scholarly journals Pathology Study Design, Conduct, and Reporting to Achieve Rigor and Reproducibility in Translational Research Using Animal Models

ILAR Journal ◽  
2018 ◽  
Vol 59 (1) ◽  
pp. 4-12 ◽  
Author(s):  
Jeffrey I Everitt ◽  
Piper M Treuting ◽  
Cheryl Scudamore ◽  
Rani Sellers ◽  
Patricia V Turner ◽  
...  

AbstractIn translational research, animal models are an important tool to aid in decision-making when taking potential therapies into human clinical trials. Recently, there have been a number of papers that have suggested limited concordance of preclinical animal experiments with subsequent human clinical experience. Assessments of preclinical animal studies have led to concerns about the reproducibility of data and have highlighted the need for an emphasis on rigor and quality in the planning, conduct, analysis, and reporting of such studies. The incorporation of a wider role for the comparative pathologist using pathology best practices in the planning and conduct of animal model-based research is one way to increase the quality and reproducibility of data. The use of optimal design and planning of tissue collection, incorporation of pathology methods into written protocols, conduct of pathology procedures using accepted best practices, and the use of optimal pathology analysis and reporting methods enhance the quality of the data acquired from many types of preclinical animal models and studies. Many of these pathology practices are well established in the discipline of toxicologic pathology and have a proven and useful track record in enhancing the data from animal-based studies used in safety assessment of human therapeutics. Some of this experience can be adopted by the wider community of preclinical investigators to increase the reproducibility of animal study data.

2017 ◽  
Vol 52 (2) ◽  
pp. 135-141 ◽  
Author(s):  
Adrian J Smith ◽  
R Eddie Clutton ◽  
Elliot Lilley ◽  
Kristine E Aa Hansen ◽  
Trond Brattelid

There is widespread concern about the quality, reproducibility and translatability of studies involving research animals. Although there are a number of reporting guidelines available, there is very little overarching guidance on how to plan animal experiments, despite the fact that this is the logical place to start ensuring quality. In this paper we present the PREPARE guidelines: Planning Research and Experimental Procedures on Animals: Recommendations for Excellence. PREPARE covers the three broad areas which determine the quality of the preparation for animal studies: formulation, dialogue between scientists and the animal facility, and quality control of the various components in the study. Some topics overlap and the PREPARE checklist should be adapted to suit specific needs, for example in field research. Advice on use of the checklist is available on the Norecopa website, with links to guidelines for animal research and testing, at https://norecopa.no/PREPARE .


2011 ◽  
Vol 45 (4) ◽  
pp. 268-270 ◽  
Author(s):  
Rob B M de Vries ◽  
Carlijn R Hooijmans ◽  
Alice Tillema ◽  
Marlies Leenaars ◽  
Merel Ritskes-Hoitinga

Collecting and analysing all available literature before starting a new animal experiment is important and it is indispensable when writing systematic reviews of animal research. In practice, finding all animal studies relevant to a specific research question turns out to be anything but simple. In order to facilitate this search process, we previously developed a search filter for retrieving animal studies in the most often used biomedical database, PubMed. It is a general requirement for systematic reviews, however, that at least two databases are searched. In this report, we therefore present a similar search filter for a second important database, namely Embase. We show that our filter retrieves more animal studies than (a combination of) the options currently available in Embase. Our search filters for PubMed and Embase therefore represent valuable tools for improving the quality of (systematic) reviews and thereby of new animal experiments.


Animals ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. 1233
Author(s):  
Mario García-González ◽  
Fernando Muñoz ◽  
Antonio González-Cantalapiedra ◽  
Mónica López-Peña ◽  
Nikola Saulacic

The objective of this systematic review was to synthesize all the preclinical studies carried out in periosteal distraction osteogenesis (PDO) in order to evaluate the quality using the ARRIVE guidelines. The animal models used, and the influence of the complications, were analysed in order to establish the most appropriate models for this technique. The PRISMA statements have been followed. Bibliographic sources have been consulted manually by two reviewers. Risk of bias was evaluated using the SYRCLE tool for animal studies, and the quality of the studies with the ARRIVE 2.0 guidelines. The selection criteria established by expert researchers were applied to decide which studies should be included in the review, that resulted in twenty-four studies. Only one achieved the maximum score according to the ARRIVE 2.0 guidelines. The rabbit as an animal model has presented good results in PDO, both for calvaria and jaw. Rats have shown good results for PDO in calvaria. The minipig should not be recommended as an animal model in PDO. Despite the increase in the quality of the studies since the implementation of the ARRIVE 2.0 guidelines, it would be necessary to improve the quality of the studies to facilitate the transparency, comparison, and reproducibility of future works.


2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Wanying Xu ◽  
Dominique Pepper ◽  
Junfeng Sun ◽  
Judith Welsh ◽  
Xizhong Cui ◽  
...  

