorexia nervosa with the cancer incidence and mortality among study populations with anorexia nervosa compared with the general population or those without anorexia nervosa., Key Points Question Are people with anorexia nervosa at a higher risk of developing or dying of cancer compared with those without anorexia and the general population? Findings In this systematic review and meta-analysis of 7 cohort studies including more than 42 000 participants with anorexia nervosa, there was no association of anorexia nervosa with overall cancer incidence or mortality. Anorexia nervosa was inversely associated with breast cancer incidence but positively associated with risk of developing lung and esophageal cancer. Meaning There was no association of anorexia nervosa with risk of cancer overall and few associations of anorexia nervosa with risk of site-specific cancer., Importance Anorexia nervosa is recognized as an important cause of morbidity in young people. However, the risk of cancer in people with anorexia nervosa remains uncertain. Objective To evaluate the association of anorexia nervosa with the risk of developing or dying of cancer. Data Sources MEDLINE, Scopus, Embase, and Web of Science from database inception to January 9, 2019. Study Selection Published observational studies in humans examining the risk of cancer in people with anorexia nervosa compared with the general population or those without anorexia nervosa. Studies needed to report incidence or mortality rate ratios (RRs). Data Extraction and Synthesis Screening, data extraction, and methodological quality assessment were performed by at least 2 researchers independently. A random-effects model was used to synthesize individual studies. Heterogeneity (I2) was assessed and 95% prediction intervals (PIs) were calculated. Main Outcomes and Measures All cancer incidence and cancer mortality associated with anorexia nervosa. Secondary outcomes were site-specific cancer incidence and mortality. Results Seven cohort studies published in 10 articles (42 602 participants with anorexia nervosa) were included. Anorexia nervosa was not associated with risk of developing any cancer (4 studies in women; RR, 0.97; 95% CI, 0.89-1.06; P = .53; I2, 0%; 95% PI, 0.80-1.18; moderate confidence). Anorexia nervosa was associated with decreased breast cancer incidence (5 studies in women; RR, 0.60; 95% CI, 0.50-0.80; P

Objective This study aimed to evaluate the epidemiological and reporting characteristics of systematic reviews (SRs) in dentistry indexed within PubMed during the year 2017. Methods We searched for SRs in dentistry indexed within PubMed in 2017. Study selection was undertaken by two reviewers independently. Data related to epidemiological and reporting characteristics were extracted by one of three reviewers. A descriptive analysis of the data was performed. Characteristics of SRs were analyzed considering all SRs included and subgrouped by dental specialties. In addition, we explored if the reporting of 24 characteristics of treatment/therapeutic SRs was associated with the self-reported use of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement calculating the risk ratio (RR) with a 95% confidence interval for each characteristic. Results 495 articles fulfilled the eligibility criteria. The main specialty considered was Oral Surgery numbering 75 articles. Brazil presented the highest contribution with 117 SRs (23.6%). The reporting quality was variable. Items such as, use of the term “systematic review”, or “meta-analysis” in the title or abstract was well reported. In contrast, the study risk of bias/quality assessment method was not reported in 40.5% of SRs. In addition, only four reporting characteristics were described more often in those SR that reported using the PRISMA Statement. Conclusion A large number of SRs were published in dentistry in 2017 and the reporting and epidemiological characteristics varied among dental specialties. There is a mandatory need to improve the quality of reporting and conduct of SRs in dentistry. Clinical significance Poor reporting and conduction of SRs could generate SRs with imprecise and biased results.

Objective To determine whether physiotherapists avoid lumbar X-rays for acute non-specific low back pain and advise people to stay active. Methods We conducted a cross sectional survey of Australian physiotherapists. 880 physiotherapists were randomly sampled from Victoria (495), South Australia (158), and Western Australia (227). Physiotherapists were asked which investigations they would order and interventions they would provide for five acute low back pain (LBP) presentations described in vignettes. Four of the five vignettes represented people who would not require a plain lumbar X-ray and would benefit from advice to stay active; one described a patient with a suspected vertebral fracture and would require a plain X-ray. Participants selected from a list of response options or provided free text responses. Results Questionnaires were completed by 203 of 567 potentially eligible physiotherapists (response rate 36%). Across the four vignettes where an X-ray was not indicated, 75% (95%CI 71–78%) of physiotherapists reported they would practice concordant with the guidelines and not order an X-ray, and 62% (95%CI 57–66%) provided advice to stay active. Conclusions Most physiotherapists report intended compliance with recommendations in Australian clinical practice guidelines (CPGs) regarding avoiding the use of X-rays and providing advice to stay active for people with simple acute low back pain, given a vignette based scenario. The majority of respondents reported that they would not advise bed rest. Possible opportunities to further enhance compliance need to be developed and tested to reinforce the role of CPGs in informing physiotherapy practice.

