Publications by authors named "Naykky M Singh Ospina"

19 Publications

  • Page 1 of 1

Are American follow-up recommendations in endocrinology actionable? A systematic review of clinical practice guidelines.

Endocrine 2021 Jan 21. Epub 2021 Jan 21.

Endocrinology Division, Department of Internal Medicine, University Hospital "Dr. José E. González", Universidad Autonoma de Nuevo Leon, Monterrey, Mexico.

Purpose: Clinical guidelines include recommendations to guide patient's longitudinal care. These recommendations may differ in content and quality of supporting evidence from those guiding diagnosis and treatment. We aimed to identify recommendations guiding the follow-up of patients with endocrine conditions, describe their content and quality of evidence.

Methods: We systematically assessed the Endocrine Society and the American Thyroid Association clinical guidelines and identified recommendations guiding follow-up strategies to evaluate direction, content, strength, and quality of evidence.

Results: Out of 1540 recommendations, 138(8.9%) guided follow-up strategies. From these, 109 (79%) recommendations included goal of follow-up, 121(97.7%) suggested follow-up methods, and 56 (40.6%) a specific monitoring frequency. A total of 76 (55.1%) assessed treatment response, 65 (47.1%) disease progression, and 30 (21.7%) side effects. A total of 90 (65.2%) described the use of laboratory studies, 30 (21.7%) clinical exam/history, and 27 (19.6%) imaging studies. Finally, 91 (65.9%) suggested a monitoring time interval and 42 (30.4%) directed an action based on results. Most recommendations [88 (55.3%)] were based on low/very low-quality evidence. A total of 73 (52.9%) recommendations were labeled as strong, from which 12% were based on high-quality evidence.

Conclusions: One out of ten clinical recommendations for endocrine conditions guide follow-up and their content is variable. More than half of the follow-up recommendations are supported by low/very low-quality evidence and the majority does not provide an action threshold. A specific framework for developing follow-up recommendations can aid guideline panelists and support evidence-based monitoring.
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http://dx.doi.org/10.1007/s12020-020-02592-yDOI Listing
January 2021

Knowledge, Attitudes, Beliefs, and Treatment Burden Related to the Use of Levothyroxine in Hypothyroid Pregnant Women in the United States.

Thyroid 2021 04 19;31(4):669-677. Epub 2021 Jan 19.

Division of Endocrinology and Metabolism, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.

The use of prescribed medications during pregnancy is a challenge and an underestimated source of treatment burden. Levothyroxine (LT4) for the treatment of overt and subclinical hypothyroidism is extensively prescribed during pregnancy. To this end, we aimed to explore the patients' perceived benefits and risks, knowledge, beliefs, attitudes, and related burden of LT4 therapy during pregnancy. In this cross-sectional study, we surveyed pregnant women who were treated with LT4 during pregnancy from January 1, 2019, to December 31, 2019, in a tertiary academic medical center of the United States. The anonymous online survey included questions to gather demographic data and multiple-choice questions regarding the benefits and risks, knowledge, beliefs, attitudes, and burden related to LT4 use during pregnancy. Sixty-four pregnant women (mean age 31.5 years) completed the study survey (response rate: 96%): 62% were diagnosed with hypothyroidism more than 12 months before pregnancy, 16% less than or about 12 months before pregnancy, and 22% during pregnancy. We found that one-third of pregnant women using LT4 had a feeling of uneasiness/anxiety due to their hypothyroidism diagnosis. About half of the respondents (45%) reported that they did not receive an explanation by their clinician regarding the maternal/fetal risks of uncontrolled hypothyroidism or the benefits of adequate control. Finally, two in three patients expressed various concerns of LT4-related treatment burden. Our findings support the need for increased effective communication and tailored counseling to address fears, anxiety, and uncertainties about the benefits and risks of LT4 use in pregnancy. For patients with clear benefits from LT4 treatment in pregnancy, it could help to overcome their concerns, promote adherence, and decrease adverse maternal/fetal outcomes. For patients with no clear benefits established, clinicians need to be aware of LT4-related treatment burden in pregnancy and implement patient-centered approaches in their clinical practices.
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http://dx.doi.org/10.1089/thy.2020.0629DOI Listing
April 2021

Clinical Outcomes After Discontinuation of Thyroid Hormone Replacement: A Systematic Review and Meta-Analysis.

Thyroid 2021 May 29;31(5):740-751. Epub 2020 Dec 29.

