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1.
J Clin Epidemiol ; 2021 Mar 17.
Artículo en Inglés | MEDLINE | ID: mdl-33789819

RESUMEN

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.

2.
Int J Surg ; : 105906, 2021 Mar 14.
Artículo en Inglés | MEDLINE | ID: mdl-33789826

RESUMEN

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.

4.
J Clin Epidemiol ; 2021 Mar 08.
Artículo en Inglés | MEDLINE | ID: mdl-33705957

RESUMEN

COVID-19 has disproportionately placed women in academic science on the frontlines of domestic and clinical care compared to men. As a result, women in science are publishing less and potentially acquiring less funding during COVID-19 than compared to before. This widens the pre-existing gap between men and women in prevailing, publication-based measures of productivity used to determine academic career progression. Early career women and those with intersectional identities associated with greater inequities, are facing unique challenges during this time. We argue that women will fall further behind unless academic reward systems adjust how and what they evaluate. We propose several strategies that academic institutions, funders, journals, and men in academic science can take.

8.
J Clin Epidemiol ; 134: 103-112, 2021 Feb 09.
Artículo en Inglés | MEDLINE | ID: mdl-33577987

RESUMEN

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

11.
BMC Med ; 18(1): 88, 2020 04 21.
Artículo en Inglés | MEDLINE | ID: mdl-32312313

RESUMEN

BACKGROUND: When a journal receives a duplicate publication, the ability to identify the submitted work as previously published, and reject it, is an assay to publication ethics best practices. The aim of this study was to evaluate how three different types of journals, namely open access (OA) journals, subscription-based journals, and presumed predatory journals, responded to receiving a previously published manuscript for review. METHODS: We performed a quasi-experimental study in which we submitted a previously published article to a random sample of 602 biomedical journals, roughly 200 journals from each journal type sampled: OA journals, subscription-based journals, and presumed predatory journals. Three hundred and three journals received a Word version in manuscript format, while 299 journals received the formatted publisher's PDF version of the published article. We then recorded responses to the submission received after approximately 1 month. Responses were reviewed, extracted, and coded in duplicate. Our primary outcome was the rate of rejection of the two types of submitted articles (PDF vs Word) within our three journal types. RESULTS: We received correspondence back from 308 (51.1%) journals within our study timeline (32 days); (N = 46 predatory journals, N = 127 OA journals, N = 135 subscription-based journals). Of the journals that responded, 153 received the Word version of the paper, while 155 received the PDF version. Four journals (1.3%) accepted our paper, 291 (94.5%) journals rejected the paper, and 13 (4.2%) requested a revision. A chi-square test looking at journal type, and submission type, was significant (χ2 (4) = 23.50, p < 0.001). All four responses to accept our article came from presumed predatory journals, 3 of which received the Word format and 1 that received the PDF format. Less than half of journals that rejected our submissions did so because they identified ethical issues such as plagiarism with the manuscript (133 (45.7%)). CONCLUSION: Few journals accepted our submitted paper. However, our findings suggest that all three types of journals may not have adequate safeguards in place to recognize and act on plagiarism or duplicate submissions.

12.
BMJ Evid Based Med ; 25(6): 213-219, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-32184277

RESUMEN

PURPOSE: Trustworthy reporting of quadrivalent human papillomavirus (HPV) vaccine trials is the foundation for assessing the vaccine's risks and benefits. However, several pivotal trial publications incompletely reported important methodological details and inaccurately described the formulation that the control arms received. Under the Restoring Invisible and Abandoned Trials initiative (RIAT), we aim to restore the public record regarding the content and rationale of the controls used in the trials. METHODS: We assembled a cohort (five randomised controlled trials) described as placebo-controlled using clinical study reports (CSRs) obtained from the European Medicines Agency. We extracted the content and rationale for the choice of control used in each trial across six data sources: trial publications, register records, CSR synopses, CSR main bodies, protocols and informed consent forms. RESULTS: Across data sources, the control was inconsistently reported as 'placebo'-containing aluminium adjuvant (sometimes with dose information). Amorphous aluminium hydroxyphosphate sulfate (AAHS) was not mentioned in any trial registry entry, but was mentioned in all publications and CSRs. In three of five trials, consent forms described the control as an 'inactive' substance. No rationale for the selection of the control was reported in any trial publication, register, consent form, CSR synopsis or protocol. Three trials reported the rationale for choice of control in CSRs: to preserve blinding and assess the safety of HPV virus-like particles as the 'safety profile of (AAHS) is well characterised'. CONCLUSIONS: The stated rationale of using AAHS control-to characterise the safety of the HPV virus-like particles-lacks clinical relevance. A non-placebo control may have obscured an accurate assessment of safety and the participant consent process of some trials raises ethical concerns. TRIAL REGISTRATION NUMBERS: NCT00092482, NCT00092521, NCT00092534, NCT00090220, NCT00090285.

14.
J Clin Epidemiol ; 118: 60-68, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31740319

RESUMEN

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


Asunto(s)
Guías como Asunto , Metaanálisis como Asunto , Revisiones Sistemáticas como Asunto , Lista de Verificación , Edición/normas
16.
Syst Rev ; 7(1): 32, 2018 02 20.
Artículo en Inglés | MEDLINE | ID: mdl-29463298

RESUMEN

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.