Objectives: To explore the outcome domains and measurement instruments reported in published randomized controlled trials of physical therapy interventions for shoulder pain (rotator cuff disease, adhesive capsulitis, or nonspecific shoulder pain). Study Design and Setting: We included trials comparing physical therapy to any other intervention for shoulder pain, indexed up to March 2015 in CENTRAL, MEDLINE, EMBASE, or CINAHL Plus. Two authors independently selected trials for inclusion and extracted information on the domains and measurement instruments reported. Results: We included 171 trials. Most trials measured pain (87%), function (72%), and range of movement (67%), whereas adverse events, global assessment of treatment success, strength, and health-related quality of life were measured in 18-27% of trials, and work disability and referral for surgery were measured in less than 5% of trials. Thirty-five different measurement instruments for pain and 29 for function were noted. Measurement of function increased markedly from 1973 to 2014. In rotator cuff disease trials, there was a more frequent measurement of pain and strength and a less frequent measurement of range of movement compared with adhesive capsulitis trials. Conclusions: There was wide diversity in the domains and measurement instruments reported. Our results provide the foundation for the development of a core domain and outcome measurement set for use in future shoulder pain trials. (C) 2015 Elsevier Inc. All rights reserved.

Objectives To investigate how often systematic reviewers encounter multiple trial effect estimates that are available for inclusion in a particular meta-analysis (multiplicity of results) and the methods they use to select effect estimates. Study Design and Setting We randomly sampled Cochrane and MEDLINE-indexed non-Cochrane reviews published between January 2010 and January 2012. The first presented meta-analysis of an effect measure for a continuous outcome in each review was identified, and methods to select results to include in this meta-analysis were extracted from review protocols and reviews. All effect estimates that were available for inclusion in the meta-analyses were extracted from trial reports. Results We examined 44 reviews. Multiplicity of results was common, occurring in 49% of trial reports ( n = 210). Prespecification of decision rules to select results from multiple measurement scales and intervention/control groups (in multi-arm trials) was uncommon (19% and 14% of 21 review protocols, respectively). Overall, 70% of reviews included at least one randomized controlled trial with multiplicity of results, but this occurred less frequently in reviews with a protocol (risk difference, −25%; 95% confidence interval: −52%, 1%). Conclusion Systematic reviewers are likely to encounter multiplicity of results in the included trials. We recommend that systematic reviewers always consider predefining methods to select results to include in meta-analyses. Methods focusing on selection of measurement scales and how to deal with multi-arm trials would be most valuable.

IntroductionCurrent recommendations for vitamin D and calcium in dietary guidelines and bone health guidelines vary significantly among countries and professional organisations. It is unknown whether the methods used to develop these recommendations followed a rigourous process and how the differences in methods used may affect the recommended intakes of vitamin D and calcium. The objectives of this study are (1) collate and compare recommendations for vitamin D and calcium across guidelines, (2) appraise methodological quality of the guideline recommendations and (3) identify methodological factors that may affect the recommended intakes for vitamin D and calcium. This study will make a significant contribution to enhancing the methodological rigour in public health guidelines for vitamin D and calcium recommendations.Methods and analysesWe will conduct a systematic review to evaluate vitamin D and calcium recommendations for osteoporosis prevention in generally healthy middle-aged and older adults. Methodological assessment will be performed for each guideline against those outlined in the 2014 WHO handbook for guideline development. A systematic search strategy will be applied to locate food-based dietary guidelines and bone health guidelines indexed in various electronic databases, guideline repositories and grey literature from 1 January 2009 to 28 February 2019. Descriptive statistics will be used to summarise the data on intake recommendation and on proportion of guidelines consistent with the WHO criteria. Logistic regression, if feasible, will be used to assess the relationships between the methodological factors and the recommendation intakes.Ethics and disseminationEthics approval is not required as we will only extract published data or information from the published guidelines. Results of this review will be disseminated through conference presentations and peer-reviewed publications.PROSPERO registration numberCRD42019126452

