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For example, in text, certainty might be reported explicitly in a sentence (such as Moderate-certainty evidence (downgraded for bias) indicates that) or in brackets alongside an effect estimate (such as [RR 1.17, 95% CI 0.81 to 1.68; 4 studies, 1781 participants; moderate certainty evidence]). We leave these decisions to the judgment of authors. JMT received salary from Evidence Partners Inc, creators of DistillerSR software for systematic reviews; Evidence Partners Inc was not involved in the design or outcomes of the statement and the views expressed solely represent those of the author. We estimated an overall magnitude of association from these contours, but this should be interpreted cautiously.182. For reviews of interventions, authors might clarify trade-offs between benefits and harms and how the values attached to the most important outcomes of the review might lead different people to make different decisions. If any changes were made to the inclusion or definition of the outcome domains or to the importance given to them in the review, specify the changes, along with a rationale. We assessed risk of bias in the included studies using the revised Cochrane Risk of bias tool for randomised trials (RoB 2.0) (Higgins 2016a), employing the additional guidance for cluster-randomised and cross-over trials (Eldridge 2016; Higgins 2016b). Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed. Clearly indicate if studies were ineligible because the outcomes of interest were not measured, or ineligible because the results for the outcome of interest were not reported. Characteristics of interest might include study design features, characteristics of participants, how outcomes were ascertained (such as smoking cessation self reported or biochemically validated, or specific harms systematically assessed or reported by participants as they emerged), funding source, and competing interests of study authors. Provenance and peer review: Not commissioned; externally peer reviewed. 2020. Therefore, it is critical that results are presented for all main outcomes for the main review objective(s) or question(s) regardless of the statistical significance, magnitude, or direction of effect. Any measure of cognitive function was eligible for inclusion. If the review is an update of a previous review, report results of the search and selection process for the current review and specify the number of studies included in the previous review. 45 CFR 46 Best Practices If standard phrases that incorporate the certainty of evidence were used (such as hip protectors probably reduce the risk of hip fracture slightly),130 report the intended interpretation of each phrase and the reference for the source guidance. ((electric$ or nerve$1) adj3 (stimulat$ or modulat$)).ti,ab. If synthesised results were re-expressed to a different effect measure, report the methods used to re-express results (such as meta-analysing risk ratios and computing an absolute risk reduction based on an assumed comparator risk). NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. presenting results of sensitivity analyses visually using forest plots. Together, lets create positive, long-lasting value. When study data are not amenable to meta-analysis of effect estimates, alternative statistical synthesis methods (such as calculating the median effect across studies, combining P values) or structured summaries might be used.28115 Additional guidance for reporting alternative statistical synthesis methods is available (see Synthesis Without Meta-analysis (SWiM) reporting guideline116). If a planned synthesis was not considered possible or appropriate, report this and the reason for that decision. Clinical global impression of change was assessed in Doody 2008, NCT00912288, CONCERT and CONNECTION using the CIBIC-Plus. Consider providing rationales for any notable restrictions to study eligibility. The included studies were often limited by selection bias, recall bias, small sample of marijuana-only smokers, reporting of outcomes on marijuana users and tobacco users combined, and inadequate follow-up for the development of cancerMost studies poorly assessed exposure, and some studies did not report details on exposure, preventing meta-analysis for several outcomes.198. PRISMA 2020 flow diagram template for systematic reviews (adapted from flow diagrams proposed by Boers131 and Mayo-Wilson et al.65 and Stovold et al.132). (void$ adj3 (disorder$ or dysfunct$)).ti,ab. These covariates were included a priori as potential confounders given that programmes tailored to socioeconomic position might include more intervention sessions or components or be delivered by different professionals with varying experience. Explanation: If authors performed sensitivity analyses to assess robustness of the synthesised results to decisions made during the review process (see box 5), they should provide sufficient details so that readers are able to assess the appropriateness of the analyses and could reproduce the reported results (with access to the data). If a contour-enhanced funnel plot was generated, specify the milestones of statistical significance that the plotted contour lines represent (P=0.01, 0.05, 0.1, etc).145, If a test for funnel plot asymmetry was used, report the exact P value observed for the test and potentially other relevant statistics, such as the standardised normal deviate, from which the P value is derived.106, If any sensitivity analyses seeking to explore the potential impact of missing results on the synthesis were conducted, present results of each analysis (see item #20d), compare them with results of the primary analysis, and report results with due consideration of the limitations of the statistical method.123, If studies were assessed for selective non-reporting of results by comparing outcomes and analyses pre-specified in study registers, protocols, and statistical analysis plans with results that were available in study reports, consider presenting a matrix (with rows as studies and columns as syntheses) to present the availability of study results.124. If a funnel plot was generated to evaluate small-study effects (one cause of which is reporting biases), present the plot and specify the effect estimate and measure of precision used in the plot (presented typically on the horizontal axis and vertical axis respectively106). Sensitivity analyses that removed studies with potential bias showed consistent results with the primary meta-analyses (risk ratio 1.00 for undetectable HIV-1 RNA, 1.00 for virological failure, 0.98 for severe adverse effects, and 1.02 for AIDS defining events; supplement 3E, 3F, 3H, and 3I, respectively). Growth Strategies in Busnesses and technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. In this paper, for each item, we explain why reporting of the item is recommended and present bullet points that detail the reporting recommendations. improvement in relevant variables) for each trialBecause the included resiliencetraining studies used different measurement scales to assess resilience and related constructs, we used standardised mean difference (SMD) effect sizes (Cohen's d) and their 95% confidence intervals (CIs) for continuous data in pairwise metaanalyses.179. PDF Funding: UK National Institute for Health Research ASSET and King's IoPPN Clinician Investigator Scholarship.168. D Kallmes participated in IDE trial for Benvenue Medical spinal augmentation device. However, no extra articles that fulfilled inclusion criteria were found in these searches (a flow diagram is available at https://doi.org/10.1371/journal.pone.0233220).189. Further guidance and examples about searching can be found in PRISMA-Search, an extension to the PRISMA statement for reporting literature searches in systematic reviews.41. Agency for Healthcare Research and Quality, Risk-of-bias VISualization (robvis): An R package and Shiny web app for visualizing risk-of-bias assessments, The need for individual trial results in reports of systematic reviews, Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration, Features and functioning of Data Abstraction Assistant, a software application for data abstraction during systematic reviews, Publishing protocols of systematic reviews: comparing what was done to what was planned, Selective reporting of outcomes in randomised controlled trials in systematic reviews of cystic fibrosis, Outcome reporting bias in Cochrane systematic reviews: a cross-sectional analysis, Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses, Contour-enhanced meta-analysis funnel plots help distinguish publication bias from other causes of asymmetry, GRADE guidelines: 12. Candidate search terms were identified by looking at words in the titles, abstracts and subject indexing of those records. Several approaches to selecting studies exist. Proven strategies for growth through relevance. We did separate random-effects meta-analyses for anxiety, depression, post-traumatic stress disorder (PTSD), and psychological distress outcomes. Empirical evidence suggests that peer review of search strategies is associated with improvements to search strategies, leading to retrieval of additional relevant records.43 Further guidance and examples of reporting search strategies can be found in PRISMA-Search.41. If other statistical synthesis methods were used (such as summarising effect estimates, combining P values), report the synthesised result and a measure of precision (or equivalent information, for example, the number of studies and total sample size). Again, in case of disagreement, consensus was reached on inclusion or exclusion by discussion and if necessary, the third researcher (FG) was consulted.174, For examples of systematic reviews using automation tools, crowdsourcing, or previous known assessments in the selection process, see supplementary table S1 on bmj.com, Explanation: Authors should report the methods used to collect data from reports of included studies, to enable readers to assess the potential for errors in the data presented.575859. Similarly, presenting all results is important for designing future studies. The 95% CIs (uncertainty intervals) around tau-squared and the I-squared were calculated to judge our confidence about these metrics. For example, authors might compare the current results to results of other similar systematic reviews (such as reviews that addressed the same question using