A systematic evaluation on reporting quality of modern studies on pulmonary heart valve implantation in large animals

Abstract

OBJECTIVES Before new heart valves can be implanted safely in humans, animal experiments have to be performed. These animal experiments have to be clearly designed, analysed and reported to assess the accuracy and importance of the findings. We aimed to provide an overview of the reporting and methodological quality of preclinical heart valve research. METHODS We conducted a systematic literature search on biological and mechanical pulmonary valve implantations in large animals. We used the Animals in Research: Reporting In Vivo Experiments (ARRIVE) guidelines to score the quality of reporting in each article. We compared the scores before and after the introduction of the ARRIVE guidelines (2010). RESULTS We screened 348 articles, of which 31 articles were included. The included articles reported a mean of 54.7% adequately scored ARRIVE items (95% confidence interval 52.2–57.3%). We did not identify a difference in reporting quality (54.7% vs 54.8%) between articles published before and after 2010. We found an unclear (lack of description) risk of selection bias, performance bias and detection bias. CONCLUSIONS The reporting quality of studies that implanted bioprosthetic or mechanical valves in the pulmonary position in the large animal model is not on the desired level. The introduction of the ARRIVE guidelines in 2010 did not improve the reporting quality in this field of research. Hereby, we want to emphasize the importance of clearly describing the methods and transparently reporting the results in animal experiments. This is of great importance for the safe translation of new heart valves to the clinic. Clinical trial registration number PROSPERO (CRD42019147895).

Agreement of farm animal behaviour and welfare studies with the ARRIVE Essential 10

“…This study found an association between the average Essential 10 score and the journal assessed. This result contrasts with the study by Uiterwijk et al (2020), who did not find a significant correlation between agreement with the item and the 5-year impact factor of the journal in which the studies were published. Our finding that AAW journal showed significantly higher compliance scores than AAB and AW must be treated cautiously because of the differences in sample sizes.…”

“…This result is in accordance with other animal research studies. For example, Uiterwijk et al (2020) reported a high percentage of articles (94%) included information concerning ethical statements in studies of pulmonary valve implantations in animals. Ting et al (2015) found 22% of articles with no statement concerning ethics approval in animal studies in the field of experimental rheumatology.…”

“…However, most importantly, none of the articles reported how the sample size was estimated. Similarly, in Uiterwijk et al (2020) sample size calculation and randomisation were poorly reported (less than 20% of the articles assessed). Sample size calculation is crucial to ensure adequate power but also reflects that the principle of reduction, developed by Russell and Burch (1959) might be under consideration.…”

Animal studies for the evaluation of in situ tissue-engineered vascular grafts — a systematic review, evidence map, and meta-analysis

“…Of all 148 studies that did not report on health/immune status of the animals, 59 studies were published before 2010, and 89 studies after 2010. A similar alarming conclusion was made in a systematic evaluation on reporting quality of the assessment of pulmonary heart valve prosthesis in large animals 62 . The authors concluded that the introduction of the ARRIVE guidelines did not improve reporting quality over the last 20 years in the field of heart valve research 62 .…”

“…A similar alarming conclusion was made in a systematic evaluation on reporting quality of the assessment of pulmonary heart valve prosthesis in large animals 62 . The authors concluded that the introduction of the ARRIVE guidelines did not improve reporting quality over the last 20 years in the field of heart valve research 62 . Of note, reporting of animal sex in the studies included in our review was much better after 2010, even though animal sex was not reported for 25% of all included animals (32% of all included studies).…”