Division of Endocrinology and Metabolism, Department of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.

Levothyroxine (LT4) is one of the most commonly prescribed medications. Although considered a life-long replacement therapy, LT4 therapy can be discontinued for some patients. This study aims at: (i) reviewing the evidence on clinical outcomes of patients undergoing thyroid hormone replacement discontinuation, (ii) identifying the predictors of successful discontinuation, and (iii) systematically appraising frameworks used for deprescribing thyroid hormone. We searched multiple bibliographic databases, including Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus, from inception to February 2020 for studies in which thyroid hormone replacement was discontinued. Clinical outcomes assessed included: proportion of patients that remained euthyroid or needed to restart thyroid hormone replacement after discontinuation and frequency of clinical symptoms of hypothyroidism and adverse effects. We also evaluated predictors for discontinuation and deprescribing frameworks. Reviewers (F.J.K.T., N.B., N.M.S.O., S.M.) evaluated studies for inclusion, extracted data, and assessed methodological quality independently and in duplicate. Seventeen observational studies at moderate to high risk of bias met inclusion criteria, including a total of 1103 patients (86% women) with an age range of 2-81 years. Approximately a third of patients undergoing thyroid hormone discontinuation remained euthyroid at follow-up (37.2%, 95% confidence interval [CI 24.2-50.1%], I 97.5%). Subgroup analysis showed that patients with a previous diagnosis of overt hypothyroidism (OH) were less likely to remain euthyroid (11.8% [CI 0.4-23.2%], I 90.3%) than patients with a prior diagnosis of subclinical hypothyroidism (SCH) (35.6% [CI 8.2-62.9%], I 94.0%). No study followed a framework for systematically deprescribing LT4. Low-quality evidence suggests that up to a third of patients remained euthyroid after thyroid hormone discontinuation, with a higher proportion of patients with an initial diagnosis of SCH remaining euthyroid than patients with an initial diagnosis of OH. A deprescribing framework focusing on adequate selection of patients for deprescribing LT4 and a systematic process is warranted to guide clinicians in re-evaluating the need for LT4 in their patients.
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http://dx.doi.org/10.1089/thy.2020.0679DOI Listing
May 2021

A deeper analysis in thyroid research: A meta-epidemiological study of the American Thyroid Association clinical guidelines.

PLoS One 2020 10;15(6):e0234297. Epub 2020 Jun 10.

Endocrinology Division, Department of Internal Medicine, University Hospital "Dr. José E. González", Universidad Autónoma de Nuevo León, Monterrey, México.

Background: The American Thyroid Association (ATA) uses the GRADE or the American College of Physicians (ACP) system to develop recommendations. Recommendations based on low-quality evidence should spur for the conduction of clinical studies, if feasible. The extent to which recommendations by the ATA based on low-quality of evidence are being actively researched remains unknown.

Methods: Clinical guidelines produced by the ATA using the GRADE or the ACP system to classify evidence were deemed eligible. Reviewers, in duplicate and independently, extracted therapeutic recommendations based on low-quality evidence, whereas recommendations with higher quality of evidence, aimed at diagnosis, or best practice statements were excluded. Eligible recommendations based on low-quality evidence were deconstructed to their components using the PICO format. We then searched on clinicaltrials.gov to identify ongoing research. Trials were deemed eligible if they addressed the PICO question with at least one of the intended outcomes.

Results: A total of 543 recommendations were retrieved, of which 305 (56%) were based on low-quality of evidence and only 90 were deemed eligible. Of these, we found that 33 (37%) recommendations were actively being researched in 53 clinical trials. Most of the trials were randomized and funded by non-profit organizations. Many clinical trials studied thyroid nodules and differentiated thyroid cancer (26/53; 49%), whereas few studied were aimed at anaplastic thyroid cancer (2/53; 4%).

Conclusion: One out of three of gaps in evidence, identified as low quality during the development of ATA guidelines, are currently actively researched. This finding calls for the need to develop a better research infrastructure and funding to support thyroid research.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0234297PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7286515PMC
August 2020

Patient Experiences and Perceptions Associated with the Use of Desiccated Thyroid Extract.

Medicina (Kaunas) 2020 Apr 3;56(4). Epub 2020 Apr 3.

Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN 55902, USA.

