Pub Date : 2024-12-01Epub Date: 2024-09-23DOI: 10.1177/00236772241244527
Ismene A Dontas, Derek J Fry, David I Lewis, Kenneth Applebee, Martje Fentener van Vlissingen, Katerina Marinou, Johannes Schenkel
This document provides assessment criteria for evaluation of each of the Learning Outcomes of the Modules specified (in addition to the Core Modules) for those designing procedures and projects in the Education and Training Framework guidance document by the European Commission and endorsed by the Member States Competent Authorities. This Working Group was tasked to produce these criteria by the Education & Training Platform for Laboratory Animal Science, which was funded by the European Commission to this aim. The assessment criteria address knowledge and skills (including critical thinking) expected to be acquired during education and training of persons preparing to design research procedures and projects using animals under the scope of Directive 2010/63/EU. Recognizing the diversity of expertise and experiences of those being educated and trained, we provide two levels of attainment, an ideal response and one that would be acceptable for each Learning Outcome. The balance between ideal and acceptable could be decided by the particular course providers and/or assessors, according to their local requirements. We envisage that the use of these assessment criteria by training providers and accrediting or approving bodies will help harmonize the education and training for those who will design procedures and projects using animals for scientific purposes. In Europe, this may also contribute to mutual recognition of training, and facilitate free movement of scientists.
{"title":"Guidance on the assessment of learning outcomes for those designing procedures and projects - Report of an ETPLAS Working Group.","authors":"Ismene A Dontas, Derek J Fry, David I Lewis, Kenneth Applebee, Martje Fentener van Vlissingen, Katerina Marinou, Johannes Schenkel","doi":"10.1177/00236772241244527","DOIUrl":"10.1177/00236772241244527","url":null,"abstract":"<p><p>This document provides assessment criteria for evaluation of each of the Learning Outcomes of the Modules specified (in addition to the Core Modules) for those designing procedures and projects in the Education and Training Framework guidance document by the European Commission and endorsed by the Member States Competent Authorities. This Working Group was tasked to produce these criteria by the Education & Training Platform for Laboratory Animal Science, which was funded by the European Commission to this aim. The assessment criteria address knowledge and skills (including critical thinking) expected to be acquired during education and training of persons preparing to design research procedures and projects using animals under the scope of Directive 2010/63/EU. Recognizing the diversity of expertise and experiences of those being educated and trained, we provide two levels of attainment, an ideal response and one that would be acceptable for each Learning Outcome. The balance between ideal and acceptable could be decided by the particular course providers and/or assessors, according to their local requirements. We envisage that the use of these assessment criteria by training providers and accrediting or approving bodies will help harmonize the education and training for those who will design procedures and projects using animals for scientific purposes. In Europe, this may also contribute to mutual recognition of training, and facilitate free movement of scientists.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":" ","pages":"626-639"},"PeriodicalIF":1.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633073/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142290373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-08-19DOI: 10.1177/00236772241252551
Martin D Burkhalter, Melanie Philipp
To carry out research with genetically modified animals, their genotype has to be assessed. A standard protocol to obtain required tissue samples from zebrafish is finclipping. However, some studies reported considerable stress induced by this protocol. We therefore assessed ventilation as a read-out for stress in zebrafish that underwent finclipping during routine genotyping in our fish facility. Our analysis could not confirm a strong increase of ventilation as had been previously reported. Instead, handled zebrafish showed ventilation rates in the range of controls that remained in their holding tanks. Additionally, we detected a slight reduction of ventilation rates up to an hour after anaesthesia in zebrafish treated with tricaine only, suggesting a prolonged protecting effect by this anaesthetic.
