4.14 Guest Lecture – Subclinical Hypothyroidism and TSH – New Insights on TSH Reference Values

Background. Subclinical hypothyroidism during pregnancy and gestational diabetes mellitus (GDM) is known to be associated with maternal and child morbidity. The concept of subclinical dysfunction of the thyroid gland in pregnant women depends on the population-specific and trimester-specific reference values so fixed universal cutoff concentrations for thyroid-stimulating hormone (TSH) that were recommended earlier now are put under the question. Population-specific and trimester-specific reference values have not been defined for pregnant women residing in Saint Petersburg. The data concerning the association of maternal thyroid status with GDM development are controversial. Aims. The aim of the study was to determine the reference values of TSH and free thyroxin (fT4) in the first trimester of pregnancy in women living in St. Petersburg, and to assess the relationship between thyroid status and the risk of subsequent development of GDM. Materials and methods. The levels of TSH, fT4 and thyroid peroxidase antibodies (TPO-Ab) were analyzed in 503 pregnant women before the 14th week of gestation. The women underwent oral glucose tolerance test (OGTT) at 2428 weeks to find out those with GDM. The association between thyroid function, thyroid autoimmunity and the risk of GDM we estimated. Results. The reference values for TSH were 0.07 4.40 mU /L, and for fT4 11.7 20.3 pmol/L. The prevalence of subclinical hypothyroidism in the 503 pregnant women was 16.9% according to the diagnostic criteria of TSH 2.5 mIU / L and 3.8% using our calculated reference interval. Hypothyroxinemia was registered in 5,3% using reference values recommended by diagnostic tests manufacturer and in 2,8% according to our calculated reference interval for fT4. GDM was diagnosed in 23% of women. Logistic regression analysis showed associations of hypothyroxinemia and TPO-Ab-positivity with the increased risk of GDM that remained significant after adjustments on age and body mass index (BMI) [adjusted OR (95% CI) = 7.39 (1.2742.93) for hypothyroxinemia, p=0.026; and adjusted OR (95% CI) = 2.02 (1.014.04) for TPO-Ab-positivity, p=0.047). Conclusions. Reference intervals for first trimester TSH and fT4 have been established for pregnant women living in St. Petersburg. Hypothyroxinemia and TPO-Ab-positivity were associated with the increased risk of GDM.

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Subclinical hypothyroidism: a ‘laboratory-induced’ condition?

Acta Endocrinologica ◽

10.1530/eje-15-0684 ◽

2015 ◽

Vol 173 (4) ◽

pp. 499-505 ◽

Cited By ~ 5

Author(s):

Karlien L M Coene ◽

Ayse Y Demir ◽

Maarten A C Broeren ◽

Pauline Verschuure ◽

Eef G W M Lentjes ◽

...

Keyword(s):

Reference Values ◽

Subclinical Hypothyroidism ◽

Analytical Method ◽

Clinical Decision Making ◽

Clinical Decision ◽

Reference Intervals ◽

Reference Ranges ◽

Thyroid Pathology ◽

Design And Methods

ObjectiveIn current literature and guidelines, there is a tendency to define absolute TSH concentrations at which patient follow-up or even pharmaceutical intervention should be initiated. As TSH concentrations depend on the analytical method/platform used for TSH quantification, absolute cut-off values may pose threats for uniform clinical decision-making. In this study we therefore set out to clarify to what extent the method/platform and the reference values applied for TSH influence the clinical interpretation of thyroid parameters.Design and methodsWe retrospectively analyzed anonymous TSH results from the Dutch external quality assessment program (EQAS) in relation to reference values advised by different manufacturers. We also examined TSH/free thyroxin (fT4) reference ranges and prevalence of thyroid pathology among different Dutch laboratories, including four cases in which a switch in the measuring platform was made.ResultsOur data show that interpretation of thyroid parameters is not only influenced by between-method/platform variation, but is also substantially affected by the variation in TSH/fT4 reference intervals applied in individual laboratories. Additionally, we show that the transition to a novel analytical method/platform can result in a shift in the prevalence of thyroid pathology, especially for subclinical hypothyroidism.ConclusionsSubclinical hypothyroidism can be a ‘laboratory-induced’ condition. This is an undesirable situation in regard to the clinical implications such a diagnosis can have for patients.

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