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European Journal of Emergency Medicine... Aug 2021
Topics: Emergency Medicine; Humans; Laboratories; Research Design; Switzerland
PubMed: 33833139
DOI: 10.1097/MEJ.0000000000000816 -
Alternatives To Laboratory Animals :... Nov 2018Recurrent acute and/or chronic stress can affect all vertebrate species, and can have serious consequences. It is increasingly and widely appreciated that laboratory... (Review)
Review
Recurrent acute and/or chronic stress can affect all vertebrate species, and can have serious consequences. It is increasingly and widely appreciated that laboratory animals experience significant and repeated stress, which is unavoidable and is caused by many aspects of laboratory life, such as captivity, transport, noise, handling, restraint and other procedures, as well as the experimental procedures applied to them. Such stress is difficult to mitigate, and lack of significant desensitisation/habituation can result in considerable psychological and physiological welfare problems, which are mediated by the activation of various neuroendocrine networks that have numerous and pervasive effects. Psychological damage can be reflected in stereotypical behaviours, including repetitive pacing and circling, and even self-harm. Physical consequences include adverse effects on immune function, inflammatory responses, metabolism, and disease susceptibility and progression. Further, some of these effects are epigenetic, and are therefore potentially transgenerational: the biology of animals whose parents/grandparents were wild-caught and/or have experienced chronic stress in laboratories could be altered, as compared to free-living individuals. It is argued that these effects must have consequences for the reliability of experimental data and their extrapolation to humans, and this may not be recognised sufficiently among those who use animals in experiments.
Topics: Animal Welfare; Animals; Laboratories; Reproducibility of Results; Research Design; Stress, Physiological
PubMed: 30488713
DOI: 10.1177/026119291804600501 -
Disease Models & Mechanisms Oct 2022In 2021, the National Institutes of Health Advisory Committee to the Director (ACD) announced recommendations to improve the reproducibility of biomedical research using...
In 2021, the National Institutes of Health Advisory Committee to the Director (ACD) announced recommendations to improve the reproducibility of biomedical research using animals. In response, The Jackson Laboratory faculty and institutional leaders identified key strategies to further address this important issue. Taking inspiration from the evolution of clinical trials over recent decades in response to similar challenges, we identified opportunities for improvement, including establishment of common standards, use of genetically diverse populations, requirement for robust study design with appropriate statistical methods, and improvement in public databases to facilitate meta-analyses. In this Perspective, we share our response to ACD recommendations, with a specific focus on mouse models, with the aim of promoting continued active dialogue among researchers, using any animal system, worldwide. Such discussion will help to inform the biomedical community about these recommendations and further support their much-needed implementation.
Topics: Animals; Biomedical Research; Humans; Laboratories; Mice; Reproducibility of Results; Research Design; Research Personnel
PubMed: 36250972
DOI: 10.1242/dmm.049775 -
International Endodontic Journal Sep 2021
Topics: Animals; Humans; Laboratories; Publishing; Research Design
PubMed: 34375456
DOI: 10.1111/iej.13568 -
Clinics in Laboratory Medicine Mar 2017A new Clinical Laboratory Improvement Amendments option for risk-based quality-control (QC) plans became effective in January, 2016. Called an Individualized QC Plan,... (Review)
Review
A new Clinical Laboratory Improvement Amendments option for risk-based quality-control (QC) plans became effective in January, 2016. Called an Individualized QC Plan, this option requires the laboratory to perform a risk assessment, develop a QC plan, and implement a QC program to monitor ongoing performance of the QC plan. Difficulties in performing a risk assessment may limit validity of an Individualized QC Plan. A better alternative is to develop a Total QC Plan including a right-sized statistical QC procedure to detect medically important errors. Westgard Sigma Rules provides a simple way to select the right control rules and the right number of control measurements.
Topics: Diagnostic Errors; Humans; Laboratories; Quality Control; Risk Assessment; Total Quality Management
PubMed: 28153361
DOI: 10.1016/j.cll.2016.09.011 -
ALTEX 2021The use of in vitro assays to inform decision-making requires robust and reproducible results across studies, laboratories, and time. Experiments using positive control...