different methods or that addressed slightly different questions) and explore possible reasons for discordant results. Present tables or figures indicating for each study the risk of bias in each domain/component/item assessed and overall study-level risk of bias. CRM admin. Power does not exclusively refer to the threat or use of force by one actor against another, but may also be exerted through diffuse means (such as institutions).Power may also take structural forms, as it orders actors in relation to one We then organized the studies according to which comparison intervention was used (any of the above interventions, or usual services).180. If applicable, indicate which results were not reported directly and had to be computed or estimated from other information (see item #13b). We pre-planned an adjusted model to include important study covariates related to the intensity and delivery of the intervention (number of sessions delivered (above median vs below median), whether interventions involved a trained smoking cessation specialist (yes vs no), and use of pharmacotherapy in the intervention group (yes vs no). These decisions will likely involve subjective judgments that could alter the result of a synthesis, yet the processes used and information to support the decisions are often absent from reviews. The flow diagram in figure 1 provides a template of the flow of records through the review separated by source, although other layouts may be preferable depending on the information sources consulted.65. Albatross plots were created to provide a graphical overview of the data for interventions with more than five data points for an outcome. The purpose of tabulating data varies but commonly includes the complete and transparent reporting of the results or comparing the results across study characteristics.28 Different purposes will likely lead to different table structures. Other materials might include more detailed information about the intervention delivered in the primary studies that are otherwise not available, such as a video of the specific cognitive behavioural therapy supplied by the study investigators to reviewers.73 Similarly, other material might include a list of all citations screened and any decisions about eligibility. The first aspect is risk of bias in the results of the individual studies included in a systematic review. MJP is supported by an Australian Research Council Discovery Early Career Researcher Award (DE200101618) and was previously supported by an Australian National Health and Medical Research Council (NHMRC) Early Career Fellowship (1088535) during the conduct of this research. AHRQ staff provided project oversight, reviewed the report to ensure that the analysis met methodological standards, and distributed the draft for peer review. Wikipedia He holds a spinal fusion patent license, unrelated to spinal augmentation/vertebroplasty. ISSG Search Filter Resource. If any adaptations to an existing tool to assess risk of bias in studies were made (such as omitting or modifying items), specify the adaptations. However, the checklist items are applicable to reports of systematic reviews evaluating other non-health-related interventions (for example, social or educational interventions), and many items are applicable to systematic reviews with objectives other than evaluating interventions (such as evaluating aetiology, prevalence, or prognosis). Expert Academic Essay Writers: Only the Best and Brightest Can Meet 100% of your Expectations; 3 Persuasion Methods for Justification Essays: Timely and Cheap; 11 Reasons why our Admission Essay Writing Service in the Best; 1 Promise: Highest Quality Research Paper at the Lowest Price; Response Essay Assistance: 100% Clear and Coherent For all outcomes, irrespective of whether statistical synthesis was undertaken, present for each study an effect estimate and its precision (such as standard error or 95% confidence/credible interval). Parmelli E, Liberati A, DAmico R. Reporting of outcomes in systematic reviews: comparison of protocols and published systematic reviews (abstract). If a tool was used to automatically translate search strings for one database to another,47 specify the tool used. The plot allows p-values to be interpreted in the context of the study sample size; effect contours show a standardised effect size (expressed as relative riskRR) for a given p-value and study size, providing an indication of the overall magnitude of any association. Providing a rationale for the change allows readers to assess the legitimacy of the change and whether it has potential to introduce bias in the review process.70. Provide a brief summary of the characteristics and risk of bias among studies contributing to each synthesis (meta-analysis or other). Differences from protocol: We modified the lower limit for age in our eligibility criteria from 12 years of age to 10 years of age because the age of adolescence was reduced. Justifications for assessments are available at the following (https://dx.doi.org/10.6084/m9.figshare.9159824).178, The table displays for each included study the risk-of-bias judgment for each of six domains of bias, and for the overall risk of bias in two results (selection of a product, consumption