PRIASE 2021 guidelines for reporting animal studies in Endodontology: explanation and elaboration

Abstract

Laws and ethics require that before conducting human clinical trials, a new material, device or drug may have to undergo testing in animals in order to minimize health risks to humans, unless suitable supporting grandfather data already exist. The Preferred Reporting Items for Animal Studies in Endodontology (PRIASE) 2021 guidelines were developed exclusively for the specialty of Endodontology by integrating and adapting the ARRIVE (Animals in Research: Reporting In Vivo Experiments) guidelines and the Clinical and Laboratory Images in Publications (CLIP) principles using a validated consensus‐based methodology. Implementation of the PRIASE 2021 guidelines will reduce potential sources of bias and thus improve the quality, accuracy, reproducibility, completeness and transparency of reports describing animal studies in Endodontology. The PRIASE 2021 guidelines consist of a checklist with 11 domains and 43 individual items and a flowchart. The aim of the current document is to provide an explanation for each item in the PRIASE 2021 checklist and flowchart and is supplemented with examples from the literature in order for readers to understand their significance and to provide usage guidance. A link to the PRIASE 2021 explanation and elaboration document and PRIASE 2021 checklist and flowchart is available on the Preferred Reporting Items for study Designs in Endodontology (PRIDE) website (http://pride-endodonticguidelines.org/priase/).

The laboratory rat: age and body weight matter

“…According to guidelines for reporting animal studies, animals' body weight and age need to be reported (Hooijmans et al, 2010[ 42 ]; Osborne et al, 2018[ 76 ]; Percie du Sert et al, 2020[ 80 ]; Nagendrababu et al, 2021[ 69 ]). However, despite being available, these data frequently are not reported (Kilkenny et al, 2009[ 51 ]; Jackson et al, 2017[ 49 ]), which can cause failure to translate animal data to the human (Ioannidis, 2012[ 48 ]).…”

A priori power considerations in Endodontic Research. Do we miss the timeline?

“…2020, Nagendrababu et al . 2021b). Such initiatives have included a priori sample size calculation as a minimum requirement for ensuring reliability on the presented findings.…”

“…The findings of the present study are supportive of an overall general trend of suboptimal reporting practices in endodontic research, affecting even the most recent published reports, whilst being inbred also to the most rigorous study designs. Interestingly, only one fourth of randomized trials in Endodontics have been identified as pertaining to ‘high’ quality overall (Nagendrababu et al 2021a, b), whilst misinterpretation of research findings and distortion of results through reporting strategies have been identified both within endodontic research and also beyond (Eleftheriadi et al . 2020, Fang et al .…”

“…2020, Nagendrababu et al . 2021a, b). Apparently, the quality of the presentation of sample size reporting is of utmost significance and should be aligned to consider the specific outcome under evaluation, along with information on the effect size for which the specified power is attained.…”

Cardiac, biochemical and histopathological analysis reveals impaired heart function in hypertensive rats with apical periodontitis

“…This report was written following the Preferred Reporting Items for Animal Studies in Endodontology (PRIASE) 2021 guidelines (Nagendrababu et al, 2021a, 2021b; Figure 1).…”