Correspondence Issue 11-12 | Nov-Dec 2013 | Vol. 121
In Support of EHP’s Proposal to Adopt the ARRIVE Guidelines
Hanna M. Vesterinen,1 Paula I. Johnson,1 Erica Koustas,2 Juleen Lam,3 Patrice Sutton,1 and Tracey J. Woodruff1
1Program on Reproductive Health and the Environment, University of California, San Francisco, Oakland, California, USA; 2Oak Ridge Institute for Science and Education, Washington, DC, USA; 3Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA, E-mail: VesterinenH@obgyn.ucsf.edu
Citation: Vesterinen HM, Johnson PI, Koustas E, Lam J, Sutton P, Woodruff TJ. 2013. In support of EHP’s proposal to adopt the ARRIVE guidelines [Letter]. Environ Health Perspect 121:A325; http://dx.doi.org/10.1289/ehp.1307775
The views expressed in this letter are those of the authors and do not reflect the views of the Oak Ridge Institute for Science and Education.
The authors declare they have no actual or potential competing financial interests.
Published: 1 December 2013
We strongly support EHP’s proposal encouraging authors who perform animal studies to adhere to the ARRIVE guidelines (http://www.nc3rs.org.uk/ARRIVE/) (Tilson and Schroeder 2013), a 20-item checklist for the reporting of key elements necessary to describe a study comprehensively and transparently (Kilkenny et al. 2010). In the clinical sphere, systematic review methods have been at the forefront of evidence-based research for the past 20 years and have demonstrated that poor reporting, particularly in domains associated with increased risk of bias, can have a significant impact on the results of a study (Juni et al. 2001). By supporting the ARRIVE guidelines, EHP recognizes the importance of reporting—and ultimately implementing—methodological approaches that can influence study quality. The ARRIVE guidelines have already been adopted by many journals, including several high-impact publications from the Nature, BioMed Central, and PLoS publishing groups. EHP will join these other prestigious journals in leading the way in recognizing the importance of reporting methodological elements in the toxicological sciences and ultimately strengthening the scientific approach.
Although we endorse the use of an approach such as the ARRIVE guidelines, the ARRIVE guidelines do not currently include all important reporting elements in a clearly defined manner. In addition, because the ARRIVE guidelines were developed in the clinical sphere, some elements that are pertinent to toxicological research are not included. We encourage EHP to simultaneously address those issues, including the following:
- Authors should adequately report sample sizes per group (Landis et al. 2012) and include explicit details of any losses to follow-up. We urge EHP to encourage authors to perform and report details of an a priori sample size calculation.
- Authors should describe any animals with “peculiarities”; this criterion is described in the “Gold Standard Publication Checklist” by Hooijmans et al. (2010) but is not necessarily covered by the “adverse events” criteria in the ARRIVE guidelines.
- Authors should report where and when the study was performed to aid in assessing whether the cohort of animals is unique from other published studies.
- Whenever possible, authors should include in the study doses that are environmentally relevant (to humans) and a measured concentration in the animal for comparison/integration with human biomarkers.
Authors should also report all of their funding sources and include a statement regarding potential conflicts of interest, including when none exist. “Conflict of interest” risk-of-bias domain has been proposed—but not yet adopted—by the Cochrane Collaboration and GRADE (Grading of Recommendations Assessment, Development and Evaluation) as an important risk of bias. This is based on empirical data from studies of the health effects of tobacco (Barnes and Bero 1997, 1998), the safety and efficacy of pharmaceuticals (Bero et al. 2007; Lexchin et al. 2003; Lundh et al. 2012), and medical procedures (Popelut et al. 2010; Shah et al. 2005) that have shown that source of funding influences the study outcome.