It is unclear why many patients with hypothyroidism prefer the use of desiccated thyroid extract (DTE) as a thyroid hormone replacement formulation over levothyroxine (LT4) treatment, as recommended by clinical practice guidelines. We analyzed patient-reported information from patient online forums to better understand patient preferences for and attitudes toward the use of DTE to treat hypothyroidism. We conducted a mixed-methods study by evaluating the content of online posts from three popular hypothyroidism forums from patients currently taking DTE ( = 673). From these posts, we extracted descriptive information on patient demographics and clinical characteristics and qualitatively analyzed posts' content to explore patient perceptions on DTE and other therapies further. Nearly half (46%) of the patients reported that a clinician initially drove their interest in trying DTE. Patients described many reasons for switching from a previous therapeutic approach to DTE, including lack of improvement in hypothyroidism-related symptoms (58%) and the development of side effects (22%). The majority of patients described DTE as moderately to majorly effective overall (81%) and more effective than the previous therapy (77%). The most frequently described benefits associated with DTE use were an improvement in symptoms (56%) and a change in overall well-being (34%). One-fifth of patients described side effects related to the use of DTE. Qualitative analysis of posts' content supported these findings and raised additional issues around the need for individualizing therapy approaches for hypothyroidism (e.g., a sense of each patient has different needs), as well as difficulties obtaining DTE (e.g., issues with pharmacy availability). Lack of individualized treatment and a feeling of not been listened to were recurrent themes among DTE users. A subset of patients may prefer DTE to LT4 for many reasons, including perceived better effectiveness and improved overall well-being, despite the risks associated with DTE.
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http://dx.doi.org/10.3390/medicina56040161DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7230696PMC
April 2020

Pituitary adenomas in the setting of multiple endocrine neoplasia type 1: a single-institution experience.

J Neurosurg 2020 Apr 3:1-7. Epub 2020 Apr 3.

Departments of1Neurological Surgery.

Objective: Multiple endocrine neoplasia type 1 (MEN1) is a rare, autosomal-dominant tumor disorder characterized by the development of pituitary tumors and other endocrine neoplasms. Diagnosis is made clinically based on the development of 2 or more canonical lesions (parathyroid gland, anterior pituitary, and enteropancreatic tumors) or in family members of a patient with a clinical diagnosis of MEN1 and the occurrence of one of the MEN1-associated tumors. The goal of this study was to characterize pituitary tumors arising in the setting of MEN1 at a single institution. The probability of tumor progression and the likelihood of surgical intervention in patients with asymptomatic nonfunctional pituitary adenomas were also analyzed.

Methods: A retrospective review of a prospectively maintained institutional database was performed for patients with MEN1 diagnosed from 1970 to 2017. Data included patient demographics, tumor characteristics, treatment strategies, and outcomes.

Results: A review of the database identified 268 patients diagnosed with MEN1, of whom 158 (59%) were female. Among the 268 patients, 139 (51.8%) had pituitary adenomas. There was a higher prevalence in women than in men (65% vs 35%, p < 0.005). Functional adenomas (57%) were more common. Prolactin-secreting adenomas were the most common functional tumors. Macroadenomas were seen in 27% of patients and were more likely to be symptomatic and locally aggressive (p < 0.001). Forty-nine patients (35%) underwent transsphenoidal resection at some point during their disease course. In 52 patients who were initially observed with MEN1 asymptomatic nonfunctional adenomas, only 5 (10%) progressed to need surgery. In MEN1 patients, an initial parathyroid lesion is most likely followed in order by pituitary, pancreatic, adrenal, and, finally, rare carcinoid tumors.

Conclusions: Asymptomatic nonfunctional pituitary adenomas in patients with MEN1 may be followed safely with MRI. In this series, parathyroid tumors developed at the lowest median age of all cardinal tumors, and development of additional cardinal MEN1 lesions followed a predictable pattern. This pattern of disease progression could have significant implications for disease surveillance in clinical practice and may help to target clinical resources to the lesions most likely to develop next. This may aid with early detection and treatment and warrants further study.
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http://dx.doi.org/10.3171/2020.1.JNS193538DOI Listing
April 2020

Documentation of hypoglycemia assessment among adults with diabetes during clinical encounters in primary care and endocrinology practices.

Endocrine 2020 03 4;67(3):552-560. Epub 2019 Dec 4.

Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.

Purpose: To examine the proportion of diabetes-focused clinical encounters in primary care and endocrinology practices where the evaluation for hypoglycemia is documented; and when it is, identify clinicians' stated actions in response to patient-reported events.