of a product); the following is an abridged version of the table presented in the review. Small p-values from negative associations appear at the left of the plot, small p-values from positive associations at the right, and studies with null results towards the middle. Explanation: Users of reviews need to know the risk of bias in the included studies to appropriately interpret the evidence. the method used to calculate the confidence interval for the summary effect (such as Wald-type confidence interval, Hartung-Knapp-Sidik-Jonkman108). Report an informative title that provides key information about the main objective or question that the review addresses (for reviews of interventions, this usually includes the population and the intervention(s) that the review addresses). Similar results were found at the additional 52week followup (MD 0.70, 95% CI 1.01 to 0.39, P<0.001). This is known as bias due to missing results and arises from reporting biases such as selective non-publication and selective non-reporting of results (see box 4).81 Direct methods for assessing the risk of bias due to missing results include comparing outcomes and analyses pre-specified in study registers, protocols, and statistical analysis plans with results that were available in study reports. whether analyses were conducted using study-level variables (where each study is included in one subgroup only), within-study contrasts (where data on subsets of participants within a study are available, allowing the study to be included in more than one subgroup), or some combination of the above.121. This is consistent with our findings that teacher training is only effective in improving early grade literacy outcomes when it is combined with teacher coaching. Thus, programs effects may be prolonged by the implementation of booster sessions conducted prior to 6 months postintervention. Indicate which studies were included in each synthesis (such as by listing each study in a forest plot or table or citing studies in the text). If the purpose is to evaluate the effects of interventions, use the Population, Intervention, Comparator, Outcome (PICO) framework or one of its variants to state the comparisons that will be made. If meta-regression was conducted, consider presenting a meta-regression scatterplot with the study effect estimates plotted against the potential effect modifier.109, Among the 4 trials that recruited critically ill patients who were and were not receiving invasive mechanical ventilation at randomization, the association between corticosteroids and lower mortality was less marked in patients receiving invasive mechanical ventilation (ratio of odds ratios (ORs), 4.34 [95% CI, 1.46-12.91]; P=0.008 based on within-trial estimates combined across trials); however, only 401 patients (120 deaths) contributed to this comparisonAll trials contributed data according to age group and sex. We thank the following contributors who provided feedback on a preliminary version of the PRISMA 2020 checklist: Jo Abbott, Fionn Bttner, Patricia Correia-Santos, Victoria Freeman, Emily A Hennessy, Rakibul Islam, Amalia (Emily) Karahalios, Kasper Krommes, Andreas Lundh, Dafne Port Nascimento, Davina Robson, Catherine Schenck-Yglesias, Mary M Scott, Sarah Tanveer and Pavel Zhelnov. There are some situations where authors might not be able to share review materials, such as when the review team are custodians rather than owners of individual participant data, or when there are legal or licensing restrictions. Explanation: The validity of a synthesis may be threatened when the available results differ systematically from the missing results. A proposed typology and guidance for systematic reviewers in the medical and health sciences. Our writers are able to handle complex assignments from their field of specialization. Advertising research is a specialized form of research that works to improve the effectiveness and efficiency of advertising. Market research is an organized effort to gather information about target markets and customers: know about them, starting with who they are. Aspirin use was associated with a 46% relative risk increase of major bleeding complications (risk ratio 1.46; 95% CI, 1.30-1.64; p <0.00001; I2 =31%; absolute risk increase 0.077%; number needed to treat to harm 1295)194. If a new risk of bias tool was developed for use in the review, describe the content of the tool and make it publicly accessible. Our primary outcome measure was the incidence of postoperative pulmonary complications, with postoperative pulmonary complications being defined as the composite of any of respiratory infection, respiratory failure, pleural effusion, atelectasis, or pneumothoraxWhere a composite postoperative pulmonary complication was not reported, we contacted corresponding authors via email to request additional information, including primary data.171, Explanation: Authors should provide a detailed description of the information sources, such as bibliographic databases, registers and reference lists that were searched or consulted, including the dates when each source was last searched, to allow readers to assess the completeness and currency of the systematic review, and facilitate updating.40 Authors