The Impact of Subclinical Hypothyroidism on the Quality of Life During Pregnancy: Mapping 5-Level Version of EQ-5D and ThyPRO-39 |
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| Affiliation: | 1. Institute of Health Economics and Technology Assessment, Prague, Czech Republic;2. First Medical Faculty, Charles University, Prague, Czech Republic;3. Department of Internal Medicine, Endocrinology, Herlev Gentofte Hospital, Copenhagen, Denmark;4. Third Department of Internal Medicine, General University Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic;5. Institute of Health Information and Statistics of the Czech Republic, National Screening Centre, Praha, Czech Republic;6. Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic;7. Outpatient gynecology Femcare s.r.o., Odolena Voda, Czech Republic;8. GYNO SANET s.r.o., Prague, Czech Republic;9. Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic;10. Department of Public Health, Institute of Nursing Science, Faculty of Medicine, University of Basel, Basel, Switzerland;11. Health Economics Facility, Department of Public Health, University of Basel, Basel, Switzerland;1. Division of Cardiology, Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, South Korea;2. Department of Cardiology, Sungae Hospital, Seoul, South Korea;3. Division of Cardiology, Department of Internal Medicine, College of Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, South Korea;4. Division of Cardiology, Department of Internal Medicine, College of Medicine, Korea University Guro Hospital, Seoul, South Korea;5. Division of Cardiology, Department of Internal Medicine, College of Medicine, Chungnam National University Hospital, Daejeon, South Korea;6. Division of Cardiology, Department of Internal Medicine, College of Medicine, Chonnam National University Hospital, Gwangju, South Korea;7. Division of Cardiology, Department of Internal Medicine, College of Medicine, Kangwon National University Hospital, Chuncheon, South Korea;1. Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands;2. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands;3. Sanofi, Bridgewater, NJ, USA;4. Pfizer Inc, Brussels, Belgium;5. Sanofi, Chilly-Mazarin, France;6. Merck & Co, Kenilworth, NJ, USA;7. Janssen Research & Development, LLC, Titusville, NJ, USA;8. Health Technology and Services Research, Faculty of Behavioural and Management Science, University of Twente, Enschede, The Netherlands;1. Private Academic Consultant, Bangkok, Thailand;2. Department of Community Medicine, Dr DY Patil University, Pune, India;1. Erasmus Choice Modelling Centre, Erasmus University Rotterdam, Rotterdam, The Netherlands;2. Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands;3. Erasmus School of Economics, Erasmus University Rotterdam, Rotterdam, the Netherlands;1. Decision Support and Analysis Staff, Office of Program and Strategic Analysis, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA;2. Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA;3. Erasmus School of Health Policy and Management & Erasmus Choice Modelling Center, Rotterdam, The Netherlands;4. School of Health and Related Research, University of Sheffield, Sheffield, England, UK;5. Global R&D Epidemiology, Janssen R&D, Titusville, NJ, USA;6. Manchester Centre for Health Economics, School of Health Sciences, The University of Manchester, Manchester, England, UK;7. Google, San Francisco, CA, USA;8. Kielo Research, Zug, Switzerland;1. Department of Pharmacy Systems, Outcomes, and Policy, University of Illinois Chicago College of Pharmacy, Chicago, IL, USA;2. Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA;3. Center for Evaluation of Value and Risk in Health, Tufts Medical Center, Boston, MA, USA;4. Innovation and Value Initiative, Alexandria, VA, USA;5. Institute for Clinical and Economic Review, Boston, MA, USA |
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| Abstract: | ObjectivesTo describe how subclinical hypothyroidism (SubHypo) influences the quality of life (QoL) during pregnancy.MethodsIn 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.ResultsA 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).ConclusionThis 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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| Keywords: | EQ-5D hypothyroidism pregnancy quality of life ThyPRO-39 |
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