Methods: A total of 470 diabetes-focused encounters among 283 patients nonpregnant adults (≥18 years) with type 1 or type 2 diabetes mellitus in this retrospective cohort study. Participants were randomly identified in blocks of treatment strategy and care location (95 and 52 primary care encounters among hypoglycemia-prone medications (i.e. insulin, sulfonylurea) and others patients, respectively; 94 and 42 endocrinology encounters among hypo-treated and others, respectively). Documentation of hypoglycemia and subsequent management plan in the electronic health record were evaluated.

Results: Overall, 132 (46.6%) patients had documentation of hypoglycemia assessment, significantly more prevalent among hypo-treated patients seen in endocrinology than in primary care (72.3% vs. 47.4%; P = 0.001). Hypoglycemia was identified by patient in 38.2% of encounters. Odds of hypoglycemia assessment documentation was highest among the hypo-treated (OR 13.6; 95% CI 5.5-33.74, vs. others) and patients seen in endocrine clinic (OR 4.48; 95% CI 2.3-8.6, vs. primary care). After documentation of hypoglycemia, treatment was modified in 30% primary care and 46% endocrine clinic encounters; P = 0.31. Few patients were referred to diabetes self-management education and support (DSMES).

Conclusions: Continued efforts to improve hypoglycemia evaluation, documentation, and management are needed, particularly in primary care. This includes not only screening at-risk patients for hypoglycemia, but also modifying their treatment regimens and/or leveraging DSMES.
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http://dx.doi.org/10.1007/s12020-019-02147-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7192242PMC
March 2020

Practice Variation in the Care of Subclinical Hypothyroidism During Pregnancy: A National Survey of Physicians in the United States.

J Endocr Soc 2019 Oct 1;3(10):1892-1906. Epub 2019 Aug 1.

Division of Endocrinology and Metabolism, Center for Osteoporosis and Metabolic Bone Diseases, University of Arkansas for Medical Sciences, Little Rock, Arkansas.

Evidence regarding the effects of subclinical hypothyroidism (SCH) on adverse pregnancy outcomes and the ability of levothyroxine (LT4) treatment to prevent them is unclear. Available recommendations for the management of SCH during pregnancy are inconsistent. We conducted a nationwide survey among physicians assessing their knowledge of and current practices in the care of SCH in pregnancy and compared these with the most recent American Thyroid Association (ATA) recommendations. In this cross-sectional study, an online survey was sent to active US members of the Endocrine Society. This survey included questions about current practices and clinical scenarios aimed at assessing diagnostic evaluation, initiation of therapy, and follow-up in pregnant women with SCH. In total, 162 physicians completed the survey. ATA guidelines were reviewed by 76%, of whom 53% indicated that these guidelines actually changed their practice. Universal screening was the preferred screening approach (54%), followed by targeted screening (30%). For SCH diagnosis, most respondents (52%) endorsed a TSH level >2.5 mIU/L as a cutoff, whereas 5% endorsed a population-based cutoff as recommended by the ATA. The decision to initiate treatment varied depending on the specific clinical scenario; however, when LT4 was initiated, respondents expected a small/very small reduction in maternofetal complications. In conclusion, despite recently updated guidelines, there is still wide variation in clinical practices regarding the care of women with SCH in pregnancy. Highly reliable randomized trials are required to evaluate the effectiveness of the most uncertain treatment practices on the care of pregnant women with SCH.
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http://dx.doi.org/10.1210/js.2019-00196DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6777401PMC
October 2019

Variation in treatment practices for subclinical hypothyroidism in pregnancy: US national assessment.

J Clin Endocrinol Metab 2019 Apr 24. Epub 2019 Apr 24.

Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.

Context: Although thyroid hormone replacement may improve outcomes in pregnant women with subclinical hypothyroidism (SCH), the extent to which they receive treatment is unknown.

Objective: To describe levothyroxine (LT4) treatment practices for pregnant women with SCH.

Design: Retrospective cohort study.

Setting: Large U.S. administrative claims database.

Participants: Pregnant women with SCH defined by untreated TSH 2.5-10 mIU/L.

Main Outcome Measure: Initiation of LT4 as a function of treating clinician specialty (endocrinology, obstetrics/gynecology, primary care, or other), baseline TSH, patient clinical and demographic factors, and U.S. region.

