Research integrity and peer review最新文献

Background: Organ donation and transplantation in China are ethically complex due to questionable informed consent and the use of prisoners as donors. Publishing works from China can be problematic. The objective of this study was to perform a 10-year follow up on Chinese journals active in donation and transplant publishing regarding the evolution of their publishing guidelines.

Methods: Eleven Chinese journals were analyzed for 7 properties: (1) ethics committee approval; (2) procedure consent; (3) publishing consent; (4) authorship criteria; (5) conflict of interest; (6) duplicate publication; and (7) data integrity. Results were compared with our 2008 study data. Additionally, open access status, impact factor, and MEDLINE-indexing were explored.

Results: Most journals heightened the ethical requirements for publishing, compared to the results of 2008. All 11 now require their published manuscripts to have data integrity. Ten of 11 require ethics committee approval and informed consent for the publication of research studies, whereas in the original study only 2 journals evidenced these requirements. Nine of 11 have criteria for authorship, require conflict of interest disclosure, and forbid duplicate publishing. None of the journals have a policy to exclude data that was obtained from unethical organ donation practices. Nine of 11 journals are MEDLINE-indexed but only 2 are open-access.

Conclusions: Most journals have improved their general ethical publishing requirements but none address unethical organ donation practices.

Background: CORE (Clarity and Openness in Reporting: E3-based) Reference (released May 2016 by the European Medical Writers Association [EMWA] and the American Medical Writers Association [AMWA]) is a complete and authoritative open-access user's guide to support the authoring of clinical study reports (CSRs) for current industry-standard-design interventional studies. CORE Reference is a content guidance resource and is not a CSR Template.TransCelerate Biopharma Inc., an alliance of biopharmaceutical companies, released a CSR Template in November 2018 and recognised CORE Reference as one of two principal sources used in its development.

Methods: The regulatory medical writing and statistical professionals who developed CORE Reference conducted a critical review of the TransCelerate CSR Template. We summarise our major findings and recommendations in this communication. We also re-examined and edited the Version 1 CORE Reference Terminology Table that we first published in 2016, and we present this as Version 2 in this communication.

Results: Our major critical review findings indicate that opportunities remain to refine the CSR Template structure and instructional text, enhance content clarity, add web links to referenced guidance documents, improve transparency to support the broad readership of CSRs, and develop supporting resources.The CORE Reference 'Terminology Table' Version 2 includes estimand as a defined term and an adaptation of the original 'worked study example' to incorporate the recently evolved concept of 'estimands'.

Conclusions: As TransCelerate's CSR Template represents an important milestone in authoring CSRs, we offer CSR authors advice and recommendations on its use, similarities, and differences with CORE Reference and advise them to consider shared interpretations between the two.

Registration: CORE Reference is registered with the EQUATOR Network. The TransCelerate CSR Template is not registered with any external organisation to the knowledge of the authors of this paper.

Background: Although a large number of clinical trials on interventions demonstrating efficacy (or lack thereof) are conducted annually, much of this evidence is not accessible to scientists and clinicians.

Objectives: We aimed to determine the publication rate of posttraumatic stress disorder (PTSD) trials that have been registered in clinical trial registries, and the factors associated with publication.

Methods: Trials, completed on January 15, 2015, were identified via the US National Institutes of Health clinical trials registry, the European Union Clinical Trials Register and the WHO International Clinical Trials Registry Platform. A systematic search for publications (published by the end of March 2018) related to each of the registered trials were then performed.

Results: Four hundred and thirty-eight of 1982 potentially eligible trials were included. Only 34% of interventional trials were registered prior to initiation, 9% were registered within 2 months of starting and 20% after trial completion. Of the 438 included trials, 72% had generated peer-reviewed publications, while an additional 7% had disseminated results in some other form (such as on the trial database), 26 months after trial completion. Randomisation of a trial was the only factor individually associated with publication, in logistic regression analysis (p < 0.001). Intervention type, university as sponsor and study registration prior to completion were factors that influenced the time to publication, using Cox regression (p < 0.001).

Conclusions: This study underscores the importance of timely and accurate publication and dissemination of trial results, in order to avoid the potential waste of resources and to ensure research integrity and patient safety. We suggest that authors and journal editors adhere to conditions set out by the International Committee of Medical Journal Editors and that more diligent data sharing is encouraged through prospective trial registration and trial reporting websites.

[This corrects the article DOI: 10.1186/s41073-016-0024-5.].

Background: The ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines are widely endorsed but compliance is limited. We sought to determine whether journal-requested completion of an ARRIVE checklist improves full compliance with the guidelines.

Methods: In a randomised controlled trial, manuscripts reporting in vivo animal research submitted to PLOS ONE (March-June 2015) were randomly allocated to either requested completion of an ARRIVE checklist or current standard practice. Authors, academic editors, and peer reviewers were blinded to group allocation. Trained reviewers performed outcome adjudication in duplicate by assessing manuscripts against an operationalised version of the ARRIVE guidelines that consists 108 items. Our primary outcome was the between-group differences in the proportion of manuscripts meeting all ARRIVE guideline checklist subitems.

Results: We randomised 1689 manuscripts (control: n = 844, intervention: n = 845), of which 1269 were sent for peer review and 762 (control: n = 340; intervention: n = 332) accepted for publication. No manuscript in either group achieved full compliance with the ARRIVE checklist. Details of animal husbandry (ARRIVE subitem 9b) was the only subitem to show improvements in reporting, with the proportion of compliant manuscripts rising from 52.1 to 74.1% (X ² = 34.0, df = 1, p = 2.1 × 10^-7) in the control and intervention groups, respectively.

