Developing a tool that could reliably refute total thyroidectomy for solitary Bethesda IV thyroid nodules.

PURPOSE: To assess the reliability of a simple, accessible, cost-effective rule-out tool, for use in triaging patients with Bethesda IV nodules to appropriate surgery. METHODS: The diagnostic tool was assembled by combining the negativity for suspicious ultrasound features (irregular margins, microcalcification, and a taller-than-wide orientation), and mutational marker negativity (BRAF and NRAS). The tool, (US-/mutation-), was tested on 167 patients with solitary Bethesda IV nodules. The primary outcome was its negative predictive value (NPV) for lesions requiring total thyroidectomy (TT). The impact of mutational marker negativity, as part of the tool, was evaluated by comparing the NPV of (US-/mutation-) to that of (US-/mutation+). RESULTS: 10 out of 167 lesions were positive for a mutational marker. These underwent TT, and only 2/10 (20%) were benign, on final histology. In 6/8 malignant lesions, TT was concordant with current clinical guidelines. 157 patients comprised the negative study cohort, for both mutational markers and suspicious US features. These underwent thyroid lobectomy, and 17 cases resulted in malignancy, only 8 of which required completion thyroidectomy. Accordingly, the NPV of (US-/mutation-) for malignancy was 89% (140/157), and 95% (149/157) for malignancy requiring TT. However, the NPV of (US-/mutation+) was 20% for malignancy, and 40% for malignancy requiring TT. These differences were statistically significant (89% vs. 20%; p < 0.0001, and 95% vs. 40%; p < 0.0001). CONCLUSION: US-/mutation- is a reliable rule-out tool, with sufficient diagnostic accuracy to spare patients, with Bethesda IV nodules, an overly radical TT.

Diagnostic Strategies for Gestational Diabetes Mellitus: Review of Current Evidence.

PURPOSE OF REVIEW: Currently, the diagnosis of gestational diabetes mellitus (GDM) lacks uniformity. Several controversies are still under debate, especially on the method of screening and diagnosis. This review focuses on recent literature and provides current evidence for the screening and diagnosis of GDM. RECENT FINDINGS: Selective screening would miss a significant number of women with GDM. In contrast, universal screening has been shown to be cost-effective, compared with selective screening, and is recommended by many medical societies. For the diagnostic methods for GDM, most observational cohort studies reported that the one-step method is associated with improved pregnancy outcomes and is cost-saving or cost-effective, compared with the two-step method, although these findings should be confirmed in the upcoming randomized controlled trials which compare the performance of one-step and two-step methods. On the other hand, the methods of early screening or diagnosis of GDM are varied, and current evidence does not justify their use during early pregnancy. In conclusion, current evidence favors universal screening for GDM using the one-step method. Early screening for GDM is not favorably supported by the literature.

[Clinical significance and cost-benefit analysis of serum calcitonin assay in diagnosis and treatment of medullary thyroid carcinoma].

Objective: To study the clinical significance of serum calcitonin in the diagnosis and treatment of medullary thyroid carcinoma and to analyze its cost-benefit. Methods: One hundred and forty one patients with medullary thyroid carcinoma who undertook calcitonin test and frozen pathological examination were enrolled in this study from Oct 2012 to Mar 2018. Using the method of χ(2) test, the positive rate of calcitonin test and frozen pathological examination in diagnosis of medullary thyroid carcinoma(MTC) were compared. Firstly, we compared the correct checkout cost of calcitonin test and that of frozen pathological examination (total number of patients×cost of examination/the correctly detected number of patients) . Secondly, we calculated whether calcitonin test help patients save money(average cost of treatment in hospital for MTC×number of patients who were evaluated to be candidate for surgery-cost of calcitonin test×total number of patients)/total number of patients. Results: 139 patients were positive in calcitonin test among 141 patients, and the positive rate was 98.58%. 91 patients were positive in frozen pathological examination, and the positive rate was 64.54% (χ(2)=97.821, P<0.000 1) . Cost-benefit analysis showed that the correct checkout cost of calcitonin test and frozen pathological examination were 71.01 yuan and 426.10 yuan, also,1 371 938.64 yuan could be saved totally and 9 730.06 yuan could be saved per patient because of calcitonin test. Conclusion: Serum calcitonin test had a significant effect on the diagnosis and treatment of medullary thyroid carcinoma and was economical and practical.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY GUIDELINES FOR MANAGEMENT OF DYSLIPIDEMIA AND PREVENTION OF CARDIOVASCULAR DISEASE - EXECUTIVE SUMMARYComplete Appendix to Guidelines available at http://journals.aace.com.