BackgroundSeveral scales, checklists and domain-based tools for assessing risk of reporting biases exist, but it is unclear how much they vary in content and guidance. We conducted a systematic review of the content and measurement properties of such tools.MethodsWe searched for potentially relevant articles in Ovid MEDLINE, Ovid Embase, Ovid PsycINFO and Google Scholar from inception to February 2017. One author screened all titles, abstracts and full text articles, and collected data on tool characteristics.ResultsWe identified 18 tools that include an assessment of the risk of reporting bias. Tools varied in regard to the type of reporting bias assessed (eg, bias due to selective publication, bias due to selective non-reporting), and the level of assessment (eg, for the study as a whole, a particular result within a study or a particular synthesis of studies). Various criteria are used across tools to designate a synthesis as being at ‘high’ risk of bias due to selective publication (eg, evidence of funnel plot asymmetry, use of non-comprehensive searches). However, the relative weight assigned to each criterion in the overall judgement is unclear for most of these tools. Tools for assessing risk of bias due to selective non-reporting guide users to assess a study, or an outcome within a study, as ‘high’ risk of bias if no results are reported for an outcome. However, assessing the corresponding risk of bias in a synthesis that is missing the non-reported outcomes is outside the scope of most of these tools. Inter-rater agreement estimates were available for five tools.ConclusionThere are several limitations of existing tools for assessing risk of reporting biases, in terms of their scope, guidance for reaching risk of bias judgements and measurement properties. Development and evaluation of a new, comprehensive tool could help overcome present limitations.

Background The International Prospective Register of Systematic Reviews (PROSPERO) was launched in February 2011 to increase transparency of systematic reviews (SRs). There have been few investigations of the content and use of the database. We aimed to investigate the number of PROSPERO registrations from inception to 2017, and website usage in the last year. We also aimed to explore the epidemiological characteristics of and completeness of primary outcome pre-specification in a sample of PROSPERO records from 2017. Methods The PROSPERO database managers provided us with data on the annual and cumulative number of SR registrations up to October 10, 2017, and the number of visits to the PROSPERO website over the year preceding October 10, 2017. One author collected data on the focus of the SR (e.g. therapeutic, diagnostic), health area addressed, funding source and completeness of outcome pre-specification in a random sample of 150 records of SRs registered in PROSPERO between April 1, 2017 and September 30, 2017. Results As of October 10, 2017, there were 26,535 SRs registered in PROSPERO; guided by current monthly submission rates, we anticipate this figure will reach over 30,000 by the end of 2017. There has been a 10-fold increase in registrations, from 63 SRs per month in 2012 to 800 per month in 2017. In the year preceding October 10, 2017, the PROSPERO website received more than 1.75 million page views. In the random sample of 150 registered SRs, the majority were focused on a therapeutic question (78/150 [52%]), while only a few focused on a diagnostic/prognostic question (11/150 [7%]). The 150 registered SRs addressed 18 different health areas. Any information about the primary outcome other than the domain (e.g. timing, effect measures) was not pre-specified in 44/150 records (29%). Conclusions Registration of SRs in PROSPERO increased rapidly between 2011 and 2017, thus benefiting users of health evidence who want to know about ongoing SRs. Further work is needed to explore how closely published SRs adhere to the planned methods, whether greater pre-specification of outcomes prevents selective inclusion and reporting of study results, and whether registered SRs address necessary questions.

ObjectivesTo explore the outcome domains and measurement instruments reported across randomized trials of any interventions for various shoulder disorders.MethodsWe searched for shoulder trials included in Cochrane reviews published up to Issue 10, 2015, or indexed in PubMed between 2006 and 2015. Trials were eligible for inclusion if they focused on any intervention for rotator cuff disease, adhesive capsulitis, shoulder instability, glenohumeral or acromioclavicular osteoarthritis, shoulder dislocation, proximal humeral or humeral head fractures, or unspecified shoulder pain. Two authors independently selected trials for inclusion and extracted information on the domains and measurement instruments reported, with consensus discussion among all authors where required.ResultsWe included 409 trials, published between 1954 and 2015. Across the trials, we identified 319 different instruments that were classified into 32 domains. Most trials reported a measure of pain (90%), range of motion (78%), and physical function (71%). Measurement of adverse events was reported in only 31% of trials. Muscle strength was reported in 44% of trials and imaging outcomes were reported in 21% of trials. Other patient-reported outcome measures such as global assessment of treatment success, health-related quality of life, work ability, and psychological functioning, were each reported in 15% or fewer trials. Most domains were reported at a similar frequency across different shoulder disorders.ConclusionThere was wide diversity in the domains and measurement instruments reported. Our results provide the foundation for the development of a core outcome set for use in future trials across all shoulder disorders.