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Introduction Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. Methods and analysis The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare. Ethics and dissemination The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from

It is not a hyperbole to say that the foundations of academic publishing are in a state of large‐scale disruption. That this disruption remains largely under the surface is primarily because the main users of academic research — those who work at universities — rarely suffer the consequences of lack of access due to the substantial payments universities make for subscription journals (about $281 million in total in Australia in 2017).1 Outside of universities, however, gaining online access to published research legally is neither easy nor affordable. Furthermore, as we move towards an interconnected digital future, it is becoming increasingly obvious that a system whose core business model rests on controlling access is an anachronism...

This paper describes the experience of an academic institution, the Queensland University of Technology (QUT), developing training courses about research integrity practices in authorship, publication, and Journal Peer Review. The importance of providing research integrity training in these areas is now widely accepted; however, it remains an open question how best to conduct this training. For this reason, it is vital for institutions, journals, and peak bodies to share learnings. We describe how we have collaborated across our institution to develop training that supports QUT’s principles and which is in line with insights from contemporary research on best practices in learning design, universal design, and faculty involvement. We also discuss how we have refined these courses iteratively over time, and consider potential mechanisms for evaluating the effectiveness of the courses more formally.

Academic publishing is evolving and our current system of correcting research post-publication is failing, both ideologically and practically. It does not encourage researchers to engage in necessary post-publication changes in a consistent way. Worse yet, post-publication ‘updates’ can be misconstrued as punishments or admissions of misconduct. We propose a different model that publishers of research can apply to the content they publish, ensuring that any post-publication amendments are seamless, transparent and propagated to all the countless places online where descriptions of research appear. At the center of our proposal is use of the neutral term “amendment” to describe all forms of post-publication change to an article. We lay out a straightforward and consistent process that applies to each of three types of amendment that differ only in the extent to which the study is amended: minor, major, and complete. This proposed system supports the dynamic nature of the research process itself as researchers continue to refine or extend the work, and removes the emotive climate particularly associated with retractions and corrections to published work. It allows researchers to cite and share the most up-to-date and complete versions of articles with certainty, and gives decision makers access to the most up-to-date information. Crucially, however, we do not underestimate the importance of investigations of potential misconduct. This proposal allows two interrelated processes - amendment of articles and investigation of misconduct - to be uncoupled temporally, allowing a more rapid correction of the literature at a journal while institutional investigations take place, without either having to follow the others’ timeline.

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.

Background Scientific editors are responsible for deciding which articles to publish in their journals. However, we have not found documentation of their required knowledge, skills, and characteristics, or the existence of any formal core competencies for this role. Methods We describe the development of a minimum set of core competencies for scientific editors of biomedical journals. Results The 14 key core competencies are divided into three major areas, and each competency has a list of associated elements or descriptions of more specific knowledge, skills, and characteristics that contribute to its fulfillment. Conclusions We believe that these core competencies are a baseline of the knowledge, skills, and characteristics needed to perform competently the duties of a scientific editor at a biomedical journal.

Background The Internet has transformed scholarly publishing, most notably, by the introduction of open access publishing. Recently, there has been a rise of online journals characterized as ‘predatory’, which actively solicit manuscripts and charge publications fees without providing robust peer review and editorial services. We carried out a cross-sectional comparison of characteristics of potential predatory, legitimate open access, and legitimate subscription-based biomedical journals. Methods On July 10, 2014, scholarly journals from each of the following groups were identified – potential predatory journals (source: Beall’s List), presumed legitimate, fully open access journals (source: PubMed Central), and presumed legitimate subscription-based (including hybrid) journals (source: Abridged Index Medicus). MEDLINE journal inclusion criteria were used to screen and identify biomedical journals from within the potential predatory journals group. One hundred journals from each group were randomly selected. Journal characteristics (e.g., website integrity, look and feel, editors and staff, editorial/peer review process, instructions to authors, publication model, copyright and licensing, journal location, and contact) were collected by one assessor and verified by a second. Summary statistics were calculated. Results Ninety-three predatory journals, 99 open access, and 100 subscription-based journals were analyzed; exclusions were due to website unavailability. Many more predatory journals’ homepages contained spelling errors (61/93, 66%) and distorted or potentially unauthorized images (59/93, 63%) compared to open access journals (6/99, 6% and 5/99, 5%, respectively) and subscription-based journals (3/100, 3% and 1/100, 1%, respectively). Thirty-one (33%) predatory journals promoted a bogus impact metric – the Index Copernicus Value – versus three (3%) open access journals and no subscription-based journals. Nearly three quarters (n = 66, 73

Although the introduction of prospective trial registration policies has been successful in reducing waste in research, diagnostic accuracy studies are rarely registered. We describe why diagnostic accuracy studies should be registered, and where and how this can be done. Advantages of registration include the identification of unpublished studies, prevention of selective outcome reporting, prevention of unnecessary duplication of research, collaboration between researchers, and linkage of study materials...

