Quality of Reporting in Preclinical Urethral Tissue Engineering Studies: A Systematic Review to Assess Adherence to the ARRIVE Guidelines

Abstract

Preclinical research within the area of urethral tissue engineering has not yet been successfully translated into an efficient therapeutic option for patients. This gap could be attributed, in part, to inadequate design and reporting of the studies employing laboratory animals. In this study, a systematic review was conducted to investigate the quality of reporting in preclinical studies utilizing tissue engineering approaches for urethral repair. The scope was on studies performed in rabbits, published between January 2014 and March 2020. Quality assessment of the data was conducted according to the Animal Research: Reporting of in Vivo Experiments (ARRIVE) guidelines by the scoring of a 38-item checklist in different categories. A total of 28 articles that fulfilled the eligibility criteria were included in the study. The range of ARRIVE score was from 0 to 100, taking into consideration having reported the item in question or not. The mean checklist score was 53%. The items that attained the highest scores included the number of animals utilized, the size of control and experimental groups, and the definition of experimental outcomes. The least frequently reported items included the data regarding the experimental procedure, housing and husbandry, determination and justification of the number of animals, and reporting of adverse events. Surprisingly, full disclosure about ethical guidelines and animal protocol approval was missing in 54% of the studies. No paper stated the sample size estimation. Overall, our study found that a large number of studies display inadequate reporting of fundamental information and that the quality of reporting improved marginally over the study period. We encourage a comprehensive implementation of the ARRIVE guidelines in animal studies exploring tissue engineering for urethral repair, not only to facilitate effective translation of preclinical research findings into clinical therapies, but also to ensure compliance with ethical principles and to minimize unnecessary animal studies.

Methodological Rigour in Preclinical Urological Studies: a 14-year systematic review to increase research quality and value

“…Temporal analysis observed that the re ection ratio of the ve factors included in ARRIVE and NIH at the same time increased over 14 years. The nding of the present study is concordant with observations made by Tariq et al [46] that claims that the quality of reporting enhanced marginally over the study period when analyzing the ARRIVE scores of the 28 articles in preclinical urethral tissue engineering from 2014 to 2020 [48]. However, in Table 4, the statistically signi cant re ection rate increased after the NIH guidelines were established, whereas it was not after the ARRIVE guidelines appeared.…”

“…The study design elements may have been performed but not reported, which could result in an underestimation of their presence. However, previous studies were also conducted by assuming that the methodological study designs applied in the experimental process would have been mentioned in the article [45,48,56,73] and underreporting of performance of methodological rigour is rare [19,51]. Therefore, it is believed that it has not had a signi cant impact on our results.…”

“…In this regard, although the researchers re ected methodological factors in the research design process by ARRIVE guidelines, the NIH guidelines were published four years later, so it may be seen that the effect was achieved. However, in addition to these factors, as pointed out in other studies, NIH may have been easy for researchers to comply with because it simply emphasizes a small number of factors [48]. From this point of view, making it easy for researchers to follow may be more important than emphasizing adherence to all factors for methodological rigor.…”

“…Therefore, more attention should be given to the methodological factors, which can enhance the effectiveness of animal studies. Unfortunately, several essential study design components are often overlooked, which leads to the irreproducibility of studies [48]. Since the decline in transparency in preclinical studies has been identi ed to be pervasive [14], preclinical research in the urological eld does not seem to be an exception.…”

Commentary - 'Invisible actors'-How poor methodology reporting compromises mouse models of oncology: A cross-sectional survey

“…Still, it's highly important to show how bad the portrait is today. The ARRIVE guidelines were first launched in 2010 [3] but they didn't stick as they should and poor reporting performance of preclinical studies has persisted in several fields [4][5][6]. Among the worst reported items is euthanasia and, as pointed out by you, only 14% of the articles fully described the procedure.…”