The use of in vitro assays to inform decision-making requires robust and reproducible results across studies, laboratories, and time. Experiments using positive control materials are an integral component of an assay procedure to demonstrate the extent to which the measurement system is performing as expected. This paper reviews ten characteristics that should be considered when selecting a positive control material for an in vitro assay: 1) the biological mechanism of action, 2) ease of preparation, 3) chemical purity, 4) verifiable physical properties, 5) stability, 6) ability to generate responses spanning the dynamic range of the assay, 7) technical or biological interference, 8) commercial availability, 9) user toxicity, and 10) disposability. Examples and a case study of the monocyte activation test are provided to demonstrate the application of these characteristics for identification and selection of potential positive control materials. Because specific positive control materials are often written into testing standards for in vitro assays, selection of the positive control material based on these characteristics can aid in ensuring the long-term relevance and usability of these standards.
Topics: Biological Assay; Laboratories; Research Design
PubMed: 33637998
DOI: 10.14573/altex.2102111 -
Nature Jul 2014
Topics: Accidents; Disease Transmission, Infectious; Humans; Laboratories; Research Design; Safety Management
PubMed: 25079518
DOI: 10.1038/511507a -
Surgeon's Circular Letter. United... Mar 1949
Topics: Data Collection; Humans; Laboratories
PubMed: 18153867
DOI: No ID Found -
Analytical and Bioanalytical Chemistry Sep 2023MS-based analytical methods now play an important role in medical laboratory analysis. Predominantly triple-stage mass spectrometry is used for the quantification of...
MS-based analytical methods now play an important role in medical laboratory analysis. Predominantly triple-stage mass spectrometry is used for the quantification of small molecule biomarkers and xenobiotics in blood and urine. The spectrum of applications ranges from completely in-house developed analytical methods, to industrially manufactured kit solutions used on generic equipment, to the first closed MS-based analysis systems. It is to be expected that the weights will shift in the coming years. Thus, operation and evaluation for most applications will remain very challenging and very different from the far more user-friendly and fully automated systems - mainly photometry-based - which are commonly used in clinical laboratories. General regulatory requirements for medical analysis differ significantly between countries globally. General requirements for in-house developed assay methods are valid in some countries, but concrete and methodology-specific rules for operation and quantification when using MS methods in the medical diagnostic laboratory are not applied. This differs significantly from other bio-analytical areas such as food monitoring, pharmaceutical research, or forensics, where legally binding, detailed rules exist in some cases, e.g., for substance identification. Internationally used relevant and helpful general standards with regard to mass spectrometric examination procedures in the clinical laboratory are in particular CLSI 62A and ISO 15189, while the IVDR in the EU primarily regulates the manufacture of diagnostic articles and not their application. In addition, from many years of application experience, some general advice can be recommended as rules that can contribute to robustness and patient safety in the clinical application of MS procedures; with emphasis on: reasonable method description, batch release, competence management, maintenance, and continuity management. This article also proposes some procedural basic requirements for the application of MS procedures in the clinical laboratory.
Topics: Humans; Laboratories, Clinical; Mass Spectrometry; Reference Standards
PubMed: 36964833
DOI: 10.1007/s00216-023-04648-0 -
Appetite Jul 2021External influences on eating behaviour, such as portion size, have been reliably shown to influence food intake in the laboratory. However, little research has examined...
External influences on eating behaviour, such as portion size, have been reliably shown to influence food intake in the laboratory. However, little research has examined whether laboratory settings under or overestimate the effect that external influences have on food intake compared to when studied in the real-world. In Study 1, 60 participants (mean age = 32 years) were randomized to consume a large (200 g) or small (100 g) portion of popcorn under controlled laboratory conditions and during a separate session in their home. Results showed that the effect of portion size on food intake was larger at home (d = 0.97) than in the laboratory (d = 0.56). Furthermore, participants reported feeling more relaxed eating at home compared to the laboratory. In Study 2, we examined whether comparable results were observed in a semi-naturalistic laboratory designed to resemble a home setting. 59 participants (mean age = 28 years) completed the same procedure as Study 1 in a standard and a semi-naturalistic laboratory setting. Although participants reported having higher levels of private self-awareness in the standard laboratory, the effect that portion size had on food intake did not differ between the standard laboratory (d = 0.50) and the semi-naturalistic laboratory (d = 0.49). The impact that external influences on eating, such as portion size, have on food intake in the real-world may be underestimated when studied under laboratory conditions.
Topics: Adult; Eating; Energy Intake; Feeding Behavior; Food; Humans; Laboratories; Portion Size; Random Allocation
PubMed: 33556391
DOI: 10.1016/j.appet.2021.105160