{"title":"Fin clipping does not increase opercular beat rate in tricaine-treated zebrafish.","authors":"Martin D Burkhalter, Melanie Philipp","doi":"10.1177/00236772241252551","DOIUrl":"10.1177/00236772241252551","url":null,"abstract":"<p><p>To carry out research with genetically modified animals, their genotype has to be assessed. A standard protocol to obtain required tissue samples from zebrafish is finclipping. However, some studies reported considerable stress induced by this protocol. We therefore assessed ventilation as a read-out for stress in zebrafish that underwent finclipping during routine genotyping in our fish facility. Our analysis could not confirm a strong increase of ventilation as had been previously reported. Instead, handled zebrafish showed ventilation rates in the range of controls that remained in their holding tanks. Additionally, we detected a slight reduction of ventilation rates up to an hour after anaesthesia in zebrafish treated with tricaine only, suggesting a prolonged protecting effect by this anaesthetic.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":" ","pages":"616-620"},"PeriodicalIF":1.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142000312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-08-19DOI: 10.1177/00236772241249783
Jessica L Pinckard, Lauren A Gibson, Wendy R Williams
One of the favored options for generating complex transgenic laboratory mice is through in-house breeding and management strategies. One consideration in the management of these colonies is how the animals' environment may affect reproductive success. Several aspects of the microenvironment can be controlled or manipulated, including cage type, bedding, enrichment, diet, and temperature and humidity. This study sought to evaluate reproductive outcomes for C57BL/6J mice that were randomly assigned to one of two different bedding types: paper based or corncob bedding. Our hypothesis was there would be no significant difference in reproductive outcomes between the two bedding types. A total of 10 males and 10 females were paired at 45 days of age. Animals were allowed to breed for 15 consecutive weeks. Cages were checked daily for the presence of pups and a pup count was performed at 7 days of age. Weaning occurred at 20 or 21 days of age, at which time a final pup count, pup weight, and sex were recorded. All litters born and pups weaned in the 15-week timeframe were used for data analysis. Statistical analysis compared cannibalization between the two groups and the results showed no statistical difference between groups (p > 0.05). Other parameters analyzed included average litter size, average weaning weight, and number of litters per group. All pups counted at Day 7 survived to weaning age in both groups. We concluded that both bedding types produced similar success regarding breeding fecundity in C57BL/6J mice.
{"title":"Comparison of two bedding types on the breeding fecundity of C57BL/6J mice.","authors":"Jessica L Pinckard, Lauren A Gibson, Wendy R Williams","doi":"10.1177/00236772241249783","DOIUrl":"10.1177/00236772241249783","url":null,"abstract":"<p><p>One of the favored options for generating complex transgenic laboratory mice is through in-house breeding and management strategies. One consideration in the management of these colonies is how the animals' environment may affect reproductive success. Several aspects of the microenvironment can be controlled or manipulated, including cage type, bedding, enrichment, diet, and temperature and humidity. This study sought to evaluate reproductive outcomes for C57BL/6J mice that were randomly assigned to one of two different bedding types: paper based or corncob bedding. Our hypothesis was there would be no significant difference in reproductive outcomes between the two bedding types. A total of 10 males and 10 females were paired at 45 days of age. Animals were allowed to breed for 15 consecutive weeks. Cages were checked daily for the presence of pups and a pup count was performed at 7 days of age. Weaning occurred at 20 or 21 days of age, at which time a final pup count, pup weight, and sex were recorded. All litters born and pups weaned in the 15-week timeframe were used for data analysis. Statistical analysis compared cannibalization between the two groups and the results showed no statistical difference between groups (<i>p</i> > 0.05). Other parameters analyzed included average litter size, average weaning weight, and number of litters per group. All pups counted at Day 7 survived to weaning age in both groups. We concluded that both bedding types produced similar success regarding breeding fecundity in C57BL/6J mice.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":" ","pages":"545-551"},"PeriodicalIF":1.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142000310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Outbred stocks of mice are widely used in pre-clinical research as these animals possess a diversified genetic background when compared with inbred strains of mice. It is crucial to assess particular alterations in the physiological and functional profiles of laboratory animals using haematological and biochemical indicators. These values can also differ between laboratories because they are influenced by many different factors. We aimed to provide normal values and reference intervals for selected haematology and biochemistry analytes of 570 ICR mice at three different ages: 6-8 weeks, 10-14 weeks and 6-9 months. Reference values were calculated by non-parametric methods. For comparisons between sexes, the independent-sample t-test and Mann-Whitney test were employed, and analysis of variance was used for age differences. The findings of the study revealed age-related declines in haemoglobin concentration, haematocrit, mean corpuscular volume and mean corpuscular haemoglobin concentrations. Mice aged 6-9 months had statistically higher platelet counts in their blood than mice of other ages. The white blood cell count had a significant age effect and progressively decreased with age. As mice get older, the percentage of neutrophils, monocytes and basophils increases, but the percentage of lymphocytes decreases. For the biochemical values, age-related significant differences in glucose, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and albumin concentrations were found. It was also found that creatinine concentrations were comparable across all age ranges. The values presented in the present work can be used as a reference to interpret clinical pathology data for other studies and to evaluate health status.
