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Need for gender-specific pre-analytical testing: the dark side of the moon in laboratory testing

Franconi, Flavia and Rosano, Giuseppe and Campesi, Ilaria (2015) Need for gender-specific pre-analytical testing: the dark side of the moon in laboratory testing. International Journal of Cardiology, Vol. 179 , p. 514-535. ISSN 0167-5273. eISSN 1874-1754. Article.

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DOI: 10.1016/j.ijcard.2014.11.019

Abstract

Many international organisations encourage studies in a sex–gender perspective. However, research with a gender perspective presents a high degree of complexity, and the inclusion of sex–gender variable in experiments presents many methodological questions, the majority of which are still neglected. Overcoming these issues is fundamental to avoid erroneous results. Here, pre-analytical aspects of the research, such as study design, choice of utilised specimens, sample collection and processing, animal models of diseases, and the observer's role, are discussed. Artefacts in this stage of research could affect the predictive value of all analyses. Furthermore, the standardisation of research subjects according to their lifestyles and, if female, to their life phase and menses or oestrous cycle, is urgent to harmonise research worldwide. A sex–gender-specific attention to pre-analytical aspects could produce a decrease in the time for translation from the bench to bedside. Furthermore, sexgender-specific pre-clinical pharmacological testing will enable adequate assessment of pharmacokinetic and pharmacodynamic actions of drugs and will enable, where appropriate, an adequate gender-specific clinical development plan. Therefore, sex-gender-specific pre-clinical research will increase the gender equity of care and will produce more evidence-based medicine.

Item Type:Article
ID Code:10606
Status:Published
Refereed:Yes
Uncontrolled Keywords:Sex–gender, research complexity, pre-analytical conditions
Subjects:Area 05 - Scienze biologiche > BIO/14 Farmacologia
Divisions:001 Università di Sassari > 01-a Nuovi Dipartimenti dal 2012 > Scienze Chirurgiche, Microchirurgiche e Mediche
001 Università di Sassari > 01-a Nuovi Dipartimenti dal 2012 > Scienze Biomediche
Publisher:Elsevier
ISSN:0167-5273
eISSN:1874-1754
Copyright Holders:© 2014 Elsevier Ireland
Deposited On:13 Jan 2015 13:57

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