Background. Clinical studies suggest obesity paradoxically increases survival during bacterial infection and sepsis but decreases it with influenza, but these studies are observational. By contrast, animal studies of obesity in infection can prospectively compare obese versus nonobese controls. We performed a systematic review and meta-analysis of animal investigations to further examine obesity’s survival effect in infection and sepsis. Methods. Databases were searched for studies comparing survival in obese versus nonobese animals following bacteria, lipopolysaccharide, or influenza virus challenges. Results. Twenty-one studies (761 obese and 603 control animals) met the inclusion criteria. Obesity reduced survival in 19 studies (11 significantly) and the odds ratio (95% CI) of survival (0.21(0.13, 0.35); I2 = 64%, p<0.01p < 0.01) but with high heterogeneity. Obesity reduced survival (1) consistently in both single-strain bacteria- and lipopolysaccharide-challenged studies (n = 6 studies, 0.21(0.13, 0.34); I2 = 31%, p=0.20 and n = 5, 0.22(0.13, 0.36); I2 = 0%, p=0.59, respectively), (2) not significantly with cecal ligation and puncture (n = 4, 0.72(0.08, 6.23); I2 = 75%, p<0.01), and (3) significantly with influenza but with high heterogeneity (n = 6, 0.12(0.04, 0.34); I2 = 73%, p<0.01). Obesity’s survival effects did not differ significantly comparing the four challenge types (p=0.49). Animal models did not include antimicrobials or glycemic control and study quality was low. Conclusions. Preclinical and clinical studies together emphasize the need for prospective studies in patients accurately assessing obesity’s impact on survival during severe infection.


2020 ◽  
Vol 48 (2) ◽  
pp. 85-91
Author(s):  
Vijay Pal Singh ◽  
Ayushi Jain ◽  
Shubhra Gupta ◽  
Manudharshy Vijayakumar ◽  
Kunal Pratap ◽  
...  

The quality of animal experiments in terms of appropriate reporting is a concern, particularly with regard to their validity and the recording of the measures taken to reduce various types of bias. A systematic survey of 1371 and 236 publications from India and Sri Lanka, respectively, which were published between 1905 and 2017 and indexed in NCBI-PubMed, Cinhal, MEDLINE and Scopus, was carried out. The level of detail in the descriptions of animals used and the measures taken to reduce bias were analysed in each article. Selected parameters from the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines, such as age, weight, sex, sample size calculation, blinding and randomisation were considered. The findings revealed poor reporting standards in animal experiments carried out in India and Sri Lanka, confirming the limited impact of the ARRIVE guidelines. These findings emphasise the urgent need for improvements in the peer review process, both prior to a study being set up and in the post-study reporting phase, and for more stringent adherence to the ARRIVE guidelines in the reporting of animal experiments.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Chema Strik ◽  
Kimberley E. Wever ◽  
Martijn W. J. Stommel ◽  
Harry van Goor ◽  
Richard P. G. ten Broek

AbstractToday, 40–66% of elective procedures in general surgery are reoperations. During reoperations, the need for adhesiolysis results in increased operative time and a more complicated convalescence. In pre-clinical evaluation, adhesion barriers are tested for their efficacy in preventing ‘de novo’ adhesion formation, However, it is unknown to which extent barriers are tested for prevention of adhesion reformation. The aim of this systematic review and meta-analysis is to assess the efficacy of commercially available adhesion barriers and laparoscopic adhesiolysis in preventing adhesion reformation in animal models. Pubmed and EMBASE were searched for studies which assessed peritoneal adhesion reformation after a standardized peritoneal injury (in the absence of an intra-peritoneal mesh), and reported the incidence of adhesions, or an adhesion score as outcome. Ninety-three studies were included. No study met the criteria for low risk of bias. None of the commercially available adhesion barriers significantly reduced the incidence of adhesion reformation. Three commercially available adhesion barriers reduced the adhesion score of reformed adhesions, namely Seprafilm (SMD 1.38[95% CI]; p < 0.01), PEG (SMD 2.08[95% CI]; p < 0.01) and Icodextrin (SMD 1.85[95% CI]; p < 0.01). There was no difference between laparoscopic or open adhesiolysis with regard to the incidence of adhesion reformation (RR 1.14[95% CI]; p ≥ 0.05) or the adhesion score (SMD 0.92[95% CI]; p ≥ 0.05). Neither currently commercially available adhesion barriers, nor laparoscopic adhesiolysis without using an adhesion barrier, reduces the incidence of adhesion reformation in animal models. The methodological quality of animal studies is poor.