OBJECTIVE: The development of these guidelines is mandated by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPGs). METHODS: Each Recommendation is based on a diligent review of the clinical evidence with transparent incorporation of subjective factors. RESULTS: The Executive Summary of this document contains 87 Recommendations of which 45 are Grade A (51.7%), 18 are Grade B (20.7%), 15 are Grade C (17.2%), and 9 (10.3%) are Grade D. These detailed, evidence-based recommendations allow for nuance-based clinical decision making that addresses multiple aspects of real-world medical care. The evidence base presented in the subsequent Appendix provides relevant supporting information for Executive Summary Recommendations. This update contains 695 citations of which 202 (29.1 %) are evidence level (EL) 1 (strong), 137 (19.7%) are EL 2 (intermediate), 119 (17.1%) are EL 3 (weak), and 237 (34.1%) are EL 4 (no clinical evidence). CONCLUSION: This CPG is a practical tool that endocrinologists, other healthcare professionals, regulatory bodies and health-related organizations can use to reduce the risks and consequences of dyslipidemia. It provides guidance on screening, risk assessment, and treatment recommendations for a range of patients with various lipid disorders. These recommendations emphasize the importance of treating low-density lipoprotein cholesterol (LDL-C) in some individuals to lower goals than previously recommended and support the measurement of coronary artery calcium scores and inflammatory markers to help stratify risk. Special consideration is given to patients with diabetes, familial hypercholesterolemia, women, and pediatric patients with dyslipidemia. Both clinical and cost-effectiveness data are provided to support treatment decisions. ABBREVIATIONS: A1C = hemoglobin A1C ACE = American College of Endocrinology ACS = acute coronary syndrome AHA = American Heart Association ASCVD = atherosclerotic cardiovascular disease ATP = Adult Treatment Panel apo = apolipoprotein BEL = best evidence level CKD = chronic kidney disease CPG = clinical practice guidelines CVA = cerebrovascular accident EL = evidence level FH = familial hypercholesterolemia HDL-C = high-density lipoprotein cholesterol HeFH = heterozygous familial hypercholesterolemia HIV = human immunodeficiency virus HoFH = homozygous familial hypercholesterolemia hsCRP = high-sensitivity C-reactive protein LDL-C = low-density lipoprotein cholesterol Lp-PLA2 = lipoprotein-associated phospholipase A2 MESA = Multi-Ethnic Study of Atherosclerosis MetS = metabolic syndrome MI = myocardial infarction NCEP = National Cholesterol Education Program PCOS = polycystic ovary syndrome PCSK9 = proprotein convertase subtilisin/kexin type 9 T1DM = type 1 diabetes mellitus T2DM = type 2 diabetes mellitus TG = triglycerides VLDL-C = very low-density lipoprotein cholesterol.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY DISEASE STATE CLINICAL REVIEW: CLINICAL RELEVANCE OF MACROPROLACTIN IN THE ABSENCE OR PRESENCE OF TRUE HYPERPROLACTINEMIA.

OBJECTIVE: To review the current literature regarding the prevalence of macroprolactin (macroPRL) in hyperprolactinemic patients and determine recommendations for testing. METHODS: An electronic United States National Library of Medicine PubMed search (through October, 2014) was conducted for search term "macroprolactin." Only English-language articles were considered. RESULTS: MacroPRL is an under-recognized cause of elevated prolactin (PRL) and is present in approximately 4% to 40% of hyperprolactinemic patients depending on the referral population. Clinical findings which could be due to hyperprolactinemia are the impetus for testing for PRL. Because of this there is significant overlap in the clinical presentation of patients with true hyperprolactinemia and those with macroPRL, differentiation cannot always be made on the basis of symptoms. A lack of recognition of the presence of macroPRL can lead to unnecessary laboratory investigations, imaging, and pharmacologic or surgical treatment. CONCLUSION: Until there is a commercially available PRL assay that is not subject to interference by macroPRL, clinicians should consider the possibility of macroPRL, especially if the clinical presentation, imaging findings, and/or response to therapy reveal inconsistencies.