与近交系小鼠相比,近交系小鼠具有多样化的遗传背景,因此被广泛用于临床前研究。使用血液学和生化指标评估实验动物生理和功能特征的特定变化至关重要。由于受到许多不同因素的影响,这些数值在不同实验室之间也可能存在差异。我们的目标是为 570 只 ICR 小鼠在三个不同年龄段的选定血液学和生物化学分析指标提供正常值和参考区间:6-8周、10-14周和6-9个月。参考值采用非参数方法计算。性别间的比较采用独立样本 t 检验和曼-惠特尼检验,年龄差异采用方差分析。研究结果显示,血红蛋白浓度、血细胞比容、平均血球容积和平均血红蛋白浓度的下降与年龄有关。据统计,6-9 个月大的小鼠血液中血小板计数高于其他年龄段的小鼠。白细胞计数有明显的年龄效应,并随着年龄的增长而逐渐减少。随着小鼠年龄的增长,中性粒细胞、单核细胞和嗜碱性粒细胞的比例会增加,但淋巴细胞的比例会下降。在生化值方面,发现葡萄糖、天门冬氨酸氨基转移酶、丙氨酸氨基转移酶、碱性磷酸酶和白蛋白的浓度存在与年龄相关的显著差异。研究还发现,各年龄段的肌酐浓度相当。本研究提供的数值可作为其他研究解释临床病理学数据和评估健康状况的参考。
{"title":"Establishment of reference intervals of haematology and biochemistry analytes in ICR mice of different ages.","authors":"Suresh Patel, Satish Patel, Ashvin Kotadiya, Samir Patel, Bhavesh Shrimali, Tushar Patel, Harshida Trivedi, Vishal Patel, Jogeswar Mahapatra, Mukul Jain","doi":"10.1177/00236772241260909","DOIUrl":"10.1177/00236772241260909","url":null,"abstract":"<p><p>Outbred stocks of mice are widely used in pre-clinical research as these animals possess a diversified genetic background when compared with inbred strains of mice. It is crucial to assess particular alterations in the physiological and functional profiles of laboratory animals using haematological and biochemical indicators. These values can also differ between laboratories because they are influenced by many different factors. We aimed to provide normal values and reference intervals for selected haematology and biochemistry analytes of 570 ICR mice at three different ages: 6-8 weeks, 10-14 weeks and 6-9 months. Reference values were calculated by non-parametric methods. For comparisons between sexes, the independent-sample <i>t</i>-test and Mann-Whitney test were employed, and analysis of variance was used for age differences. The findings of the study revealed age-related declines in haemoglobin concentration, haematocrit, mean corpuscular volume and mean corpuscular haemoglobin concentrations. Mice aged 6-9 months had statistically higher platelet counts in their blood than mice of other ages. The white blood cell count had a significant age effect and progressively decreased with age. As mice get older, the percentage of neutrophils, monocytes and basophils increases, but the percentage of lymphocytes decreases. For the biochemical values, age-related significant differences in glucose, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and albumin concentrations were found. It was also found that creatinine concentrations were comparable across all age ranges. The values presented in the present work can be used as a reference to interpret clinical pathology data for other studies and to evaluate health status.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":" ","pages":"565-578"},"PeriodicalIF":1.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142349385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
As a step towards implementing non-aversive handling techniques at a big mouse breeding facility in Germany, tunnel handling was introduced in a breeding unit comprising three inbred mouse strains. To assess whether tunnel handling would be feasible for the animal technicians in their everyday work and beneficial for the mice when being handled during weekly cage change only, the behaviour of tunnel- and tail-handled animals of both sexes was examined before, during and after the handling events over a period of nine weeks. Moreover, the time expenditure was compared between both handling techniques. It was possible to use the tunnel in all three mouse strains. However, the impact of the handling techniques on the behavioural parameters investigated in the present study were strain-specific. All behavioural parameters suggested that NZW mice benefited the most from tunnel handling. The results obtained from Hello Kitty and WNK mice were ambiguous, which may suggest that a brief handling session during the cage clean may have not been sufficient to habituate them to the process of handling. It took the animal technicians approximately 3 seconds longer per mouse when using a tunnel. The strain-specific results should encourage researchers to share their experiences with non-aversive handling techniques in different mouse strains, for example, along with their research articles.