Results: We identified 7,990 pregnant women with SCH; only 1,214 (15.2%) received LT4. Treatment was significantly more likely in patients with higher TSH, obesity, recurrent pregnancy loss, thyroid disease, and cared by endocrinologists. Proportion of treated women increased over time; LT4 treatment was twice as likely in 2014 as in 2010. Women in Northeast and West U.S. were significantly more likely to receive LT4 compared to other regions. Asian women were more likely, while Hispanic women were less likely, to receive LT4 compared to White women. Endocrinologists started LT4 at lower TSH thresholds than other specialties, and treated women who were more likely to have had recurrent pregnancy loss and thyroid disease than women treated by other clinicians.

Conclusions: We found large variation in the prescription of LT4 to pregnant women with SCH, though most treatment-eligible women remained untreated. Therapy initiation is associated with geographic, clinician, and patient characteristics. This evidence can inform quality improvement efforts to optimize care for pregnant women with SCH.
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http://dx.doi.org/10.1210/jc.2019-00057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6667278PMC
April 2019

Ethanol Ablation for the Treatment of Cystic and Predominantly Cystic Thyroid Nodules.

Mayo Clin Proc 2018 08 4;93(8):1009-1017. Epub 2018 Jul 4.

Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN. Electronic address:

Objective: To determine the efficacy and safety of percutaneous ethanol injection (PEI) for the treatment of symptomatic cystic thyroid nodules.

Patients And Methods: Retrospective analysis of patients with benign cystic thyroid nodules treated with PEI from February 1, 2000, through October 31, 2016. The main outcomes were efficacy, defined as symptom relief or reduction in nodule volume of 50% or more, and safety, defined as no or minor adverse events.

Results: Twenty patients had PEI. Mean age at the time of PEI was 50 years, and 13 (65%) were women; all patients were euthyroid. Twelve patients (60%) had complex cystic thyroid nodules (>50% cystic component), with the rest being purely cystic. The median largest diameter of the thyroid cyst was 4.5 cm (interquartile range [IQR], 3.2-5.3 cm; range, 2.3-8.0 cm); the median volume pre-PEI was 19.6 mL (IQR, 10.4-48.5 mL; range, 2.8-118.1 mL). The median amount of cystic fluid drained before PEI was 13.5 mL (IQR, 6.8-32.3 mL), and the median amount of ethanol administered was 3 mL (IQR, 2-5 mL; range, 0.5-20 mL). After median follow-up of 2 years, 17 of 19 patients (89%) were asymptomatic. Of 10 patients with available imaging on follow-up, 7 (70%) had a 50% or greater reduction in nodule volume (median volume decrease, 75.64% [IQR, 41.40%-91.99%]). Adverse effects occurred in 4 patients (20%) and were mild and temporary (slight pain, vagal reaction, and bleeding into the cyst).

Conclusion: Percutaneous ethanol injection seems to be a safe and effective alternative to surgical resection for patients with purely or predominantly cystic thyroid nodules and compressive symptoms who decline surgery or are not good surgical candidates.
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http://dx.doi.org/10.1016/j.mayocp.2018.05.020DOI Listing
August 2018

Subclinical Hypothyroidism in Women Planning Conception and During Pregnancy: Who Should Be Treated and How?

J Endocr Soc 2018 Jun 3;2(6):533-546. Epub 2018 May 3.

Division of Endocrinology, Department of Medicine, National University of Ireland, Galway, Ireland.

Subclinical hypothyroidism (SCH), a mild form of hypothyroidism defined as elevated TSH with normal free thyroxine levels, is a common diagnosis among women of reproductive age. In some, but not all, studies, it has been associated with infertility, an increased risk of adverse pregnancy and neonatal outcomes, and possibly with an increased risk of neurocognitive deficits in offspring. Despite well-established recommendations on treatment of overt hypothyroid pregnant women, a consensus has not yet been reached on whether to treat women with SCH. This review focuses on examining the evidence informing the clinical strategy for using levothyroxine (LT4) in women with SCH during pregnancy and those who are planning conception. A crucial first step is to accurately diagnose SCH using the appropriate population-based reference range. For pregnant women, if this is unavailable, the recommended TSH upper normal limit cutoff is 4.0 mIU/L. There is evidence supporting a decreased risk for pregnancy loss and preterm delivery for pregnant women with TSH > 4.0 mIU/L receiving LT4 therapy. LT4 treatment has been associated with better reproductive outcomes in women with SCH undergoing artificial reproductive techniques, but not in those who are attempting natural conception. Thyroid function tests need to be repeated throughout pregnancy to monitor LT4 therapy. In addition to potential harms, LT4 contributes to treatment burden. During a consultation, clinicians and patients should engage in a careful consideration of the current evidence in the context of the patients' values and preferences to determine whether LT4 therapy initiation is the best next step.
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http://dx.doi.org/10.1210/js.2018-00090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5961023PMC
June 2018

Thyroid hormone treatment among pregnant women with subclinical hypothyroidism: US national assessment.