A criticism of the ARRIVE guidelines is that they are not topic specific. However, we believe that risk-of-bias domains used in human experimental studies that have an empirical basis—including sequence generation, allocation concealment, blinding, incomplete outcome data, and selective reporting—are directly relevant to toxicological studies. In the clinical sphere, these five criteria address nearly all issues that bear on the quality of human experimental evidence (Balshem et al. 2011). Further, these elements have been shown in the preclinical animal literature to influence study outcomes (Landis et al. 2012; Vesterinen et al. 2010). Therefore, in the absence of evidence to the contrary, the field of toxicology should proceed based on such comparability. At the same time, it would be of enormous benefit to the field of toxicology research for EHP to adopt the ARRIVE guidelines and to simultaneously encourage empirically based research to assess which criteria are most critical to the results of various types of toxicological studies that provide the evidence for decision making in environmental health.
Finally, for the EHP editors to highlight their commitment to improving the quality of the research published in EHP, they could commission or encourage research that assesses the current standard or quality of their publications and then repeat the exercise in a few years to see if the guidelines have resulted in improvements to both reporting and quality of toxicological studies [for example, see Dirnagl and Lauritzen (2011)].
Bero L, Oostvogel F, Bacchetti P, Lee K. 2007. Factors associated with findings of published trials of drug–drug comparisons: why some statins appear more efficacious than others. PLoS Med 4(6):e184; doi:10.1371/journal.pmed.0040184.
Hooijmans CR, Leenaars M, Ritskes-Hoitinga M. 2010. A gold standard publication checklist to improve the quality of animal studies, to fully integrate the Three Rs, and to make systematic reviews more feasible. Altern Lab Anim 38(2):167–182.
Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. 2010. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. Plos Biol 8(6):e1000412; doi:10.1371/journal.pbio.1000412.
Landis SC, Amara SG, Asadullah K, Austin CP, Blumenstein R, Bradley EW, et al. 2012. A call for transparent reporting to optimize the predictive value of preclinical research. Nature 490(7419):187–191.
Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. 2012. Industry sponsorship and research outcome. Cochrane Database Syst Rev 12:MR000033; doi:10.1002/14651858.MR000033.pub2.
Popelut A, Valet F, Fromentin O, Thomas A, Bouchard P. 2010. Relationship between sponsorship and failure rate of dental implants: a systematic approach. PLoS One 5(4):e10274; doi:10.1371/journal.pone.0010274.
Shah RV, Albert TJ, Bruegel-Sanchez V, Vaccaro AR, Hilibrand AS, Grauer JN. 2005. Industry support and correlation to study outcome for papers published in Spine. Spine (Phila Pa 1976) 30(9):1099–1104.
Tilson HA, Schroeder JC. 2013. Reporting of results from animal studies [Editorial]. Environ Health Perspect 121:A320–A321; doi: 10.1289/ehp.1307676.
Come visit with EHP’s Science Editor, Jane Schroeder, at the 2016 ISEE Meeting in Rome, Italy, from 1–4 September 2016. This is a great opportunity to meet a member of our team, and to learn more about the journal. A number of our Associate Editors will be in attendance as well. Jane is also co-hosting a half-day writing and publishing workshop on 4 September, following the conference.
EHP is pleased to present the abstracts from the 28th annual meeting of the International Society for Environmental Epidemiology (ISEE), held in Rome, Italy, 1–4 September 2016, and hosted by the Department of Epidemiology Lazio Regional Health Service, ASL Roma 1, and the Italian Epidemiological Association. The focus of this year’s conference is current and future challenges in exposure assessment, study design, and data analyses.
Featured Children’s Health
Birgit Claus Henn, Adrienne S. Ettinger, Marianne R. Hopkins, Rebecca Jim, Chitra Amarasiriwardena, David C. Christiani, Brent A. Coull, David C. Bellinger, and Robert O. Wright
Diane Gilbert-Diamond, Jennifer A. Emond, Emily R. Baker, Susan A. Korrick, and Margaret R. Karagas
Benjamin B. Green, Margaret R. Karagas, Tracy Punshon, Brian P. Jackson, David J. Robbins, E. Andres Houseman, and Carmen J. Marsit