Prevalence and cost of possibly unnecessary venous blood glucose measurements in primary care.

The American Diabetes Association issues annually its recommendations for diabetes mellitus screening. Although there is a high proportion of people with undiagnosed diabetes in the general population, it is suspected that many of these screening tests could be needless. An analysis was made of the number of venous blood glucose measurements that did not meet the American Diabetes Association requirements performed in 150 people seen in primary care. On average, an unnecessary venous blood glucose measurement is performed every 15 months. The number is significantly higher in people over 45 years of age, and also in women as compared to men (although with a p value slighty higher than 0.05).

A comparison of cost per case detected of screening strategies for Type 2 diabetes and impaired glucose regulation: modelling study.

BACKGROUND: To determine a cost per case detected for different screening strategies for both Type 2 diabetes alone and in combination with impaired glucose regulation. METHODS: Bayesian framework modelling study using data from the ADDITION-Leicester screening study in UK multi-ethnic primary care setting. There were 5794 people aged 40-75 years (77.4% white European; 22.6% south Asian) without previously known diabetes. We compared 212 screening strategies including blood tests, a computer practice data score and a risk score, as part of a multi-stage process that all used an oral glucose tolerance test as the diagnostic test. Simulation models were created using sensitivity estimates for the expected cost per case. RESULTS: The estimated costs per case identified for the 18 most sensitive strategies varied from £457 to £1639 (€526-1886, for £1=€1.15) for diabetes and £148-913 (€170-1050) for both diabetes and impaired glucose regulation. The lowest costing diabetes strategies ranged from £457 to £523 (€526-601) involving a two-stage screening strategy, a non-invasive risk stratifying tool followed by a blood test, producing sensitivities ranging from 67.1 to 82.4%. CONCLUSION: Screening a population using a non-invasive risk stratification tool followed by a screening blood test is the most cost-effective method of screening for diabetes and abnormal glucose tolerance.

[Budget impact of growth hormone treatment during the transition phase between childhood and adulthood]. / Impacto presupuestario de la utilización de hormona de crecimiento de la edad pediátrica a la adulta.

OBJECTIVE: To estimate the budget impact of somatrophin (Genotonorm) use in growth hormone deficiency (GHD) patients during the transition between childhood and adulthood. METHOD: A budget impact model was designed under the Spanish National Health System with a 5-year time horizon. Calculations of susceptible patients were based on disease prevalence (0.02%) applied to Spanish population. From total GHD cases, 60% was considered persistent and treatment candidates. An expert panel assumed that 20% of candidates would reject the treatment and 8% would withdraw therapy annually. Considered costs included: therapy costs, diagnosis (test and medical visit) and follow-up cost. RESULTS: There would be 49, 93, 132, 186 and 199 patients undergoing treatment each year (2010-2014). The total impact of Genotonorm use during the transition phase would be €367,691, €655,430, €1044,874, €1334,059, and €1594,670 for years 1 to 5. The average annual cost per patient would be €7506, €7059, €7903, €7960, €7995. CONCLUSIONS: GHD treatment during the transition phase in Spain poses an annual average layout of €7684/patient.

[Calcitonin: indications and interpretation]. / Dosages de la calcitonine : indications et interprétation.

Calcitonin is the sensitive and specific marker of the medullary thyroid cancers. It is a diagnostic, pronostic and follow-up marker. Medullary thyroid cancer is a rare disease representing 4% of the thyroid cancers and occurring in 0.4% of nodular thyroid pathology. The use of sex specific adults normal ranges allows a better interpretation of the moderately elevated calcitonin levels. Hypercalcitoninaemia non due to medullary thyroid cancer are attributed mainly to male sex, tobacco use, overweight, renal failure and other endocrine tumors. CT is associated to carcinoembryonic antigen and possible procalcitonin assays. Calcitonin can be assayed in the wash-out fluid of the fine needle aspiration too. Stimulation tests give poor additional diagnostic information and are about to be abandoned.

Calcitonin measurement in the evaluation of thyroid nodules in the United States: a cost-effectiveness and decision analysis.