BMJ 2017 Jan 25;356:i6865. Epub 2017 Jan 25.

Knowledge and Evaluation Research Unit in Endocrinology (KER_Endo), Mayo Clinic, Rochester, MN 55905, USA.

Objective:  To estimate the effectiveness and safety of thyroid hormone treatment among pregnant women with subclinical hypothyroidism.

Design:  Retrospective cohort study.

Setting:  Large US administrative database between 1 January 2010 and 31 December 2014.

Participants:  5405 pregnant women with subclinical hypothyroidism, defined as untreated thyroid stimulating hormone (TSH) concentration 2.5-10 mIU/L.

Exposure:  Thyroid hormone therapy.

Main Outcome Measure:  Pregnancy loss and other pre-specified maternal and fetal pregnancy related adverse outcomes.

Results:  Among 5405 pregnant women with subclinical hypothyroidism, 843 with a mean pre-treatment TSH concentration of 4.8 (SD 1.7) mIU/L were treated with thyroid hormone and 4562 with a mean baseline TSH concentration of 3.3 (SD 0.9) mIU/L were not treated (P<0.01). Pregnancy loss was significantly less common among treated women (n=89; 10.6%) than among untreated women (n=614; 13.5%) (P<0.01). Compared with the untreated group, treated women had lower adjusted odds of pregnancy loss (odds ratio 0.62, 95% confidence interval 0.48 to 0.82) but higher odds of preterm delivery (1.60, 1.14 to 2.24), gestational diabetes (1.37, 1.05 to 1.79), and pre-eclampsia (1.61, 1.10 to 2.37); other pregnancy related adverse outcomes were similar between the two groups. The adjusted odds of pregnancy loss were lower in treated women than in untreated women if their pre-treatment TSH concentration was 4.1-10 mIU/L (odds ratio 0.45, 0.30 to 0.65) but not if it was 2.5-4.0 mIU/L (0.91, 0.65 to 1.23) (P<0.01).

Conclusion:  Thyroid hormone treatment was associated with decreased risk of pregnancy loss among women with subclinical hypothyroidism, especially those with pre-treatment TSH concentrations of 4.1-10 mIU/L. However, the increased risk of other pregnancy related adverse outcomes calls for additional studies evaluating the safety of thyroid hormone treatment in this patient population.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5266622PMC
http://dx.doi.org/10.1136/bmj.i6865DOI Listing
January 2017

Ramifications of New Terminology for Encapsulated Follicular Variant of Papillary Thyroid Carcinoma.

JAMA Oncol 2016 08;2(8):1097

Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Medicine, Mayo Clinic, Rochester, Minnesota.

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http://dx.doi.org/10.1001/jamaoncol.2016.2208DOI Listing
August 2016

Effects of increasing levothyroxine on pregnancy outcomes in women with uncontrolled hypothyroidism.

Clin Endocrinol (Oxf) 2017 Jan 23;86(1):150-155. Epub 2016 Aug 23.

Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA.

Objective: Uncontrolled hypothyroidism has been associated with an increased risk of adverse pregnancy outcomes. We aimed to assess the effectiveness of increasing levothyroxine (LT4) dose on reducing the risk of adverse outcomes for pregnant women with TSH level greater than the recommended 1st trimester limit.

Design, Patients, Measurements: We reviewed the electronic medical records of pregnant women evaluated from January 2011 to December 2013, who had history of LT4-treated hypothyroidism and were found to have TSH > 2·5 mIU/l in 1st trimester. Women were divided into two groups: group A - LT4 dose was increased within two weeks from the TSH test, group B - LT4 dose remained stable. We compared the frequency of pregnancy loss (primary outcome) and other prespecified pregnancy-related adverse outcomes between groups.

