Journal Initiatives to Enhance Preclinical Research: Analyses of Stroke, Nature Medicine, Science Translational Medicine

Abstract

Background and Purpose— Preclinical research using animals often informs clinical trials. However, its value is dependent on its scientific validity and reproducibility, which are, in turn, dependent on rigorous study design and reporting. In 2011, Stroke introduced a Basic Science Checklist to enhance the reporting and methodology of its preclinical studies. Except for Nature and Science journals, few others have implemented similar initiatives. We sought to estimate the impact of these journal interventions on the quality of their published reports. Methods— All articles published in Stroke , Nature Medicine , and Science Translational Medicine over 9 to 18 years and in 2 control journals without analogous interventions over a corresponding 11.5 years were reviewed to identify reports of experiments in nonhuman mammals with proposed clinical relevance. The effect of journal interventions on the reporting and use of key study design elements was estimated via interrupted time-series analyses. Results— Of 33 009 articles screened, 4162 studies met inclusion criteria. In the 3.5 to 12 years preceding each journal’s intervention, the proportions of studies reporting and using key study design elements were stable except for blinding in Stroke and randomization in Science Translational Medicine , which were both increasing. Post-intervention, abrupt and often marked increases were seen in the reporting of randomization status (level change: +17% to +44%, P ≤0.005), blinding (level change: +20% to +40%, P ≤0.008), and sample size estimation (level change: 0% to +40%, P ≤0.002 in 2 journals). Significant but more modest improvements in the use of these study design elements were also observed. These improvements were not seen in control journals. Conclusions— Journal interventions such as Stroke ’s author submission checklist can meaningfully improve the quality of published preclinical research and should be considered to enhance study transparency and design. However, such interventions are alone insufficient to fully address widespread shortcomings in preclinical research practices.

A systematic assessment of preclinical multilaboratory studies and a comparison to single laboratory studies

“…better reporting in more recent studies), as well as accepted norms in certain fields of basic science. However, with the increasing prevalence of reporting checklists and standards in preclinical research ( Percie du Sert et al, 2020 ), future assessments will be less susceptible to this information bias ( Ramirez et al, 2020 ). We also note that our quantitative analysis included only 16 studies, and thus our results might be better regarded as a preliminary analysis that will require future confirmation when more multilaboratory studies have been conducted.…”

Modifiable Risk Factors and Residual Risk Following Coronary Revascularization

“… 48 Without a doubt, the importance of monitoring for sex-specific differences remains and cannot be understated, similar to other cardiovascular interventions. 49 Despite this, cardiovascular trials continue to report declining rates of female enrollment, 50 , 51 prompting calls for improved methodological rigor, 52 with strategies including standardized checklists 53 to improve sex-specific outcome reporting.…”

Sex‐specific in‐hospital outcomes of transcatheter aortic valve replacement with third generation transcatheter heart valves

“…This emphasizes the need for ongoing comprehensive assessment of sex-based differences in short-and long-term outcomes following TAVR considering the ever-changing patient profiles and device refinements. This is particularly important considering the noted temporal decline in the proportion of females included in cardiovascular research, 25 prompting calls to improve methodological rigor 26 via measures including standardized methodological checklists 27 and inclusion of female co-investigators. 28 Indeed, while early TAVR studies included 42-55% female participants, [29][30][31][32][33][34] the most recent lowrisk TAVR trials included only 32.5-36% females.…”