Abstract
Adverse effects of overt maternal hypothyroidism on pregnancy and child developmental outcomes are well documented (1 –3). Most hypothyroid pregnant women taking levothyroxine (LT4) require a 25–30% LT4 dose increase to maintain euthyroidism (4). Therefore, clinicians need to counsel reproductive-age women regarding the need for adequate thyroid hormone replacement therapy (THRT) and thyroid function monitoring during pregnancy. Previous studies assessed pregnant women's medication adherence (5), their emotive response to hypothyroidism diagnosis (6), and physician perspective (7,8). Our cross-sectional survey-based assessment is the first to examine patient-reported rates and sources of preconception THRT counseling.
An anonymous survey questionnaire, approved by the Boston University Medical Campus Institutional Review Board, was electronically sent to Friends of the American Thyroid Association (ATA) newsletter subscribers and to ATA members for patient distribution between March 12, 2020 and May 18, 2020, with a one-month reminder. Women aged 18–50 years with diagnosed hypothyroidism were included. Demographics and information regarding pregnancy status, types of treating clinician and thyroid hormone prescribed, THRT counseling, and, if applicable, hypothyroidism management during pregnancy were collected. Chi-square tests were used to assess univariate associations, using SAS version 9.3 (SAS Institute, Inc., Cary, NC, USA). A two-tailed p-value <0.05 was considered statistically significant.
Of 348 responses received, 192 were excluded (5 lacked consent, 43 not female, 109 outside the age criteria, 18 without hypothyroidism, and 17 incomplete surveys). A total of 156 responses (11 with missing values) were included in the study. Patient characteristics and treatment patterns are presented in Table 1.
Characteristics and Treatment Patterns of Study Participants
Pakistan, Canada (2), Australia, and United Kingdom.
Mexico, Serbia, Switzerland, Australia (2), Costa Rica, and Canada.
Spain, South Africa, Mexico, Costa Rica, Argentina, Austria, Australia, and Netherlands.
Currently nonpregnant state for previously pregnant and never-pregnant women.
T4 and desiccated thyroid hormone.
T4 and desiccated thyroid hormone; T4, T3, and desiccated thyroid hormone.
Natural supplements.
OBGYN/other (general practitioner) (1), endocrinologist/internal medicine (2), endocrinologist/OBGYN (3), endocrinologist/OBGYN/FM (1).
Endocrinologist/family medicine (3), endocrinologist/family medicine/OBGYN (4), endocrinologist/internal medicine (2), endocrinologist/internal medicine/family medicine (1), endocrinologist/internal medicine/OBGYN (4), endocrinologist/OBGYN (3), family medicine/OBGYN (5), internal medicine/family medicine (1).
Endocrinologist/family medicine (6), endocrinologist/internal medicine (7), endocrinologist/family medicine/functional medicine (1), endocrinologist/internal medicine/family medicine (1), endocrinologist/internal medicine/OBGYN (1), endocrinologist/OBGYN (1), family medicine/other (integrative medicine) (1), internal medicine/pediatrics (1), internal medicine/family medicine (1).
“ARNP with Hashimoto's herself,” “VA Hospital general practician,” “Functional Medicine doctor,” “Integrative Medicine.”
“General pract.” and “Doctor w/Biomolecular biology.”
T3, triiodothyronine; T4, thyroxine.
Ninety-one women (59.5%) reported receiving THRT counseling (Table 1). Of previously pregnant women, 75% (12/16) of those with pregnancy <1 year ago, 75% (12/16) with pregnancy 2–5 years ago, 91% (10/11) with pregnancy 6–10 years ago, and 58% (14/24) with pregnancy >10 years ago were counseled. Most (82%) were counseled by a combination of clinicians, including endocrinologists. Twenty-two women (14%) obtained information from nonclinician sources, including the internet (73%).
The proportion of women who were counseled differed by type of treating clinician (p = 0.002). A higher proportion of women treated by endocrinologists (73%) received counseling, compared with those treated by primary care physicians (33%) or obstetricians (50%). The proportion of women who were counseled differed by region (p = 0.001). Those residing in the Northeast (69%) or outside the United States (95%) received counseling more frequently compared with those residing in the Midwest (36%), West (59%), Southeast (44%), or Southwest (55%). The proportion of women receiving counseling differed by age (75% for age 18–30 years, 75% for age 31–40 years, and 38% for age 41–50 years; p < 0.001), but not by race/ethnicity.