{"title":"The implementation of tunnel handling in a mouse breeding facility revealed strain-specific behavioural responses.","authors":"Katharina Hohlbaum, Roswitha Merle, Ramona Warnke, Stefan Nagel-Riedasch, Christa Thöne-Reineke, Kristina Ullmann","doi":"10.1177/00236772231215077","DOIUrl":"10.1177/00236772231215077","url":null,"abstract":"<p><p>As a step towards implementing non-aversive handling techniques at a big mouse breeding facility in Germany, tunnel handling was introduced in a breeding unit comprising three inbred mouse strains. To assess whether tunnel handling would be feasible for the animal technicians in their everyday work and beneficial for the mice when being handled during weekly cage change only, the behaviour of tunnel- and tail-handled animals of both sexes was examined before, during and after the handling events over a period of nine weeks. Moreover, the time expenditure was compared between both handling techniques. It was possible to use the tunnel in all three mouse strains. However, the impact of the handling techniques on the behavioural parameters investigated in the present study were strain-specific. All behavioural parameters suggested that NZW mice benefited the most from tunnel handling. The results obtained from Hello Kitty and WNK mice were ambiguous, which may suggest that a brief handling session during the cage clean may have not been sufficient to habituate them to the process of handling. It took the animal technicians approximately 3 seconds longer per mouse when using a tunnel. The strain-specific results should encourage researchers to share their experiences with non-aversive handling techniques in different mouse strains, for example, along with their research articles.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":" ","pages":"552-564"},"PeriodicalIF":1.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633062/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139032415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-08-20DOI: 10.1177/00236772241257726
Minkyoung Sung, Soo-Eun Sung, Joo-Hee Choi, Yujeong Lee, Kyung-Ku Kang, SunHee Park, Duyeol Kim, Sijoon Lee
Although pulmonary adenomas have been reported in ICR mice, spontaneous adenomas have not been reported in mice aged ≤10 weeks. Here, we report a well-circumscribed nodule (1 mm × 1 mm) in the peripheral lesion of the left lateral lobe of a 10-week-old male ICR mouse. Histopathologic evaluation revealed a well-demarcated nodule compressing the surrounding tissue. The neoplastic cells were polygonal with indistinct cellular borders, round/oval nuclei and abundant cytoplasm. These characteristics led to the diagnosis of type II cell-derived bronchioloalveolar adenoma. Given that they are generally observed in aged laboratory animals, this case represents a rare manifestation of a spontaneous tumor in young laboratory mice before puberty.
{"title":"Spontaneous type II cell-derived bronchioloalveolar adenoma in a young ICR mouse.","authors":"Minkyoung Sung, Soo-Eun Sung, Joo-Hee Choi, Yujeong Lee, Kyung-Ku Kang, SunHee Park, Duyeol Kim, Sijoon Lee","doi":"10.1177/00236772241257726","DOIUrl":"10.1177/00236772241257726","url":null,"abstract":"<p><p>Although pulmonary adenomas have been reported in ICR mice, spontaneous adenomas have not been reported in mice aged ≤10 weeks. Here, we report a well-circumscribed nodule (1 mm × 1 mm) in the peripheral lesion of the left lateral lobe of a 10-week-old male ICR mouse. Histopathologic evaluation revealed a well-demarcated nodule compressing the surrounding tissue. The neoplastic cells were polygonal with indistinct cellular borders, round/oval nuclei and abundant cytoplasm. These characteristics led to the diagnosis of type II cell-derived bronchioloalveolar adenoma. Given that they are generally observed in aged laboratory animals, this case represents a rare manifestation of a spontaneous tumor in young laboratory mice before puberty.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":" ","pages":"621-625"},"PeriodicalIF":1.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142004525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-08-19DOI: 10.1177/00236772231219828
Mélodie Douté, Céline Monzali, Antonino Nicoletti, Giuseppina Caligiuri, Marc Clement
Urine collection can be challenging in studies involving small rodents like mice, as the actual methods of collection are anxiogenic and constrain animal welfare while having high variability in the volume of urine collected. To improve the current methods and eventually reduce the impact on the well-being of mice, we developed an innovative 3D-printed urine collection device (UCD). This two-compartment UCD is shaped to fit in classical husbandry cages and allows urine collection by spontaneous urination from two mice housed in their own cage without cross-contamination while enabling potential social interactions. We used our UCD to study the evolution of urinary parameters related to renal functions in a model of antibody-mediated chronic kidney disease. Overall, we report here a time-saving and affordable method for urine collection providing a large amount of uncontaminated urine and which we believe may improve animal welfare in comparison with other methods.