Conclusions: These results suggest that altering the editorial process to include requests for a completed ARRIVE checklist is not enough to improve compliance with the ARRIVE guidelines. Other approaches, such as more stringent editorial policies or a targeted approach on key quality items, may promote improvements in reporting.

Research that has been sponsored by pharmaceutical, medical device and biotechnology companies is often presented at scientific and medical conferences. However, practices vary between organizations and it can be difficult to follow both individual conference requirements and good publication practice guidelines. Until now, no specific guidelines or recommendations have been available to describe best practice for conference presentations. This document was developed by a working group of publication professionals and uploaded to PeerJ Preprints for consultation prior to publication; an additional 67 medical societies, medical conference sites and conference companies were also asked to comment. The resulting recommendations aim to complement current good publication practice and authorship guidelines, outline the general principles of best practice for conference presentations and provide recommendations around authorship, contributorship, financial transparency, prior publication and copyright, to conference organizers, authors and industry professionals. While the authors of this document recognize that individual conference guidelines should be respected, they urge organizers to consider authorship criteria and data transparency when designing submission sites and setting parameters around word/character count and content for abstracts. It is also important to recognize that conference presentations have different limitations to full journal publications, for example, in the case of limited audiences that necessitate refocused abstracts, or where lead authors do not speak the local language, and these have been acknowledged accordingly. The authors also recognize the need for further clarity regarding copyright of previously published abstracts and have made recommendations to assist with best practice. By following Good Practice for Conference Abstracts and Presentations: GPCAP recommendations, industry professionals, authors and conference organizers will improve consistency, transparency and integrity of publications submitted to conferences worldwide.

A recent commentary argued for arbitration to resolve authorship disputes within academic research settings explaining that current mechanisms to resolve conflicts result in unclear outcomes and institutional power vested in senior investigators could compromise fairness. We argue here that arbitration is not a suitable means to resolve disputes among researchers in academia because it remains unclear who will assume the costs of arbitration, the rules of evidence do not apply to arbitration, and decisions are binding and very difficult to appeal. Instead of arbitration, we advocate for peer-based approaches involving a peer review committee and research ethics consultation to help resolve authorship disagreements. We describe the composition of an institutional peer review committee to address authorship disputes. Both of these mechanisms are found, or can be formed, within academic institutions and offer several advantages to researchers who are likely to shy away from legalistic processes and gravitate towards those handled by their peers. Peer-based approaches are cheaper than arbitration and the experts involved have knowledge about academic publishing and the culture of research in the specific field. Decisions by knowledgeable and neutral experts could reduce bias, have greater authority, and could be appealed. Not only can peer-based approaches be leveraged to resolve authorship disagreements, but they may also enhance collegiality and promote a healthy team environment.

Background: Important sex and gender differences have been found in research on diabetes complications and treatment. Reporting on whether and how sex and gender impact research findings is crucial for developing tailored diabetes care strategies. To analyze the extent to which this information is available in current diabetes research, we examined original investigations on diabetes for the integration of sex and gender in study reporting.

Methods: We examined original investigations on diabetes published between January 1 and December 31, 2015, in the top five general medicine journals and top five diabetes-specific journals (by 2015 impact factor). Data were extracted on sex and gender integration across seven article sections: title, abstract, introduction, methods, results, discussion, and limitations.

Results: We identified 155 original investigations on diabetes, including 115 randomized controlled trials (RCTs) and 40 observational studies. Sex and gender were rarely incorporated in article titles, abstracts and introductions. Most methods sections did not describe plans for sex/gender analyses; 47 (30.3%) articles described plans to control for sex/gender in the analysis and 12 (7.7%) described plans to stratify results by sex/gender. While most articles (151, 97.4%) reported the sex/gender of study participants, only 10 (6.5%) of all articles reported all study outcomes separately by sex/gender. Discussion of sex-related issues was incorporated into 21 (13.5%) original investigations; however, just 1 (0.6%) discussed gender-related issues. Comparison by journal type (general medicine vs. diabetes specific) yielded only minor differences from the overall integration results. In contrast, RCTs performed more poorly on multiple sex/gender assessment metrics compared to observational studies.

Conclusions: Sex and gender are poorly integrated in current diabetes original investigations, suggesting that substantial improvements in sex and gender data reporting are needed to inform the evidence to support sex- and gender-specific diabetes care.

Background: Reducing the number of animals used in experiments has become a priority for the governments of many countries. For these reductions to occur, animal-free alternatives must be made more available and, crucially, must be embraced by researchers.

Methods: We conducted an international online survey for academics in the field of animal science (N = 367) to explore researchers' attitudes towards the implementation of animal-free innovations. Through this survey, we address three key questions. The first question is whether scientists who use animals in their research consider governmental goals for animal-free innovations achievable and whether they would support such goals. Secondly, responders were asked to rank the importance of ten roadblocks that could hamper the implementation of animal-free innovations. Finally, responders were asked whether they would migrate (either themselves or their research) if increased animal research regulations in their country of residence restricted their research.

Results: While nearly half (40%) of the responders support governmental goals, the majority (71%) of researchers did not consider such goals achievable in their field within the near future. In terms of roadblocks for implementation of animal-free methods, ~ 80% of the responders considered 'reliability' as important, making it the most highly ranked roadblock. However, all other roadblocks were reported by most responders as somewhat important, suggesting that they must also be considered when addressing animal-free innovations. Importantly, a majority reported that they would consider migration to another country in response to a restrictive animal research policy. Thus, governments must consider the risk of researchers migrating to other institutes, states or countries, leading to a 'brain-drain' if policies are too strict or suitable animal-free alternatives are not available.

Conclusion: Our findings suggest that development and implementation of animal-free innovations are hampered by multiple factors. We outline three pillars concerning education, governmental influence and data sharing, the implementation of which may help to overcome these roadblocks to animal-free innovations.