CONTEXT: European studies have shown that the use of routine calcitonin screening for detection of medullary thyroid cancer (MTC) in patients with thyroid nodules increases the detection of occult MTC and may improve patient outcomes. Calcitonin screening for MTC has not been recommended in recent U.S. practice guidelines. OBJECTIVE: Our objective was to determine the cost-effectiveness (C/E) of routine calcitonin screening in adult patients with thyroid nodules in the United States. SETTINGS/SUBJECTS: A decision model was developed for a hypothetical group of adult patients presenting for evaluation of thyroid nodules in the United States. Patients were screened using current American Thyroid Association guidelines only, or American Thyroid Association guidelines with routine serum calcitonin screening. Input data were obtained from the literature, the Surveillance Epidemiology and End Results and Healthcare Cost and Utilization Project's Nationwide Inpatient Sample databases, and the Medicare Reimbursement Schedule. Sensitivity analyses were performed for a number of input variables. MAIN OUTCOME MEASURES: C/E, measured in dollars per life years saved (LYS), was calculated. RESULTS: Addition of calcitonin screening to current American Thyroid Association guidelines for the evaluation of thyroid nodules would cost $11,793 per LYS ($10,941-$12,646). When extrapolated to the national level, calcitonin screening for MTC in the United States would yield an additional 113,000 life years at a cost increase of 5.3%. Calcitonin screening C/E is sensitive to patient age and gender, and to changes in disease prevalence, specificity of fine needle aspiration and calcitonin testing, calcitonin screening level, costs of testing, and length of follow-up. CONCLUSION: Routine serum calcitonin screening in patients undergoing evaluation for thyroid nodules appears to be cost effective in the United States, with C/E comparable to the measurement of thyroid stimulating hormone, colonoscopy, and mammography screening.

The ongoing debate in thyroid surgery: should frozen section analysis be omitted?

Controversies concerning the role of frozen section (FS) have been a matter of debate. The aim of this study was to identify the role of FS analysis in intraoperative decision making and analyze the effect of the cost in detecting thyroid malignancies in Turkey. Out of 214 consecutive patients who had been operated on for thyroid cancer between January 1996 and August 2004, 178 patients were evaluated retrospectively. All 178 patients were subjected to FS. Intraoperative FS correctly identified the pathology as malignant in 58.4% of patients. A true-positive FS result changed the surgical strategy in 30 (27.6%) cases False negative FS lesions were defined histologically as papillary microcarcinoma in 54%, follicular variant of papillary cancer in 18% and follicular cancer in 8% of cases. The sensitivities of FNAB and intraoperative FS in thyroid cancer patients were 22.5% and 58.4%, respectively. False negative FS results increased the cost for each informative FS from euro25 to euro42.7. Despite limitations, results of this study reject the idea that the role of FS is becoming limited. We recommend routine frozen section in the operative assessment of thyroid nodules. Omitting FS may be suggested only in cases with a FNAB revealing malignancy.

[Hypothyroidism: clinical and economical implications in a health area]. / Hipotiroidismo: implicaciones clínicas y económicas en un área de salud.

OBJECTIVE: To analyze the clinical, biochemical and epidemiological characteristics in patients with hypothyroidism, substitutive dose and annual direct costs, in a health area. MATERIAL AND METHODS: Seventy five patients attended in a health area were included in the review. Data was divided in epidemiological, biochemical, clinics and economics. RESULTS: A 94.7% were females and 5.3% males, with an average age of 52.07 + 16.5 years. The most frequent disease was Thyroiditis of Hashimoto 48% and atrophic thyroiditis 46.6%. Average value of TSH was 17.57 + 40.8 mUI/ml and TPO 629.3 + 1049 UI/ml and Ac TG 532.1 + 1028 UI/ml. A 58.7% of patients had goiter, only evident 2.6%. The average dose of T4 was 81 + 53.5 mg/day. The average number of visits was 2.67 + 1.08. The highest cost was due to specialists visit 160 + 65 euros with a total average cost of 212.9 + 81.5 euros. Levels of TPO was higher in T. Hashimoto, with a higher number of visits and costs. CONCLUSIONS: The most prevalent disease was autoimmune (T Hashimoto and atrophic thyroiditis) with higher levels of TPO in Hashimoto. Total cost is higher in T. Hashimoto.