American Association Of Clinical Endocrinologists And American College Of Endocrinology Position Statement On Thyroid Dysfunction Case Finding

Hypothyroidism and hyperthyroidism can be readily diagnosed and can be treated in a safe, cost-effective manner. Professional organizations have given guidance on how and when to employ thyroid-stimulating hormone testing for the detection of thyroid dysfunction. Most recently, the United States Preventive Services Task Force did not endorse screening for thyroid dysfunction based on a lack of proven benefit and potential harm of treating those with thyroid dysfunction, which is mostly subclinical disease. The American Association of Clinical Endocrinologists (AACE) is concerned that this may discourage physicians from testing for thyroid dysfunction when clinically appropriate. Given the lack of specificity of thyroid-associated symptoms, the appropriate diagnosis of thyroid disease requires biochemical confirmation. The Thyroid Scientific Committee of the AACE has produced this White Paper to highlight the important difference between screening and case-based testing in the practice of clinical medicine. We recommend that thyroid dysfunction should be frequently considered as a potential etiology for many of the nonspecific complaints that physicians face daily. The application and success of safe and effective interventions are dependent on an accurate diagnosis. We, therefore, advocate for an aggressive case-finding approach, based on identifying those persons most likely to have thyroid disease that will benefit from its treatment.Abbreviations:AACE = American Association of Clinical EndocrinologistsATA = American Thyroid AssociationFT4 = free thyroxineIHD = ischemic heart diseaseTSH = thyroid-stimulating hormoneUSPSTF = United States Preventive Services Task Force     

The Use of Vitamins and Minerals in Skeletal Health: American Association of Clinical Endocrinologists and the American College of Endocrinology Position Statement

Abbreviations: 25(OH)D = 25-hydroxyvitamin D; BMD = bone mineral density; CV = cardiovascular; GI = gastrointestinal; IOM = Institute of Medicine; PTH = parathyroid hormone; RCT = randomized controlled trial; αTF = α-tocopherol; ucOC = undercarboxylated osteocalcin; VKA = vitamin K antagonist; WHI = Women's Health Initiative     

American Association of Clinical Endocrinologists and American College of Endocrinology Position Statement on the Association of SGLT-2 Inhibitors and Diabetic Ketoacidosis

Abbreviations:AACE = American Association of Clinical EndocrinologistsACE = American College of EndocrinologyDKA = diabetic ketoacidosisEMA = European Medicines AgencyFDA = U.S. Food and Drug AdministrationSGLT-2 = sodium glucosecotransporter 2T1D = type 1 diabetesT2D = type 2 diabetes     

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

Abbreviations:A1C = glycated hemoglobinAGP = ambulatory glucose profileARD = absolute relative differenceBGM = blood glucose monitoringCGM = continuous glucose monitoringCMS = Centers for Medicare and Medicaid ServicesCSII = continuous subcutaneous insulin infusionCV = coefficient of variationDCCT = Diabetes Control and Complications TrialDirecNet = Diabetes Research in Children NetworkFDA = US Food & Drug AdministrationGDM = gestational diabetes mellitusGM = glucose monitoringIDF = International Diabetes FederationISO = International Organization for StandardizationMARD = mean absolute relative differenceMDI = multiple daily injectionsMedARD = median absolute relative differenceMNT = medical nutrition therapySAP = sensor-augmented pumpT1DM = type 1 diabetes mellitusT2DM = type 2 diabetes mellitus     

Statement by an American Association of Clinical Endocrinologists/ American College of Endocrinology Consensus Panel on Type 2 Diabetes Mellitus: An Algorithm for Glycemic Control

