A fundamental premise of scientific research is that publications should provide enough information for the study to be replicated, but as research methodologies become more complex, ensuring research rigor and reproducibility is increasingly difficult. Important details are often omitted from submitted manuscripts, and these deficiencies are sometimes not recognized during peer review. For example, a recent survey of published research using laboratory animals found that only 59% of the studies stated a hypothesis, and 4% failed to indicate the number of animals used1. Failure to adequately describe methodology has scientific, ethical, and financial implications, and this is especially true for animal research.
The CONSORT (Consolidated Standards of Reporting Trials) statement2,3 was developed to provide researchers and reviewers guidance about appropriate content in randomized clinical trials, and many journals, including JBJS, encourage authors to follow those guidelines. Building on the success of the CONSORT statement for human clinical studies, the ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines4 were developed for animal research. They aim to improve research quality, reduce bias in reporting, improve generalizability, and minimize unnecessary studies.
Specifically, the ARRIVE guidelines “consist of a checklist of 20 items describing the minimum information that all scientific publications reporting research using animals should include, such as the number and specific characteristics of animals used (including species, strain, sex, and genetic background); details of housing and husbandry; and the experimental, statistical, and analytical methods (including details of methods used to reduce bias such as randomisation and blinding). All the items in the checklist have been included to promote high-quality, comprehensive reporting to allow an accurate critical review of what was done and what was found.”4 (Fig. 1).
Joining the nearly 600 journals that have endorsed these guidelines5, JBJS is adopting the requirement that all manuscripts reporting on animal research include an annotated checklist of the ARRIVE guidelines. We recognize that some studies will be pilot or hypothesis-generation studies, but authors should report as much relevant information as possible. We also recognize that the JBJS word limit precludes including all of the details from the guidelines in the text, and therefore authors are welcome to provide additional data in an online-only appendix upon submission. We intend to make the completed ARRIVE checklist available to reviewers and editors during the review process. This change will be effective on January 1, 2020.
Anticipating the inclusion of the ARRIVE guidelines in the published results, authors may want to consider those guidelines when proposing and initiating in vivo animal research studies. To improve overall design, a companion guideline, PREPARE (Planning Research and Experimental Procedures on Animals: Recommendations for Excellence)6 is available and includes ethical and logistical topics that authors should consider when planning animal studies. In addition, as the ARRIVE guidelines are revised, we will provide the updated information to authors.
The important issue of bias against publishing negative findings has been addressed in human clinical research by mandatory prospective registration of clinical trials. The nature of preclinical animal research does not lend itself to this level of formality, but JBJS recognizes its role in encouraging the publication of both positive and negative findings. JBJS will encourage reviewers to avoid bias against negative results in well-designed studies.
Simply instituting a requirement to follow the ARRIVE guidelines will not ensure adherence by authors or reviewers. For example, a review of randomly selected papers in a journal that endorsed the guidelines found that one-half to two-thirds of publications omitted basic ethical, demographic, and baseline descriptive data7. Similarly, a survey of Swiss researchers involved in animal research found that one-half of the authors whose last publication was in a journal requiring use of the ARRIVE guidelines were unaware of the guidelines8. Successful implementation of the ARRIVE guidelines will require the input of both authors and reviewers, but we anticipate that adopting this standard will help improve the validity, reproducibility, and impact of our publications.
1. Kilkenny C, Parsons N, Kadyszewski E, Festing MF, Cuthill IC, Fry D, Hutton J, Altman DG. Survey of the quality of experimental design, statistical analysis and reporting of research using animals. PLoS One. 2009 Nov 30;4(11):e7824.
2. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.
3. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7.
4. Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. PLoS Biol. 2010 Jun 29;8(6):e1000412.
5. Cressey D. Surge in support for animal-research guidelines. Nature. 2016 Feb 1. https://www.nature.com/news/surge-in-support-for-animal-research-guidelines-1.19274
. Accessed 2019 Aug 16.
6. Smith AJ, Clutton RE, Lilley E, Hansen KEA, Brattelid T. PREPARE: guidelines for planning animal research and testing. Lab Anim. 2018 Apr;52(2):135-41. Epub 2017 Aug 3.
7. Reynolds PS. Improving reproducibility and transparency in shock: the ARRIVE guidelines need better implementation and enforcement. Shock. 2019 May 20. [Epub ahead of print].
8. Reichlin TS, Vogt L, Würbel H. The researchers’ view of scientific rigor-survey on the conduct and reporting of in vivo research. PLoS One. 2016 Dec 2;11(12):e0165999.