should fully report the what, when, and how of the sources searched; the what and when are covered in item #6, and the how is covered in item #7. Describe sources of financial or non-financial support for the review, specifying relevant grant ID numbers for each funder. This structure is new to PRISMA 2020 and has been adopted to facilitate implementation of the guidance.2526 Authors familiar with PRISMA 2020 may opt to use the standalone statement paper23; however, for those who are new to or unfamiliar with PRISMA 2020, we encourage use of this explanation and elaboration document. The summary estimate is a weighted average of the study effect estimates, where the study weights are determined primarily by the meta-analysis model. Explanation: Discussing limitations, avoidable or unavoidable, in the review process should help readers understand the trustworthiness of the review findings. PRISMA 2020 is published as a suite of three papers: a statement paper (consisting of the 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagram23); a development paper (which outlines the steps taken to update the PRISMA 2009 statement and provides rationale for modifications to the original items24); and this paper, the updated explanation and elaboration for PRISMA 2020. For example, a standardised mean difference may have been chosen because multiple instruments or scales were used across studies to measure the same outcome domain (such as different instruments to assess depression). All of the participants left professional careers to join a full-time graduate teacher preparation program in New York City. MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE were searched via OvidSP. If any software was used to extract data from figures,64 specify the software used. memory, attention, problem-solving, language); Using multiple methods or tools to measure the same or similar outcome, for example reporting measures of global cognitive function using both the Mini-Mental State Examination and the Montreal Cognitive Assessment; At multiple time points, for example, at 1, 5, and 10years. measures of statistical heterogeneity (such as 2, I2, prediction interval). The resulting regression coefficient indicates how the outcome variable (log risk ratio (RR) for smoking cessation) changes when interventions take a socioeconomic-position-tailored versus non-socioeconomic-tailored approach. For example, for time-to-event outcomes, present a hazard ratio and its confidence interval. If any of the above materials are publicly available, report where they can be found (such as provide a link to files deposited in a public repository). Consider providing justification for the choice of effect measure. If investigations of possible causes of heterogeneity were conducted: present results regardless of the statistical significance, magnitude, or direction of effect modification. Reproduced from Hollands et al.178. Aspirin for primary prevention of cardiovascular disease: a meta-analysis with a particular focus on subgroups, WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group, Association between administration of systemic corticosteroids and mortality among critically ill patients with COVID-19: a meta-analysis, What works to improve early grade literacy in Latin America and the Caribbean? If individuals were contacted to identify studies, specify the types of individuals contacted (such as authors of studies included in the review or researchers with expertise in the area). State any thresholds or ranges used to interpret the size of effect (such as minimally important difference; ranges for no/trivial, small, moderate, and large effects) and the rationale for these thresholds. For example, groups that maintain registers of controlled trials to facilitate systematic reviews can avoid continually rescreening the same records by matching and then including/excluding those records from further consideration. ESG framework | McKinsey The regression coefficient estimates how the intervention effect in the socioeconomic-position-tailored subgroup differs from the reference group of non-socioeconomic-position-tailored interventions.185. For example, one meta-analysis might include three studies of participants aged 30 years on average, whereas another meta-analysis might include 10 studies of participants aged 60 years on average; in this case, knowing the mean age per synthesis is more meaningful than the overall mean age across all 13 studies. For instance, a risk ratio is an example of an effect measure that might be used for dichotomous outcomes.89 The chosen effect measure has implications for interpretation of the findings and might affect the meta-analysis results (such as heterogeneity90). We do not capture any email address. 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. If results were obtained from multiple sources (such as journal article, study register entry, clinical study report, correspondence with authors), report the source of the data. , P < 0.001 ) forest plots ) ).ti, ab ) (. Characteristics and risk of bias in each domain/component/item assessed and overall study-level risk of bias in each domain/component/item and... 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