Results: There were 85 women in group A (median TSH: 5·0, interquartile range 3·8-6·8 mIU/l) and 11 women in group B (median TSH: 4·5, interquartile range 3·2-4·9 mIU/l). The groups were not different in baseline clinical and socioeconomic characteristics. The mean interval between TSH test and LT4 dose increase was 4·5 (SD 4·6) days. Pregnancy loss was significantly lower in group A (2/85, 2·4%) vs group B (4/11, 36·4%) (P = 0·001). Other pregnancy-related adverse outcomes were similar between groups.

Conclusions: Increasing LT4 dose for women with uncontrolled hypothyroidism in the 1st trimester of pregnancy was associated with a decreased risk of pregnancy loss. Given the limitations of our study, this association awaits further confirmation from larger studies.
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http://dx.doi.org/10.1111/cen.13168DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5161643PMC
January 2017

Effects of Levothyroxine Therapy on Pregnancy Outcomes in Women with Subclinical Hypothyroidism.

Thyroid 2016 07 16;26(7):980-6. Epub 2016 May 16.

1 Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic , Rochester, Minnesota.

Background: Subclinical hypothyroidism (SCH) has been associated with increased risk of adverse pregnancy outcomes in some, but not all, studies. Uncertainty remains regarding the impact of levothyroxine (LT4) therapy on improving health outcomes in pregnant women with SCH. The objective of this study was to assess the potential benefits of LT4 therapy in pregnant women with SCH.

Methods: The medical records were reviewed of pregnant women with SCH, defined as an elevated serum thyrotropin (TSH) of >2.5 mIU/L for the 1st trimester or >3 mIU/L for the 2nd and 3rd trimesters, but ≤10 mIU/L. Pregnant women were divided into two groups depending on whether they received LT4 (group A) or not (group B). Pregnancy loss and other pre-specified adverse outcomes were evaluated during follow-up.

Results: There were 82 women in group A and 284 in group B. Group A had a higher body mass index (p = 0.04) and a higher serum TSH level (p < 0.0001) compared with group B. Group A had fewer pregnancies lost (n = 5 [6.1%] vs. n = 25 [8.8%]; p = 0.12), low birth weight (LBW) offspring (1.3% vs. 10%; p < 0.001), and no neonates with a five-minute Apgar score ≤7 (0% vs. 7%; p < 0.001) compared with group B. Other pregnancy-related adverse outcomes were similar between the two groups. Inferences remained unchanged after considering different models to adjust for potential predictors of outcome.

Conclusions: LT4 therapy is associated with a decreased risk of LBW and a low Apgar score among women with SCH. This association awaits confirmation in randomized trials before the widespread use of LT4 therapy in pregnant women with SCH.
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http://dx.doi.org/10.1089/thy.2016.0014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4939379PMC
July 2016

Outcomes of Parathyroidectomy in Patients with Primary Hyperparathyroidism: A Systematic Review and Meta-analysis.

World J Surg 2016 Oct;40(10):2359-77

Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.

Background: Parathyroidectomy is a definitive treatment for primary hyperparathyroidism. Patients contemplating this intervention will benefit from knowledge regarding the expected outcomes and potential risks of the currently available surgical options.

Purpose: To appraise and summarize the available evidence regarding benefits and harms of minimally invasive parathyroidectomy (MIP) and bilateral neck exploration (BNE).

Data Sources: A comprehensive search of multiple databases (MEDLINE, EMBASE, and Scopus) from each database's inception to September 2014 was performed.

Study Selection: Eligible studies evaluated patients with primary hyperparathyroidism undergoing MIP or BNE.

Data Extraction: Reviewers working independently and in duplicate extracted data and assessed the risk of bias.

Data Synthesis: We identified 82 observational studies and 6 randomized trials at moderate risk of bias. Most of them reported outcomes after MIP (n = 71). Using random-effects models to pool results across studies, the cure rate was 98 % (95 % CI 97-98 %, I (2) = 10 %) with BNE and 97 % (95 % CI 96-98 %, I (2) = 86 %) with MIP. Hypocalcemia occurred in 14 % (95 % CI 10-17 % I (2) = 93 %) of the BNE cases and in 2.3 % (95 % CI 1.6-3.1 %, I (2) = 87 %) with MIP (P < 0.001). There was a statistically significant lower risk of laryngeal nerve injury with MIP (0.3 %) than with BNE (0.9 %), but similar risk of infection (0.5 vs. 0.5 %) and mortality (0.1 vs. 0.5 %).

