Prospective comparison of diagnostic tests for bile acid diarrhoea
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Prospective comparison of diagnostic tests for bile acid diarrhoea. / Borup, Christian; Vinter-Jensen, Lars; Jørgensen, Søren Peter German; Wildt, Signe; Graff, Jesper; Gregersen, Tine; Zaremba, Anna; Andersen, Trine Borup; Nøjgaard, Camilla; Timm, Hans Bording; Lamazière, Antonin; Rainteau, Dominique; Hansen, Svend Høime; Rumessen, Jüri Johannes; Munck, Lars Kristian.
I: Alimentary Pharmacology and Therapeutics, Bind 59, Nr. 1, 2024, s. 39-50.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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T1 - Prospective comparison of diagnostic tests for bile acid diarrhoea
AU - Borup, Christian
AU - Vinter-Jensen, Lars
AU - Jørgensen, Søren Peter German
AU - Wildt, Signe
AU - Graff, Jesper
AU - Gregersen, Tine
AU - Zaremba, Anna
AU - Andersen, Trine Borup
AU - Nøjgaard, Camilla
AU - Timm, Hans Bording
AU - Lamazière, Antonin
AU - Rainteau, Dominique
AU - Hansen, Svend Høime
AU - Rumessen, Jüri Johannes
AU - Munck, Lars Kristian
N1 - Publisher Copyright: © 2023 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.
PY - 2024
Y1 - 2024
N2 - Background: Bile acid diarrhoea is often missed because gold standard nuclear medicine tauroselcholic [75-Se] acid (SeHCAT) testing has limited availability. Empirical treatment effect has unknown diagnostic performance, whereas plasma 7α-hydroxy-4-cholesten-3-one (C4) is inexpensive but lacks sensitivity. Aims: To determine diagnostic characteristics of empirical treatment and explore improvements in diagnostics with potential better availability than SeHCAT. Methods: This diagnostic accuracy study was part of a randomised, placebo-controlled trial of colesevelam. Consecutive patients with chronic diarrhoea attending SeHCAT had blood and stool sampled. Key thresholds were C4 > 46 ng/mL and SeHCAT retention ≤10%. A questionnaire recorded patient-reported empirical treatment effect. We analysed receiver operating characteristics and explored machine learning applied logistic regression and decision tree modelling with internal validation. Results: Ninety-six (38%) of 251 patients had SeHCAT retention ≤10%. The effect of empirical treatment assessed with test results for bile acid studies blinded had 63% (95% confidence interval 44%–79%) sensitivity and 65% (47%–80%) specificity; C4 > 46 ng/mL had 47% (37%–57%) and 92% (87%–96%), respectively. A decision tree combining C4 ≥ 31 ng/mL with ≥1.1 daily watery stools (Bristol type 6 and 7) had 70% (51%–85%) sensitivity and 95% (83%–99%) specificity. The logistic regression model, including C4, the sum of measured stool bile acids and daily watery stools, had 77% (58%–90%) sensitivity and 93% (80%–98%) specificity. Conclusions: Diagnosis of bile acid diarrhoea using empirical treatment was inadequate. Exploration suggested considerable improvements in the sensitivity of C4-based testing, offering potential widely available diagnostics. Further validation is warranted. ClinicalTrials.gov: NCT03876717.
AB - Background: Bile acid diarrhoea is often missed because gold standard nuclear medicine tauroselcholic [75-Se] acid (SeHCAT) testing has limited availability. Empirical treatment effect has unknown diagnostic performance, whereas plasma 7α-hydroxy-4-cholesten-3-one (C4) is inexpensive but lacks sensitivity. Aims: To determine diagnostic characteristics of empirical treatment and explore improvements in diagnostics with potential better availability than SeHCAT. Methods: This diagnostic accuracy study was part of a randomised, placebo-controlled trial of colesevelam. Consecutive patients with chronic diarrhoea attending SeHCAT had blood and stool sampled. Key thresholds were C4 > 46 ng/mL and SeHCAT retention ≤10%. A questionnaire recorded patient-reported empirical treatment effect. We analysed receiver operating characteristics and explored machine learning applied logistic regression and decision tree modelling with internal validation. Results: Ninety-six (38%) of 251 patients had SeHCAT retention ≤10%. The effect of empirical treatment assessed with test results for bile acid studies blinded had 63% (95% confidence interval 44%–79%) sensitivity and 65% (47%–80%) specificity; C4 > 46 ng/mL had 47% (37%–57%) and 92% (87%–96%), respectively. A decision tree combining C4 ≥ 31 ng/mL with ≥1.1 daily watery stools (Bristol type 6 and 7) had 70% (51%–85%) sensitivity and 95% (83%–99%) specificity. The logistic regression model, including C4, the sum of measured stool bile acids and daily watery stools, had 77% (58%–90%) sensitivity and 93% (80%–98%) specificity. Conclusions: Diagnosis of bile acid diarrhoea using empirical treatment was inadequate. Exploration suggested considerable improvements in the sensitivity of C4-based testing, offering potential widely available diagnostics. Further validation is warranted. ClinicalTrials.gov: NCT03876717.
U2 - 10.1111/apt.17739
DO - 10.1111/apt.17739
M3 - Journal article
C2 - 37794830
AN - SCOPUS:85173537905
VL - 59
SP - 39
EP - 50
JO - Alimentary Pharmacology and Therapeutics, Supplement
JF - Alimentary Pharmacology and Therapeutics, Supplement
SN - 0953-0673
IS - 1
ER -
ID: 382439004