2017 ◽  
Vol 52 (1) ◽  
pp. 79-87 ◽  
Author(s):  
Aren Bezdjian ◽  
Sjaak F L Klis ◽  
Jeroen P M Peters ◽  
Wilko Grolman ◽  
Inge Stegeman

Research involving animal models is crucial for the advancement of science, provided that experiments are designed, performed, interpreted, and reported well. In order to investigate the quality of reporting of articles in otorhinolaryngology research using animal models, a PubMed database search was conducted to retrieve eligible articles. The checklist of the ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines was used to assess the quality of reporting of articles published in ear, nose and throat (ENT) and multidisciplinary journals. Two authors screened titles, abstracts, and full texts to select articles reporting otorhinolaryngology research using in vivo animal models. ENT journals ( n = 35) reported a mean of 57.1% adequately scored ARRIVE items (median: 58.3%; 95% confidence interval [CI; 53.4–60.9%]), while articles published in multidisciplinary journals ( n = 36) reported a mean of 49.1% adequately scored items (median: 50.0; 95% CI [46.2–52.0%]). Articles published in ENT journals showed better quality of reporting of animal studies based on the ARRIVE guidelines ( P < 0.05). However, adherence to the ARRIVE guidelines is generally poor in otorhinolaryngology research using in vivo animal models. The endorsement of the ARRIVE guidelines by authors, research and academic institutes, editorial offices and funding agencies is recommended for improved reporting of scientific research using animal models.


2019 ◽  
Author(s):  
Weiyi Zhang ◽  
Yanbiao Jiang ◽  
Zhizhong Shang ◽  
Nan Zhang ◽  
Gongcai Tao ◽  
...  

AbstractObjectiveTo assess the methodological quality of animal studies published in China and abroad using the SYRCLE’s risk of bias tool, and to provide references to improve the methodological quality of animal studies to encourage high quality preclinical studies.MethodsAn electronic search was performed in the Chinese Scientific Citation Database (CSCD) and Web of Science from 2014 to October 2018. Document screening and data extraction were performed independently by four researchers. The methodological quality of the included studies was assessed using the SYRCLE’s risk of bias tool. Statistical analysis was performed using SPSS23.ResultsA total of 2764 animal studies were included. Of the studies, 984 were published in English and 1780 were in Chinese. The citation frequency of more than 90% of the included studies was less than 5. The results of methodological quality assessment showed that 36.36% (8/22) of the sub-items were rated as “low risk” in more than 50% of the included studies, of which 75% (6/8) were rated as “low risk” in more than 80% of the included studies. A total of 59.09% (13/22) of the sub-items were rated as “low risk” in less than 30% of the included studies, of which 92.31% (12/13) were rated as “low risk” in less than 10% of the included studies. The incidence of “low risk” Chinese studies regarding performance bias, detection bias and reporting bias were lower than English studies. For foreign studies, more attention should be paid to selection bias, attrition bias, and reporting bias.ConclusionWe identified limitations in the methodological quality of animal experiment studies published in China and abroad. We therefore suggest that it is necessary to take targeted measures to popularize the SYRCLE’s risk of bias tool to effectively improve the design and implementation of animal experiments, and guide study development.


2021 ◽  
Vol 5 (1) ◽  
pp. 129-139
Author(s):  
Hasan Baharun ◽  
Hefniy Hefniy ◽  
Silviani Silviani ◽  
Muhammad Anas Maarif ◽  
Adi Wibowo

This study aims to analyze and understand about analyzing the knowledge sharing strategy carried out by SMA Nurul Jadid, Paiton, Probolinggo in improving the quality of its human resources. This research uses a qualitative approach to the type of case study. Data collection techniques are carried out through interviews, observation, and documentation. Data analysis was carried out through display data, data reduction and conclusion drawing. The results showed that the strategy to improve the quality of human resources through knowledge sharing at SMA Nurul Jadid was carried out through; utilize materials, talk space, knowledge sharing culture, benchmarking best practices.


Author(s):  
Francesco Amadeo ◽  
Katherine Trivino Cepeda ◽  
James Littlewood ◽  
Bettina Wilm ◽  
Arthur Taylor ◽  
...  

Mesenchymal stromal cells (MSCs) have been found to be safe and effective in a wide range of animal models of human disease. MSCs have been tested in thousands of clinical trials, but results show that while these cells appear to be safe, they tend to lack efficacy. This has raised questions about whether animal models are useful for predicting efficacy in patients. However, a problem with animal studies is that there is a lack of standardisation in the models and MSC therapy regimes used; there appears to be publication bias towards studies reporting positive outcomes; and the reproducibility of results from animal experiments tends not to be confirmed prior to clinical translation. A further problem is that while some progress has been made towards investigating the mechanisms of action (MoA) of MSCs, we still fail to understand how they work. To make progress, it is important to ensure that prior to clinical translation, the beneficial effects of MSCs in animal studies are real and can be repeated by independent research groups. We also need to understand the MoA of MSCs to assess whether their effects are likely to be beneficial across different species. In this review, we give an overview of the current clinical picture of MSC therapies and discuss what we have learned from animal studies. We also give a comprehensive update of what we know about the MoA of MSCs, particularly in relation to their role in immunomodulation.


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