This report presents an algorithm to assist primary care physicians, endocrinologists, and others in the management of adult, nonpregnant patients with type 2 diabetes mellitus. In order to minimize the risk of diabetes-related complications, the goal of therapy is to achieve a hemoglobin A1c (A1C) of 6.5% or less, with recognition of the need for individualization to minimize the risks of hypoglycemia. We provide therapeutic pathways stratified on the basis of current levels of A1C, whether the patient is receiving treatment or is drug naïve. We consider monotherapy, dual therapy, and triple therapy, including 8 major classes of medications (biguanides, dipeptidyl-peptidase-4 inhibitors, incretin mimetics, thiazolidinediones, α-glucosidase inhibitors, sulfonylureas, meglitinides, and bile acid sequestrants) and insulin therapy (basal, premixed, and multiple daily injections), with or without orally administered medications. We prioritize choices of medications according to safety, risk of hypoglycemia, efficacy, simplicity, anticipated degree of patient adherence, and cost of medications. We recommend only combinations of medications approved by the US Food and Drug Administration that provide complementary mechanisms of action. It is essential to monitor therapy with A1C and self-monitoring of blood glucose and to adjust or advance therapy frequently (every 2 to 3 months) if the appropriate goal for each patient has not been achieved. We provide a flowchart and table summarizing the major considerations. This algorithm represents a consensus of 14 highly experienced clinicians, clinical researchers, practitioners, and academicians and is based on the American Association of Clinical Endocrinologists/American College of Endocrinology Diabetes Guidelines and the recent medical literature. (Endocr Pract. 2009;15:540-559)     

Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Quality of DXA Scans and Reports

Objective: High-quality dual-energy X-ray absorptiometry (DXA) scans are necessary for accurate diagnosis of osteoporosis and monitoring of therapy; however, DXA scan reports may contain errors that cause confusion about diagnosis and treatment. This American Association of Clinical Endocrinologists/American College of Endocrinology consensus statement was generated to draw attention to many common technical problems affecting DXA report conclusions and provide guidance on how to address them to ensure that patients receive appropriate osteoporosis care.Methods: The DXA Writing Committee developed a consensus based on discussion and evaluation of available literature related to osteoporosis and osteodensitometry.Results: Technical errors may include errors in scan acquisition and/or analysis, leading to incorrect diagnosis and reporting of change over time. Although the International Society for Clinical Densitometry advocates training for technologists and medical interpreters to help eliminate these problems, many lack skill in this technology. Suspicion that reports are wrong arises when clinical history is not compatible with scan interpretation (e.g., dramatic increase/decrease in a short period of time; declines in previously stable bone density after years of treatment), when different scanners are used, or when inconsistent anatomic sites are used for monitoring the response to therapy. Understanding the concept of least significant change will minimize erroneous conclusions about changes in bone density.Conclusion: Clinicians must develop the skills to differentiate technical problems, which confound reports, from real biological changes. We recommend that clinicians review actual scan images and data, instead of relying solely on the impression of the report, to pinpoint errors and accurately interpret DXA scan images.Abbreviations: AACE = American Association of Clinical Endocrinologists; BMC = bone mineral content; BMD = bone mineral density; DXA = dual-energy X-ray absorptiometry; ISCD = International Society for Clinical Densitometry; LSC = least significant change; TBS = trabecular bone score; WHO = World Health Organization     

American Association of Clinical Endocrinologists and American College of Endocrinology Consensus Conference on Obesity: Building an Evidence Base for Comprehensive Action

Objective/MethodsThe American Association of Clinical Endocrinologists/American College of Endocrinology “Consensus conference on obesity: building an evidence base for comprehensive action” convened March 23-25, 2014, in Washington, D.C. The premise of the conference was that by bringing together stakeholders in U.S. obesity care, representing the biomedical and public health models, new information would emerge to formulate actionable recommendations.ResultsKey conference findings include 5 affirmed and 8 emergent concepts. These concepts include the need for a medically meaningful and actionable diagnosis of obesity, research that evaluates and refines a complications- centric clinical approach to obesity, the need for a better understanding of reimbursement mechanisms and the value associated with obesity prevention and management, increased nutrition and obesity education, and enhanced public awareness and health literacy.ConclusionNext steps include deriving a more robust medical definition of obesity, translation of the affirmed and emergent concepts into actionable recommendations in the interests of patients with obesity, and developing logistics for effective implementation. (Endocr Pract. 2014; 20:956-976)     

Dysglycemia-Based Chronic Disease: An American Association of Clinical Endocrinologists Position Statement

