Decreasing waste related to inadequate reporting in RCTs
Decreasing waste related to inadequate reporting in RCTs: Our research team is deeply involved in the CONSORT group to reduce waste in research due to incomplete reporting in RCTs. We evaluated the waste related to inadequate reporting of RCTs included in systematic reviews. We were leaders in proposing a conceptual shift in this field, moving from guidelines development to new approaches for improving adherence to guidelines. We demonstrated that the endorsement of the CONSORT Statement by editors was insufficient to improve adherence to guidelines. We developed and evaluated in a RCT a simple web-based tool (WebCONSORT) that allows authors to obtain a customized CONSORT checklist specific to their trial. Finally, we proposed a paradigm shift in the strategy of guidelines implementation and developed writing aid tools eliciting items and combining extensions. This development was successfully tested in a split-manuscript RCT with blinded outcome assessment. We showed that results are more completely reported when using the strict template required by the trial registry ClinicalTrials.gov as compared with peer-reviewed articles. We explored the barriers to increasing of research value with online qualitative studies. Finally, we showed that monitoring and mapping completeness of reporting over time was possible by using data routinely collected for Cochrane systematic reviews (i.e., more than 20,000 RCTs published in 3,136 journals and included in 2001 reviews). This mapping will be used to provide individual feedback to the journals and help them improve the process.
Assessing the impact of distorted reporting (spin)
We were at the forefront in developing the concept of “spin” in clinical research51. Spin is defined as specific reporting that fails to faithfully reflect the nature and range of findings and that could impact the impression the results produce in readers. We developed a classification of spin for various study designs (RCTs, observational studies, systematic reviews53) and showed that the prevalence of spin in articles was high. We also demonstrated for the first time in a RCT that spin could affect readers’ interpretation of results54. Finally, our research contradicted the belief that journalists were responsible for spin and showed that spin in the mass media was already present in published reports and press releases55. Knowing that the mass media can change public behavior, these results should have important consequences.
Addressing peer review process issues
The peer review process is a cornerstone for research dissemination and involving important cost. We showed that peer-reviewers were unable to adequately detect poor reporting or unable to delete spin in published reports and that research in this field was very poor, with only very limited research with high level of evidence being performed. We showed that too many tasks are expected from peer-reviewers, with important discrepancies between tasks clearly requested by editors and tasks considered important by reviewers. Finally, to better understand the determinants of the scientific publication and peer-review systems, we developed a comprehensive agent-based model populated by empirical data61. Using modeling, we showed that despite the huge increase in number of article submissions, the system is sustainable, although there is considerable imbalance in effort across the scientific community. This modelling also allowed for comparing different systems of peer review.