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The Impact of Subclinical Hypothyroidism on the Quality of Life During Pregnancy: Mapping 5-Level Version of EQ-5D and ThyPRO-39
J. Tuzil, BF. Pilnackova, T. Watt, J. Jiskra, M. Koudelkova, E. Novotna, K. Tuzilova, T. Dolezal, J. Bartakova
Language English Country United States
Document type Clinical Study, Journal Article
- MeSH
- Adult MeSH
- Hypothyroidism * MeSH
- Quality of Life * psychology MeSH
- Humans MeSH
- Surveys and Questionnaires MeSH
- Pregnancy MeSH
- Thyrotropin MeSH
- Anxiety MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Study MeSH
OBJECTIVES: To describe how subclinical hypothyroidism (SubHypo) influences the quality of life (QoL) during pregnancy. METHODS: In primary data collection (NCT04167423), thyroid stimulating hormone (TSH), free thyroxine (FT4), thyroid peroxidase antibodies, generic quality of life (QoL; 5-level version of EQ-5D [EQ-5D-5L]), and disease-specific QoL (ThyPRO-39) were measured among pregnant women. SubHypo during each trimester was defined according to the 2014 European Thyroid Association guidelines (TSH > 2.5, 3.0, and 3.5 IU/L, respectively; with normal FT4). Path analysis described relationships and tested mediation. Linear ordinary least squares, beta, tobit, and two-part regressions were used to map ThyPRO-39 and EQ-5D-5L. Alternative SubHypo definition was tested in sensitivity analysis. RESULTS: A total of 253 women at 14 sites (31 ± 5 years old, 15 ± 6 weeks pregnant) completed the questionnaires. Sixty-one (26%) had SubHypo and differed from 174 (74%) euthyroid women in smoking history (61% vs 41%), primiparity (62% vs 43%) and TSH level (4.1 ± 1.4 vs 1.5 ± 0.7 mIU/L, P < .001). EQ-5D-5L utility in SubHypo (0.89 ± 0.12) was lower than that in euthyroid (0.92 ± 0.11; P = .028) even after adjustment (difference -0.04, P = .033), whereas ocular (P = .001, ThyPRO-39), cognitive symptoms (P = .043), anxiety (P < .0001), and the composite score were higher. The impact of SubHypo on utility was mediated by anxiety. Results were confirmed by sensitivity analysis. Final mapping equation (ordinary least squares) includes goiter symptoms, anxiety, upset stomach, composite score (ThyPRO-39), FT4 levels, and week of pregnancy (determination coefficient 0.36). CONCLUSION: This is the first QoL mapping of SubHypo during pregnancy and the first evidence that SubHypo is associated with a negative impact on QoL. The effect is mediated by anxiety. EQ-5D-5L utilities can be generated based on ThyPRO-39 scores collected in pregnant euthyroid and patients with SubHypo.
1st Medical Faculty Charles University Prague Czech Republic
Department of Internal Medicine Endocrinology Herlev Gentofte Hospital Copenhagen Denmark
Department of Pharmacology Faculty of Medicine Masaryk University Brno Czech Republic
GYNO SANET s r o Prague Czech Republic
Health Economics Facility Department of Public Health University of Basel Basel Switzerland
Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Brno Czech Republic
Institute of Health Economics and Technology Assessment Prague Czech Republic
Outpatient gynecology Femcare s r o Odolena Voda Czech Republic
References provided by Crossref.org
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- $a Tuzil, Jan $u Institute of Health Economics and Technology Assessment, Prague, Czech Republic; First Medical Faculty, Charles University, Prague, Czech Republic. Electronic address: tuzil.jenik@gmail.com
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- $a OBJECTIVES: To describe how subclinical hypothyroidism (SubHypo) influences the quality of life (QoL) during pregnancy. METHODS: In primary data collection (NCT04167423), thyroid stimulating hormone (TSH), free thyroxine (FT4), thyroid peroxidase antibodies, generic quality of life (QoL; 5-level version of EQ-5D [EQ-5D-5L]), and disease-specific QoL (ThyPRO-39) were measured among pregnant women. SubHypo during each trimester was defined according to the 2014 European Thyroid Association guidelines (TSH > 2.5, 3.0, and 3.5 IU/L, respectively; with normal FT4). Path analysis described relationships and tested mediation. Linear ordinary least squares, beta, tobit, and two-part regressions were used to map ThyPRO-39 and EQ-5D-5L. Alternative SubHypo definition was tested in sensitivity analysis. RESULTS: A total of 253 women at 14 sites (31 ± 5 years old, 15 ± 6 weeks pregnant) completed the questionnaires. Sixty-one (26%) had SubHypo and differed from 174 (74%) euthyroid women in smoking history (61% vs 41%), primiparity (62% vs 43%) and TSH level (4.1 ± 1.4 vs 1.5 ± 0.7 mIU/L, P < .001). EQ-5D-5L utility in SubHypo (0.89 ± 0.12) was lower than that in euthyroid (0.92 ± 0.11; P = .028) even after adjustment (difference -0.04, P = .033), whereas ocular (P = .001, ThyPRO-39), cognitive symptoms (P = .043), anxiety (P < .0001), and the composite score were higher. The impact of SubHypo on utility was mediated by anxiety. Results were confirmed by sensitivity analysis. Final mapping equation (ordinary least squares) includes goiter symptoms, anxiety, upset stomach, composite score (ThyPRO-39), FT4 levels, and week of pregnancy (determination coefficient 0.36). CONCLUSION: This is the first QoL mapping of SubHypo during pregnancy and the first evidence that SubHypo is associated with a negative impact on QoL. The effect is mediated by anxiety. EQ-5D-5L utilities can be generated based on ThyPRO-39 scores collected in pregnant euthyroid and patients with SubHypo.
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