Defining Gestational Thyroid Dysfunction Through Modified Nonpregnancy Reference Intervals: An Individual Participant Meta-analysis.
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Osinga Joris A J, Nelson Scott M, Walsh John P, Ashoor Ghalia, Palomaki Glenn E, López-Bermejo Abel, Bassols Judit, Aminorroaya Ashraf, Broeren Maarten A C, Chen Liangmiao, Lu Xuemian, Brown Suzanne J, Veltri Flora, Huang Kun, Männistö Tuija, Vafeiadi Marina, Taylor Peter N, Tao Fang-Biao, Chatzi Lida, Kianpour Maryam, Suvanto Eila, Grineva Elena N, Nicolaides Kypros H, D'Alton Mary E, Poppe Kris G, Alexander Erik, Feldt-Rasmussen Ulla, Bliddal Sofie, Popova Polina V, Chaker Layal, Visser W Edward, Peeters Robin P, Derakhshan Arash, Vrijkotte Tanja G M, Pop Victor J M, Korevaar Tim I M
Аннотация
METHODS: We included prospective cohorts participating in the Consortium on Thyroid and Pregnancy. After relevant exclusions, reference intervals were calculated per cohort in thyroperoxidase antibody-negative women. Modifications to the nonpregnancy reference intervals included an absolute modification (per .1 mU/L TSH or 1 pmol/L free T4), relative modification (in steps of 5%) and fixed limits (upper TSH limit between 3.0 and 4.5 mU/L and lower FT4 limit 5-15 pmol/L). We compared (sub)clinical hypothyroidism prevalence, sensitivity, and positive predictive value (PPV) of these methodologies with population-based trimester-specific reference intervals.
RESULTS: The final study population comprised 52 496 participants in 18 cohorts. Optimal modifications of standard reference intervals to diagnose gestational overt hypothyroidism were -5% for the upper limit of TSH and +5% for the lower limit of FT4 (sensitivity, .70, CI, 0.47-0.86; PPV, 0.64, CI, 0.54-0.74). For subclinical hypothyroidism, these were -20% for the upper limit of TSH and -15% for the lower limit of FT4 (sensitivity, 0.91; CI, 0.67-0.98; PPV, 0.71, CI, 0.58-0.80). Absolute and fixed modifications yielded similar results. CIs were wide, limiting generalizability.
CONCLUSION: We could not identify modifications of nonpregnancy TSH and FT4 reference intervals that would enable centers to adequately approximate trimester-specific reference intervals. Future efforts should be turned toward studying the meaningfulness of trimester-specific reference intervals and risk-based decision limits.