Medication adherence among pregnant women with hypothyroidism—missed opportunities to improve reproductive health? A cross-sectional, web-based study
Introduction
Hypothyroidism prevalence rates in pregnancy are described to be around 2–3% [1] with clinical hypothyroidism rates between 0.3–0.5%. However, substantially higher rates of up to 24% for increased thyrotropin (TSH) levels [2], and up to 2% for clinical hypothyroidism [3] have also been observed in some areas. Prevalence increases with age, therefore the trend towards delaying childbearing has been contributing to prevalence increase in pregnancy [4]. Since untreated hypothyroidism is known to be associated with various severe pregnancy complications such as miscarriage, preterm birth, gestational hypertension [5], placental abruption [6] and even with potential adverse foetal outcomes [7], adherence to the prescribed hypothyroidism treatment is essential for reproductive health. Clinical guidelines recommend a monthly control of TSH for pregnant women on levothyroxine in the first half of their pregnancy, because levothyroxine-dose adjustment (i.e. an up to 50% increase of the dose) is sometimes required [8].
Noteworthy, levothyroxine treatment or iodine supplementation in pregnancy are safe and health benefits can be expected for both the pregnant woman and her foetus. Despite this fact, little is known about medication use and adherence in women with hypothyroidism in pregnancy so far.
While drug intake in pregnancy is common, many women are still sceptical about drugs in pregnancy. Overestimation of teratogenic risks and avoiding any medication as soon as pregnancy is recognized are observed [9], [10], [11]. Previous studies have shown that women’s beliefs about medication and perception of medication related teratogenic risk are substantially influencing drug adherence in pregnancy [12], [13]. None of these studies, however, included the perceptions of risks related to hypothyroidism treatment.
Personality has also been related to health behaviour [14], [15]. Conscientiousness (i.e. control of impulse and self-constraint) and neuroticism (i.e. propensity to feel anxious, nervous, sad, and tense) were the most important personality traits related to drug adherence [16], [17], [18]. Whether this also applies to hypothyroidism treatment in pregnancy is unknown.
Despite its undeniable importance for maternal and foetal health, the degree of adherence to hypothyroidism treatment in pregnancy and the risk factors for low adherence still remain to be elucidated. We have utilized a data set from a multinational, web-based study on medication use in pregnancy to characterize women medicating and not medicating their hypothyroidism during pregnancy. Additionally, factors associated with low adherence by exploring pregnant women’s socio-demographic, life style and medical characteristics as well as their beliefs about medication and their personality traits have been analysed. A better understanding of these influences could improve counselling to pregnant women with hypothyroidism and help them overcome adherence obstacles.
Section snippets
Study design and data collection
This multinational, cross-sectional, web-based study was simultaneously performed in 18 countries in Western, Northern and Eastern Europe, North America and Australia. Pregnant women at any gestational week were eligible to participate. An anonymous online questionnaire (http://www.questback.com) was used to collect data; the questionnaire [19] could be accessed for a period of two months in each participating country between 1-Oct-2011 and 29-Feb-2012 and was open to the public via websites
Population characteristics
The online questionnaire was accessed by 5166 pregnant women and of these, 5095 (98.6%) accepted and completed it. We excluded women with no eligible country of residency from the analysis, as well as women not suffering from hypothyroidism, leaving 231 (4.7%) participants. Of these, use of thyroid medication during pregnancy was reported by 215 women; two out of 215 women did not fill the MMAS-8 (<75% completion) and were excluded from the analysis, leading to a final study population of 213
Discussion
This investigation is the first to extensively explore pregnant women’s adherence to their hypothyroidism treatment, providing important information for patient counselling.
On the positive side we found that adherence to pharmacotherapy for hypothyroidism during pregnancy is relatively high. About 93% of pregnant women with hypothyroidism use their thyroid medication and among them, 83% show medium to high adherence. However, 17% of women demonstrated low adherence indicating that a clinically
Funding
The study has received financial support from the Norwegian Research Council (Grant no. 216771/F11) and the Foundation for Promotion of Norwegian Pharmacies and the Norwegian Pharmaceutical Society.
Details of ethics approval
This study was carried out in compliance with the Helsinki Declaration. Informed consent was given by the participants by ticking the answer “yes” to the question “Are you willing to participate in the study?” The Regional Ethics Committee in Norway, region southeast, approved the study. Ethical approval or study notification to the relevant national Ethics Boards was achieved in specific countries as required by national legislation. All data were handled and stored anonymously.
Contribution to authorship
HJ, AL, and HN have developed the research question, drafted the article and contributed to data acquisition and interpretation, AL has analysed the data, SV and EY have contributed to data interpretation and critically revised the article for intellectual content and provided medical (SV) and psychological (EY) expertise.
Disclosure
We have no conflict of interests to report and confirm that all patient/personal identifiers have been removed or disguised so the patient/person(s) described are not identifiable and cannot be identified through the details of the story.
Acknowledgments
We thank the Steering Committee of OTIS and ENTIS for reviewing the study protocol, all website providers who contributed to the recruitment phase, Professor DE. Morisky and Professor R. Horne for the permission to use the MMAS-8 and BMQ-Specific, respectively. We are also grateful to all the participating women who took part in this study and the national study coordinators (Spigset O, Twigg MJ, Zagorodnikova K, Mårdby AC, Moretti ME, Drozd M, Panchaud A, Hameen-Anttila K, Rieutord A, Gjergja
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