在涉及小鼠等小型啮齿类动物的研究中,尿液收集是一项具有挑战性的工作,因为实际的尿液收集方法会使小鼠产生焦虑情绪,限制动物福利,同时收集的尿液量变化很大。为了改进现有方法并最终减少对小鼠福利的影响,我们开发了一种创新的 3D 打印尿液收集装置(UCD)。这种双室尿液收集装置的形状适合传统的饲养笼,可通过饲养在各自笼子里的两只小鼠的自发排尿收集尿液,不会造成交叉感染,同时还能实现潜在的社交互动。我们利用 UCD 研究了抗体介导的慢性肾病模型中与肾功能相关的尿液参数的演变。总之,我们在此报告了一种既省时、又经济实惠的尿液收集方法,它能提供大量未受污染的尿液,与其他方法相比,我们认为这种方法可以改善动物福利。
{"title":"Refining urine collection in mice: Development of an innovative urine collection device.","authors":"Mélodie Douté, Céline Monzali, Antonino Nicoletti, Giuseppina Caligiuri, Marc Clement","doi":"10.1177/00236772231219828","DOIUrl":"10.1177/00236772231219828","url":null,"abstract":"<p><p>Urine collection can be challenging in studies involving small rodents like mice, as the actual methods of collection are anxiogenic and constrain animal welfare while having high variability in the volume of urine collected. To improve the current methods and eventually reduce the impact on the well-being of mice, we developed an innovative 3D-printed urine collection device (UCD). This two-compartment UCD is shaped to fit in classical husbandry cages and allows urine collection by spontaneous urination from two mice housed in their own cage without cross-contamination while enabling potential social interactions. We used our UCD to study the evolution of urinary parameters related to renal functions in a model of antibody-mediated chronic kidney disease. Overall, we report here a time-saving and affordable method for urine collection providing a large amount of uncontaminated urine and which we believe may improve animal welfare in comparison with other methods.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":" ","pages":"612-615"},"PeriodicalIF":1.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142000314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1177/00236772241272991
P S Verhave, R van Eenige, Iacw Tiebosch
Blinding and randomisation are important methods for increasing the robustness of pre-clinical studies, as incomplete or improper implementation thereof is recognised as a source of bias. Randomisation ensures that any known and unknown covariates introducing bias are randomly distributed over the experimental groups. Thereby, differences between the experimental groups that might otherwise have contributed to false positive or -negative results are diminished. Methods for randomisation range from simple randomisation (e.g. rolling a dice) to advanced randomisation strategies involving the use of specialised software. Blinding on the other hand ensures that researchers are unaware of group allocation during the preparation, execution and acquisition and/or the analysis of the data. This minimises the risk of unintentional influences resulting in bias. Methods for blinding require strong protocols and a team approach. In this review, we outline methods for randomisation and blinding and give practical tips on how to implement them, with a focus on animal studies.