LT4 monotherapy was used by all currently pregnant women and 57 (88%) previously pregnant women during pregnancy. Four (6%) took a combination of thyroxine/triiodothyronine/desiccated thyroid, three (5%) did not know what they took, and one was not treated during pregnancy. THRT doses were adjusted during pregnancy in 15 (88%) currently pregnant and 46 (71%) previously pregnant women (accounting for three nonresponders per group), with the majority reporting a dose increase (all currently pregnant and 85% of previously pregnant women with dose change). LT4 monotherapy use in pregnancy did not differ by types of treating clinician (p = 0.51), region (p = 0.59), age (p = 0.56), race/ethnicity (p = 0.35), or information obtained from nonclinician sources (p = 0.05).
First-trimester thyroid function was measured in 16 (94%) currently pregnant women and 43 (66%) previously pregnant women. Whether serum thyrotropin was checked in the first trimester did not differ by type of treating clinician (p = 0.40), age (p = 0.16), or race/ethnicity (p = 0.07), but it differed regionally (p = 0.013).
Our findings indicate that most currently and previously pregnant women received THRT counseling consistent with current ATA guidelines (4). However, only 25 (37%) of never-pregnant women reported receiving counseling, which may indicate a gap in care. While the ATA guidelines provide specific recommendations for screening and treatment, there is little emphasis on communication of these guidelines to patients and few studies have addressed this to date.
A 2010 U.S. study reported limited exposure of obstetric providers to the Endocrine Society guidelines (7). About 31% of women in our study reported that their hypothyroidism was managed by nonendocrine providers, who may follow different guidelines. Interestingly, 14% of women in the study reported obtaining information regarding THRT in pregnancy from nonclinician sources, especially the internet. Therefore, clinicians could recommend reliable online resources as a part of counseling to empower patients to be active participants in their own health care. The patient portals of the ATA (
Our study's major strength is its assessment of the patient perspective on gestational hypothyroidism care across geographic regions. However, there are several limitations. First, we primarily recruited women through the Friends of the ATA mailing list, a potentially more engaged population, which may have induced selection bias. Inclusion of women up to 50 years of age may have resulted in recall bias. This is perhaps indicated by the lower likelihood of receiving counseling in older women or those with pregnancy >10 years ago, although it may also indicate a change in practice pattern. The sample size was small, and a small number of participants were from outside the United States, where professional guidelines and routine clinical practice may differ. Most women identified as White, thus results may not be generalizable to other races. Future pregnancy plans were not assessed for never-pregnant women, which may confound the relative lack of counseling reported by this group.
In conclusion, most currently or previously pregnant women with hypothyroidism in our study reported receiving counseling on THRT in pregnancy. Most had thyroid function tests checked during early pregnancy and were treated with LT4 monotherapy in accordance with current ATA and American College of Obstetricians and Gynecologists (ACOG) guidelines (4,9). However, this study highlights potential gaps in preconception counseling for women of reproductive age with hypothyroidism, use of inappropriate types of THRT in pregnancy, and possible geographic variations in patient education. Large-scale patient-centered research addressing the limitations of this study are needed to better identify other potential gaps in care.
Footnotes
Authors' Contributions
The authors confirm contribution to the article as follows: study conception and design by A.L.S., A.P.F., and E.N.P.; data collection by A.L.S.; analysis and interpretation of results by A.L.S., S.Y.L., and E.N.P.; draft article preparation by A.L.S., S.Y.L., A.P.F., and E.N.P. All authors reviewed the results and approved the final version of the article.
Acknowledgments
We thank the American Thyroid Association and Friends of American Thyroid Association for allowing us to distribute the survey.
Author Disclosure Statement
No competing financial interests exist.
Funding Information
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article. This study was supported in part by the unrestricted educational grant from Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC for Anticoagulation Forum/Ansell Fellowship at Boston Medical Center (A.L.S.) and NIH K23ES028736 and Boston University School of Medicine Department of Medicine Career Investment award (S.Y.L.).