Limitations: The available evidence, mostly observational, is at moderate risk of bias, and limited by indirect comparisons and inconsistency for some outcomes (cure rate, hypocalcemia).

Conclusion: MIP and BNE are both effective surgical techniques for the treatment of primary hyperparathyroidism. The safety profile of MIP appears superior to BNE (lower rate of hypocalcemia and recurrent laryngeal nerve injury).
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http://dx.doi.org/10.1007/s00268-016-3514-1DOI Listing
October 2016

Subclinical Hypothyroidism in Pregnancy: A Systematic Review and Meta-Analysis.

Thyroid 2016 Apr 3;26(4):580-90. Epub 2016 Mar 3.

1 Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic , Rochester, Minnesota.

Background: The impact of subclinical hypothyroidism (SCH) and of levothyroxine replacement in pregnant women with SCH is unclear. The aims of this study were to assess (i) the impact of SCH during pregnancy on maternal and neonatal outcomes, and (ii) the effect of levothyroxine replacement therapy in these patients.

Methods: Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE, the Cochrane Controlled Trials Register, Ovid EMBASE, Web of Science, and Scopus were searched from inception to January 2015. Randomized trials and cohort studies of pregnant women with SCH that examined adverse pregnancy and neonatal outcomes were included. Reviewers extracted data and assessed methodological quality in duplicate. Eighteen cohort studies at low-to-moderate risk of bias were included. Compared with euthyroid pregnant women, pregnant women with SCH were at higher risk for pregnancy loss (relative risk [RR] 2.01 [confidence interval (CI) 1.66-2.44]), placental abruption (RR 2.14 [CI 1.23-3.70]), premature rupture of membranes (RR 1.43 [CI 1.04-1.95]), and neonatal death (RR 2.58 [CI 1.41-4.73]). One study at high risk of bias compared pregnant women with SCH who received levothyroxine to those who did not and found no significant decrease in the rate of pregnancy loss, preterm delivery, gestational hypertension, low birth weight, or low Apgar score.

Conclusions: SCH during pregnancy is associated with multiple adverse maternal and neonatal outcomes. The value of levothyroxine therapy in preventing these adverse outcomes remains uncertain.
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http://dx.doi.org/10.1089/thy.2015.0418DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4827301PMC
April 2016

PREDICTORS OF BIOCHEMICAL REMISSION AND RECURRENCE AFTER SURGICAL AND RADIATION TREATMENTS OF CUSHING DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS.

Endocr Pract 2016 04 20;22(4):466-75. Epub 2016 Jan 20.

Objective: We conducted a systematic review and meta-analysis to synthesize the evidence about predictors that may affect biochemical remission and recurrence after transsphenoidal surgery (TSS), radiosurgery (RS), and radiotherapy (RT) in Cushing disease.

Methods: We searched multiple databases through December 2014 including original controlled and uncontrolled studies that enrolled patients with Cushing disease who received TSS (first-line), RS, or RT. We extracted data independently, in duplicates. Outcomes of interest were biochemical remission and recurrence. A meta-analysis was conducted using the random-effects model to estimate event rates with 95% confidence intervals (CIs).

Results: First-line TSS was associated with high remission (76% [95% CI, 72 to 79%]) and low recurrence rates (10% [95% CI, 6 to 16%]). Remission after TSS was higher in patients with microadenomas or positive-adrenocorticotropic hormone tumor histology. RT was associated with a high remission rate (RS, 68% [95% CI, 61 to 77%]; RT, 66% [95% CI, 58 to 75%]) but also with a high recurrence rate (RS, 32% [95% CI, 16 to 60%]; RT, 26% [95% CI, 14 to 48%]). Remission after RS was higher at short-term follow-up (≤2 years) and with high-dose radiation, while recurrence was higher in women and with lower-dose radiation. Remission was after RT in adults who received TSS prior to RT, and with lower radiation doses. There was heterogeneity (nonstandardization) in the criteria and cutoff points used to define biochemical remission and recurrence.

Conclusion: First-line TSS is associated with high remission and low recurrence, while RS and RT are associated with reasonable remission rates but important recurrence rates. The current evidence warrants low confidence due to the noncomparative nature of the studies, high heterogeneity, and imprecision.
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http://dx.doi.org/10.4158/EP15922.RADOI Listing
April 2016