Asunto(s)
Bibliometría , Publicaciones , Revisiones Sistemáticas como Asunto , Humanos
17.
J Clin Epidemiol ; 95: 7-18, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29203419

RESUMEN

OBJECTIVES: The objective of the study was to investigate the application and interpretation of statistical analyses in a cross-section of systematic reviews (SRs) of therapeutic interventions, without restriction by journal, clinical condition, or specialty. STUDY DESIGN AND SETTING: We evaluated a random sample of SRs assembled previously, which were indexed in MEDLINE® during February 2014, focused on a treatment or prevention question, and reported at least one meta-analysis. The reported statistical methods used in each SR were extracted from articles and online appendices by one author, with a 20% random sample extracted in duplicate. RESULTS: We evaluated 110 SRs; 78/110 (71%) were non-Cochrane SRs and 55/110 (50%) investigated a pharmacological intervention. The SRs presented a median of 13 (interquartile range: 5-27) meta-analytic effects. When considering the index (primary or first reported) meta-analysis of each SR, just over half (62/110 [56%]) used the random-effects model, but few (5/62 [8%]) interpreted the meta-analytic effect correctly (as the average of the intervention effects across all studies). A statistical test for funnel plot asymmetry was reported in 17/110 (15%) SRs; however, in only 4/17 (24%) did the test include the recommended number of at least 10 studies of varying size. Subgroup analyses accompanied 42/110 (38%) index meta-analyses, but findings were not interpreted with respect to a test for interaction in 29/42 (69%) cases, and the issue of potential confounding in the subgroup analyses was not raised in any SR. CONCLUSIONS: There is scope for improvement in the application and interpretation of statistical analyses in SRs of therapeutic interventions. The involvement of statisticians on the SR team and establishment of partnerships between researchers with specialist expertise in SR methods and journal editors may help overcome these shortcomings.


Asunto(s)
Revisiones Sistemáticas como Asunto , Ensayos Clínicos como Asunto , Estudios Transversales , Interpretación Estadística de Datos , Métodos Epidemiológicos , Humanos , Metaanálisis como Asunto , Proyectos de Investigación
18.
J Clin Epidemiol ; 94: 8-18, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-29113936

RESUMEN

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.


Asunto(s)
Investigación Biomédica/métodos , Revisiones Sistemáticas como Asunto , Humanos , Reproducibilidad de los Resultados , Proyectos de Investigación
19.
J Clin Epidemiol ; 96: 133-142, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29103958

RESUMEN

OBJECTIVES: The aim of the study was to characterize methodological conduct, reporting, and quality of five knowledge synthesis (KS) approaches. STUDY DESIGN AND SETTING: Retrospective analysis of a convenience sample of five published databases of KS approaches: overview of reviews (n = 74), scoping reviews (n = 494), rapid reviews (n = 84), systematic reviews (n = 300), and network meta-analyses (NMAs; n = 456). Data in the five published databases were abstracted by two reviewers independently, any missing data for this retrospective analysis were abstracted by one experienced reviewer. Methods were appraised using the A MeaSurement Tool to Assess systematic Reviews (AMSTAR) tool. Descriptive analysis was performed. RESULTS: Reporting the use of a protocol ranged from 4% for rapid reviews to 32% for systematic reviews. The use of two reviewers for citation and full-text screening ranged from 20% for scoping reviews to 60% for NMAs. Data abstraction was performed in duplicate for 11% of rapid reviews and 54% of NMAs, and for risk of bias appraisal, this ranged from 6% for scoping reviews to 41% for NMAs. NMAs had the highest median percentage of maximum obtainable AMSTAR score (64%; Q1-Q3:45-73%), while scoping reviews had the lowest (25%; Q1-Q3:13-38%). CONCLUSION: NMAs consistently scored the highest on the AMSTAR tool likely because the purpose is to estimate treatment effects statistically. Scoping reviews scored the lowest (even after adjusting the score for not relevant items) likely because the purpose is to characterize the literature.


Asunto(s)
Proyectos de Investigación , Informe de Investigación/normas , Sesgo , Bases de Datos Bibliográficas , Humanos , Conocimiento , Metaanálisis en Red , Variaciones Dependientes del Observador , Estudios Retrospectivos , Revisiones Sistemáticas como Asunto
20.
F1000Res ; 6: 1634, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28979768

RESUMEN

Background: Scientific editors (i.e., those who make decisions on the content and policies of a journal) have a central role in the editorial process at biomedical journals. However, very little is known about the training needs of these editors or what competencies are required to perform effectively in this role. Methods: We conducted a survey of perceptions and training needs among scientific editors from major editorial organizations around the world, followed by a modified Delphi process in which we invited the same scientific editors to rate the importance of competency-related statements obtained from a previous scoping review. Results: A total of 148 participants completed the survey of perceptions and training needs. At least 80% of participants agreed on six of the 38 skill and expertise-related statements presented to them as being important or very important to their role as scientific editors. At least 80% agreed on three of the 38 statements as necessary skills they perceived themselves as possessing (well or very well).  The top five items on participants' list of top training needs were training in statistics, research methods, publication ethics, recruiting and dealing with peer reviewers, and indexing of journals. The three rounds of the Delphi were completed by 83, 83, and 73 participants, respectively, which ultimately produced a list of 23 "highly rated" competency-related statements and another 86 "included" items. Conclusion: Both the survey and the modified Delphi process will be critical for understanding knowledge and training gaps among scientific editors when designing curriculum around core competencies in the future.

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