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The BACH project pr...
The BACH project protocol: An international multicentre total Bile Acid Comparison and Harmonisation project and sub-study of the TURRIFIC randomised trial
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Markus, Corey (författare)
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Coat, Suzette (författare)
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- Marschall, Hanns-Ulrich, 1954 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine
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Williamson, Catherine (författare)
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Dixon, Peter (författare)
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Fuller, Maria (författare)
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Matthews, Susan (författare)
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Rankin, Wayne (författare)
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Metz, Michael (författare)
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Hague, William M. (författare)
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(creator_code:org_t)
- 2021-08-06
- 2021
- Engelska.
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Ingår i: Clinical Chemistry and Laboratory Medicine. - : Walter de Gruyter GmbH. - 1434-6621 .- 1437-4331. ; 59, s. 1921-1929
- Relaterad länk:
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Objectives: Multicentre international trials relying on diagnoses derived from biochemical results may overlook the importance of assay standardisation from the participating laboratories. Here we describe a study protocol aimed at harmonising results from total bile acid determinations within the context of an international randomised controlled Trial of two treatments, URsodeoxycholic acid and RIFampicin, for women with severe early onset Intrahepatic Cholestasis of pregnancy (TURRIFIC), referred to as the Bile Acid Comparison and Harmonisation (BACH) study, with the aims of reducing inter-laboratory heterogeneity in total bile acid assays. Methods: We have simulated laboratory data to determine the feasibility of total bile acid recalibration using a reference set of patient samples with a consensus value approach and subsequently used regression-based techniques to transform the data. Results: From these simulations, we have demonstrated that mathematical recalibration of total bile acid results is plausible, with a high probability of successfully harmonising results across participating laboratories. Conclusions: Standardisation of bile acid results facilitates the commutability of laboratory results and collation for statistical analysis. It may provide the momentum for broader application of the described techniques in the setting of large-scale multinational clinical trials dependent on results from non-standardised assays.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
Nyckelord
- bile acid
- cholestasis
- comparison
- computer simulation
- harmonisation
- pregnancy
- protocol
- quality assurance
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Markus, Corey
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Coat, Suzette
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Marschall, Hanns ...
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Williamson, Cath ...
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Dixon, Peter
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Fuller, Maria
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visa fler...
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Matthews, Susan
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Rankin, Wayne
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Metz, Michael
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Hague, William M ...
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Cancer och onkol ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Gastroenterologi
- Artiklar i publikationen
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Clinical Chemist ...
- Av lärosätet
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Göteborgs universitet