Defining gestational thyroid dysfunction through modified non-pregnancy reference intervals: an individual participant meta-analysis
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 (2024-07-31)
Oxford University Press
31.07.2024
Joris A J Osinga, Scott M Nelson, John P Walsh, Ghalia Ashoor, Glenn E Palomaki, Abel López-Bermejo, Judit Bassols, Ashraf Aminorroaya, Maarten A C Broeren, Liangmiao Chen, Xuemian Lu, Suzanne J Brown, Flora Veltri, Kun Huang, Tuija Männistö, Marina Vafeiadi, Peter N Taylor, Fang-Biao Tao, Lida Chatzi, Maryam Kianpour, Eila Suvanto, Elena N Grineva, Kypros H Nicolaides, Mary E D'Alton, Kris G Poppe, Erik Alexander, Ulla Feldt-Rasmussen, Sofie Bliddal, Polina V Popova, Layal Chaker, W Edward Visser, Robin P Peeters, Arash Derakhshan, Tanja G M Vrijkotte, Victor J M Pop, Tim I M Korevaar, Defining gestational thyroid dysfunction through modified non-pregnancy reference intervals: an individual participant meta-analysis, The Journal of Clinical Endocrinology & Metabolism, 2024;, dgae528, https://doi.org/10.1210/clinem/dgae528
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© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society. This is an Open Access article distributed under the terms of the Creative Commons Attribution -NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. See the journal About page for additional terms.
https://creativecommons.org/licenses/by-nc-nd/4.0/
© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society. This is an Open Access article distributed under the terms of the Creative Commons Attribution -NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. See the journal About page for additional terms.
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:oulu-202408215517
https://urn.fi/URN:NBN:fi:oulu-202408215517
Tiivistelmä
Abstract
Background:
Establishing local trimester-specific reference intervals for gestational TSH and FT4 is often not feasible, necessitating alternative strategies. We aimed to systematically quantify the diagnostic performance of standardized modifications of center-specific non-pregnancy reference intervals as compared to trimester-specific reference intervals.
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 non-pregnancy reference intervals included an absolute modification (per 0.1 mU/L TSH or 1 pmol/L FT4), relative modification (in steps of 5%) and fixed limits (upper TSH limit between 3.0 to 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 aforementioned 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 0.70, confidence interval [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. Confidence intervals were wide, limiting generalizability.
Conclusion:
We could not identify modifications of non-pregnancy TSH and FT4 reference intervals that would enable centers to adequately approximate trimester-specific reference intervals. Future efforts should be turned towards studying the meaningfulness of trimester-specific reference intervals and risk-based decision limits.
Background:
Establishing local trimester-specific reference intervals for gestational TSH and FT4 is often not feasible, necessitating alternative strategies. We aimed to systematically quantify the diagnostic performance of standardized modifications of center-specific non-pregnancy reference intervals as compared to trimester-specific reference intervals.
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 non-pregnancy reference intervals included an absolute modification (per 0.1 mU/L TSH or 1 pmol/L FT4), relative modification (in steps of 5%) and fixed limits (upper TSH limit between 3.0 to 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 aforementioned 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 0.70, confidence interval [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. Confidence intervals were wide, limiting generalizability.
Conclusion:
We could not identify modifications of non-pregnancy TSH and FT4 reference intervals that would enable centers to adequately approximate trimester-specific reference intervals. Future efforts should be turned towards studying the meaningfulness of trimester-specific reference intervals and risk-based decision limits.
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