Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals. Issue 1 (15th April 2020)

• Record Type: Journal Article
• Authors: Vollert, Jan; Schenker, Esther; Macleod, Malcolm; Bespalov, Anton; Wuerbel, Hanno; Michel, Martin; Dirnagl, Ulrich; Potschka, Heidrun; Waldron, Ann-Marie; Wever, Kimberley; Steckler, Thomas; van de Casteele, Tom; Altevogt, Bruce; Sil, Annesha; Rice, Andrew S C
• Other Names: author non-byline.; Vollert Jan author non-byline.; Schenker Esther author non-byline.; Macleod Malcolm author non-byline.; Clark Judi author non-byline.; Sena Emily author non-byline.; Bespalov Anton author non-byline.; Boulanger Bruno author non-byline.; Riedel Gernot author non-byline.; Platt Bettina author non-byline.; Sil Annesha author non-byline.; Kas Martien J author non-byline.; Wuerbel Hanno author non-byline.; Voelkl Bernhard author non-byline.; Michel Martin C author non-byline.; Jucker Mathias author non-byline.; Wegenast-Braun Bettina M author non-byline.; Dirnagl Ulrich author non-byline.; Bernard René author non-byline.; Heiden Esmeralda author non-byline.; Potschka Heidrun author non-byline.; Loos Maarten author non-byline.; Wever Kimberley E author non-byline.; Ritskes-Hoitinga Merel author non-byline.; Casteele Tom Van De author non-byline.; Steckler Thomas author non-byline.; Drinkenburg Pim author non-byline.; Pita Almenar Juan Diego author non-byline.; Gallacher David author non-byline.; Linde Henk Van Der author non-byline.; Gilis Anja author non-byline.; Teuns Greet author non-byline.; Wicke Karsten author non-byline.; Grote Sabine author non-byline.; Sommer Bernd author non-byline.; Nicholson Janet author non-byline.; Janhunen Sanna author non-byline.; Virtanen Sami author non-byline.; Altevogt Bruce author non-byline.; Cheng Kristin author non-byline.; Ramboz Sylvie author non-byline.; Leahy Emer author non-byline.; Lefevre Isabel A author non-byline.; Ducrey Fiona author non-byline.; Guillen Javier author non-byline.; Vergara Patri author non-byline.; Waldron Ann-Marie author non-byline.; Seiffert Isabel author non-byline.; Rice Andrew S C author non-byline.;
• Is Part Of: BMJ open science. Volume 4:Issue 1(2020)
• Publication Date: 2020-04-15
• Subjects: scientific rigor -- bias -- internal validity -- preclinical studies -- animal studies; Medical sciences -- Periodicals; Medical sciences -- Research -- Periodicals; 610.5
• DOI: 10.1136/bmjos-2019-100046
• Languages: English
• ISSNs: 2398-8703

Abstract

Abstract : Over the last two decades, awareness of the negative repercussions of flaws in the planning, conduct and reporting of preclinical research involving experimental animals has been growing. Several initiatives have set out to increase transparency and internal validity of preclinical studies, mostly publishing expert consensus and experience. While many of the points raised in these various guidelines are identical or similar, they differ in detail and rigour. Most of them focus on reporting, only few of them cover the planning and conduct of studies. The aim of this systematic review is to identify existing experimental design, conduct, analysis and reporting guidelines relating to preclinical animal research. A systematic search in PubMed, Embase and Web of Science retrieved 13 863 unique results. After screening these on title and abstract, 613 papers entered the full-text assessment stage, from which 60 papers were retained. From these, we extracted unique 58 recommendations on the planning, conduct and reporting of preclinical animal studies. Sample size calculations, adequate statistical methods, concealed and randomised allocation of animals to treatment, blinded outcome assessment and recording of animal flow through the experiment were recommended in more than half of the publications. While we consider these recommendations to be valuable, there is a striking lack of experimental evidence on their importance and relative effect on experiments and effect sizes.