{"title":"Methods for applying blinding and randomisation in animal experiments.","authors":"P S Verhave, R van Eenige, Iacw Tiebosch","doi":"10.1177/00236772241272991","DOIUrl":"https://doi.org/10.1177/00236772241272991","url":null,"abstract":"<p><p>Blinding and randomisation are important methods for increasing the robustness of pre-clinical studies, as incomplete or improper implementation thereof is recognised as a source of bias. Randomisation ensures that any known and unknown covariates introducing bias are randomly distributed over the experimental groups. Thereby, differences between the experimental groups that might otherwise have contributed to false positive or -negative results are diminished. Methods for randomisation range from simple randomisation (e.g. rolling a dice) to advanced randomisation strategies involving the use of specialised software. Blinding on the other hand ensures that researchers are unaware of group allocation during the preparation, execution and acquisition and/or the analysis of the data. This minimises the risk of unintentional influences resulting in bias. Methods for blinding require strong protocols and a team approach. In this review, we outline methods for randomisation and blinding and give practical tips on how to implement them, with a focus on animal studies.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":"58 5","pages":"419-426"},"PeriodicalIF":1.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142372230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1177/00236772241276806
Penny S Reynolds
Statistically based experimental designs have been available for over a century. However, many preclinical researchers are completely unaware of these methods, and the success of experiments is usually equated only with 'p < 0.05'. By contrast, a well-thought-out experimental design strategy provides data with evidentiary and scientific value. A value-based strategy requires implementation of statistical design principles coupled with basic project management techniques. This article outlines the three phases of a value-based design strategy: proper framing of the research question, statistically based operationalisation through careful selection and structuring of appropriate inputs, and incorporation of methods that minimise bias and process variation. Appropriate study design increases study validity and the evidentiary strength of the results, reduces animal numbers, and reduces waste from noninformative experiments. Statistically based experimental design is thus a key component of the 'Reduction' pillar of the 3R (Replacement, Reduction, Refinement) principles for ethical animal research.
{"title":"Study design: think 'scientific value' not '<i>p</i>-values'.","authors":"Penny S Reynolds","doi":"10.1177/00236772241276806","DOIUrl":"https://doi.org/10.1177/00236772241276806","url":null,"abstract":"<p><p>Statistically based experimental designs have been available for over a century. However, many preclinical researchers are completely unaware of these methods, and the success of experiments is usually equated only with '<i>p</i> < 0.05'. By contrast, a well-thought-out experimental design strategy provides data with evidentiary and scientific value. A value-based strategy requires implementation of statistical design principles coupled with basic project management techniques. This article outlines the three phases of a value-based design strategy: proper framing of the research question, statistically based operationalisation through careful selection and structuring of appropriate inputs, and incorporation of methods that minimise bias and process variation. Appropriate study design increases study validity and the evidentiary strength of the results, reduces animal numbers, and reduces waste from noninformative experiments. Statistically based experimental design is thus a key component of the 'Reduction' pillar of the 3R (Replacement, Reduction, Refinement) principles for ethical animal research.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":"58 5","pages":"404-410"},"PeriodicalIF":1.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142372232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-09-24DOI: 10.1177/00236772241276785
Reid D Landes
Cage effects: some researchers worry about them, some don't, and some aren't even aware of them. When statistical analyses do not account for cage effects, there is real reason to worry. Regardless of researchers' worries or lack thereof, all researchers should be aware of how cage effects can affect the results. The "how" depends, in part, on the experimental design. Here, I (a) define cage effects; (b) illustrate a completely randomized design (CRD) often used in animal experiments; (c) explain how statistical significance is artificially inflated when cage effects are ignored and (d) give guidance on proper analyses and on how to increase statistical power in CRDs.
{"title":"How cage effects can hurt statistical analyses of completely randomized designs.","authors":"Reid D Landes","doi":"10.1177/00236772241276785","DOIUrl":"10.1177/00236772241276785","url":null,"abstract":"<p><p>Cage effects: some researchers worry about them, some don't, and some aren't even aware of them. When statistical analyses do <i>not</i> account for cage effects, there is real reason to worry. Regardless of researchers' worries or lack thereof, all researchers should be aware of <i>how</i> cage effects can affect the results. The \"how\" depends, in part, on the experimental design. Here, I (a) define cage effects; (b) illustrate a completely randomized design (CRD) often used in animal experiments; (c) explain how statistical significance is artificially inflated when cage effects are ignored and (d) give guidance on proper analyses and on how to increase statistical power in CRDs.</p>","PeriodicalId":18013,"journal":{"name":"Laboratory Animals","volume":" ","pages":"476-480"},"PeriodicalIF":1.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12352368/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}