‘Some editors are failed writers, but so are most writers.’ TS Eliot (1888–1965) Have you ever wondered what medical journal editors do? Most editors in the medical field are unpaid and the work is part of the wider culture of service provided by so many in the medical profession. Together with the editorial board and the publisher, an editor will decide the direction of the journal. For instance, decisions are made about what sort of material should be published. One of the most common tasks, however, is the daily screening of manuscripts submitted for publication, many of which are rejected without peer review owing to poor quality, redundant material or the subject of the article being beyond the scope of the journal. After deciding which peer reviewers to send an article to, the editor must make a final decision on a manuscript, which may not necessarily concur with the advice given by the reviewers. With this comes a huge amount of personal responsibility and one to the organisation the editor represents. Take the example of George Lundberg, the editor of JAMA: The Journal of the American Medical Association, who was fired from his position after 17 years with the alleged faux pas of rushing to publish an article to coincide with the Clinton impeachment hearings ‘to extract political leverage.’ Lundberg published research showing that 60% of college students surveyed in 1991 did not think that engaging in oral sex was classed as actually ‘having sex.’1 While neither the methods used in the survey nor the results were disputed, the timing of the publication at an awkward political juncture was. Extrapolating this, editors are therefore not just responsible for the content of what is published but also the impact of publications in the wider arena. Editors must also handle a great deal of correspondence, including author queries and complaints, and respond to them in a timely manner. Communication with the team, the publisher, authors and readers is a vital skill

Background - Biomedical journals are the main route for disseminating the results of health-related research. Despite this, their editors operate largely without formal training or certification. To our knowledge, no body of literature systematically identifying core competencies for scientific editors of biomedical journals exists. Therefore, we aimed to conduct a scoping review to determine what is known on the competency requirements for scientific editors of biomedical journals. Methods - We searched the MEDLINE®, Cochrane Library, Embase®, CINAHL, PsycINFO, and ERIC databases (from inception to November 2014) and conducted a grey literature search for research and non-research articles with competency-related statements (i.e. competencies, knowledge, skills, behaviors, and tasks) pertaining to the role of scientific editors of peer-reviewed health-related journals. We also conducted an environmental scan, searched the results of a previous environmental scan, and searched the websites of existing networks, major biomedical journal publishers, and organizations that offer resources for editors. Results - A total of 225 full-text publications were included, 25 of which were research articles. We extracted a total of 1,566 statements possibly related to core competencies for scientific editors of biomedical journals from these publications. We then collated overlapping or duplicate statements which produced a list of 203 unique statements. Finally, we grouped these statements into seven emergent themes: (1) dealing with authors; (2) dealing with peer reviewers; (3) journal publishing; (4) journal promotion; (5) editing; (6) ethics and integrity, and; (7) qualities and characteristics of editors. Discussion - To our knowledge, this scoping review is the first attempt to systematically identify possible competencies of editors. Limitations are that: (1) we may not have captured all aspects of a biomedical editor’s work in our searches; (2

Background - The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications. Methods - We conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision. Results - A total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n = 166; control n = 158), of which 197 were reports of randomised trials (n = 94; n = 103). Over a third (39%; n = 127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised tri

Background - Analysis of trial documentation has revealed that some industry-funded trials may be done more for marketing purposes than scientific endeavour. We aimed to define characteristics of drug trials that appear to be influenced by marketing considerations and estimate their prevalence. Methods - We examined reports of randomised controlled trials of drugs published in six general medical journals in 2011. Six investigators independently reviewed all publications, characterising them as YES/MAYBE/NO suspected marketing trials, and then met to reach consensus. Blinded researchers then extracted key trial characteristics. We used blinded cluster analysis to determine if key variables could characterise the categories of trials (YES/MAYBE/NO). Results - 41/194 (21 %) trials were categorised as YES, 14 (7 %) as MAYBE, 139 (72 %) as NO. All YES and MAYBE trials were funded by the manufacturer, compared with 37 % of NO trials (p < 0.001). A higher proportion of YES trials had authors or contributors from the manufacturer involved in study design (83 % vs. 19 %), data analysis (85 % vs.15 %) and reporting (81 % vs. 15 %) than NO trials (p < 0.001). There was no significant difference between groups in the median number of participants screened (p = 0.49), but the median number of centres recruiting participants was higher for YES compared with NO trials (171 vs. 13, p < 0.001). YES trials were not more likely to use a surrogate (42 % vs. 30 %; p = 0.38) or composite primary outcome measure (34 % vs. 19 %; p = 0.14) than NO trials. YES trials were often better reported in terms of blinding, safety outcomes and adverse events than NO trials. YES trials more frequently included speculation that might encourage clinicians to use the intervention outside of the study population compared to NO trials (59 % vs.37 %, p = 0.03). Cluster analysis based on study characteristics did not identify a clear variable structure that accurately characteris

Summary Points - As for any type of health care, decisions about interventions in the context of natural disasters, conflict, and other major healthcare emergencies must be guided by the best possible evidence. - Disaster health interventions and decision making can benefit from an evidence-based approach. - We outline how systematic reviews and methodologically sound research can build a much-needed evidence base. - We do this from the standpoint of Evidence Aid, an initiative that aims to improve access to evidence on the effects of interventions, actions, and policies before, during, and after disasters and other humanitarian emergencies, so as to improve health-related outcomes.

Free to read Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.