Objective: To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi-stakeholder consensus. Methods: The consensus was developed via: multi-country multidisciplinary stakeholder group composition and engagement; evidence synthesis of 55 systematic reviews concerning RCT integrity; anonymised two-round modified Delphi survey with consensus threshold based on the average percentage of majority opinions; and, a final consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn). Results: There were 30 stakeholders representing 15 countries from five continents including triallists, ethicists, methodologists, statisticians, consumer representatives, industry representatives, systematic reviewers, funding body panel members, regulatory experts, authors, journal editors, peer-reviewers and advisors for resolving integrity concerns. Delphi survey response rate was 86.7% (26/30 stakeholders). There were 111 statements (73 stakeholder-provided, 46 systematic review-generated, 8 supported by both) in the initial long list, with eight additional statements provided during the consensus rounds. Through consensus the final set consolidated 81 statements (49 stakeholder-provided, 41 systematic review-generated, 9 supported by both). The entire RCT life cycle was covered by the set of statements including general aspects (n = 6), design and approval (n = 11), conduct and monitoring (n = 19), reporting of protocols and findings (n = 20), post-publication concerns (n = 12), and future research and development (n = 13). Conclusion: Implementation of this multi-stakeholder consensus statement is expected to enhance RCT integrity.
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Extant research on the role of weather in COVID-19 has produced ambiguous results and much methodological debate. Following advice emerging from this methodological debate, we take a step further in modeling effects of weather on COVID-19 spread by including interactions between weather, behavior, baseline cases, and restrictions in our model. Our model was based on secondary infection, hospitalization, restriction, weather, and mobility data per day nested with safety region in the Netherlands. Our findings show significant but inconsistent interactions. The robust effects of weather on COVID-19 spread persisted over and above these interactions, highlighting the need to account for weather with nuance and caution in public policy, communication, and forecasting
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In light of increasing calls for transparent reporting of research and prevention of detrimental research practices, we conducted a cross-sectional machine-assisted analysis of a representative sample of scientific journals' instructions to authors (ItAs) across all disciplines. We investigated addressing of 19 topics related to transparency in reporting and research integrity. Only three topics were addressed in more than one third of ItAs: conflicts of interest, plagiarism, and the type of peer review the journal employs. Health and Life Sciences journals, journals published by medium or large publishers, and journals registered in the Directory of Open Access Journals (DOAJ) were more likely to address many of the analysed topics, while Arts & Humanities journals were least likely to do so. Despite the recent calls for transparency and integrity in research, our analysis shows that most scientific journals need to update their ItAs to align them with practices which prevent detrimental research practices and ensure transparent reporting of research.
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