The American Association of Clinical Endocrinologists (AACE) has created a dysglycemia-based chronic disease (DBCD) multimorbidity care model consisting of four distinct stages along the insulin resistance-prediabetes-type 2 diabetes (T2D) spectrum that are actionable in a preventive care paradigm to reduce the potential impact of T2D, cardiometabolic risk, and cardiovascular events. The controversy of whether there is value, cost-effectiveness, or clinical benefit of diagnosing and/or managing the prediabetes state is resolved by regarding the problem, not in isolation, but as an intermediate stage in the continuum of a progressive chronic disease with opportunities for multiple concurrent prevention strategies. In this context, stage 1 represents “insulin resistance,” stage 2 “prediabetes,” stage 3 “type 2 diabetes,” and stage 4 “vascular complications.” This model encourages earliest intervention focusing on structured lifestyle change. Further scientific research may eventually reclassify stage 2 DBCD prediabetes from a predisease to a true disease state. This position statement is consistent with a portfolio of AACE endocrine disease care models, including adiposity-based chronic disease, that prioritize patient-centered care, evidence-based medicine, complexity, multimorbid chronic disease, the current health care environment, and a societal mandate for a higher value attributed to good health. Ultimately, transformative changes in diagnostic coding and reimbursement structures for prediabetes and T2D can provide improvements in population-based endocrine health care.Abbreviations: A1C = hemoglobin A1c; AACE = American Association of Clinical Endocrinologists; ABCD = adiposity-based chronic disease; CVD = cardiovascular disease; DBCD = dysglycemia-based chronic disease; FPG = fasting plasma glucose; GLP-1 = glucagon-like peptide-1; MetS = metabolic syndrome; T2D = type 2 diabetes     

American Association of Clinical Endocrinologists and American College of Endocrinology Comprehensive Clinical Practice Guidelines for Medical Care of Patients with Obesity

Objective: Development of these guidelines is mandated by the American Association of Clinical Endocrinologists (AACE) Board of Directors and the American College of Endocrinology (ACE) Board of Trustees and adheres to published AACE protocols for the standardized production of clinical practice guidelines (CPGs).Methods: Recommendations are based on diligent review of clinical evidence with transparent incorporation of subjective factors.Results: There are 9 broad clinical questions with 123 recommendation numbers that include 160 specific statements (85 [53.1%] strong [Grade A], 48 [30.0%] intermediate [Grade B], and 11 [6.9%] weak [Grade C], with 16 [10.0%] based on expert opinion [Grade D]) that build a comprehensive medical care plan for obesity. There were 133 (83.1%) statements based on strong (best evidence level [BEL] 1 = 79 [49.4%]) or intermediate (BEL 2 = 54 [33.7%]) levels of scientific substantiation. There were 34 (23.6%) evidence-based recommendation grades (Grades A-C = 144) that were adjusted based on subjective factors. Among the 1,788 reference citations used in this CPG, 524 (29.3%) were based on strong (evidence level [EL] 1), 605 (33.8%) were based on intermediate (EL 2), and 308 (17.2%) were based on weak (EL 3) scientific studies, with 351 (19.6%) based on reviews and opinions (EL 4).Conclusion: The final recommendations recognize that obesity is a complex, adiposity-based chronic disease, where management targets both weight-related complications and adiposity to improve overall health and quality of life. The detailed evidence-based recommendations allow for nuanced clinical decision-making that addresses real-world medical care of patients with obesity, including screening, diagnosis, evaluation, selection of therapy, treatment goals, and individualization of care. The goal is to facilitate high-quality care of patients with obesity and provide a rational, scientific approach to management that optimizes health outcomes and safety.Abbreviations:A1C = hemoglobin A1cAACE = American Association of Clinical EndocrinologistsACE = American College of EndocrinologyAMA = American Medical AssociationBEL = best evidence levelBMI = body mass indexCCO = Consensus Conference on ObesityCPG = clinical practice guidelineCSS = cross-sectional studyCVD = cardiovascular diseaseEL = evidence levelFDA = Food and Drug AdministrationGERD = gastroesophageal reflux diseaseHDL-c = high-density lipoprotein cholesterolIFG = impaired fasting glucoseIGT = impaired glucose toleranceLDL-c = low-density lipoprotein cholesterolMNRCT = meta-analysis of non-randomized prospective or case-controlled trialsNE = no evidencePCOS = polycystic ovary syndromeRCT = randomized controlled trialSS = surveillance studyU.S = United States     

American Association of Clinical Endocrinologists and American College of Endocrinology Disease State Clinical Review: A Neuroendocrine Approach to Patients With Traumatic Brain Injury

Objective: Traumatic brain injury (TBI) is now recognized as a major public health concern in the United States and is associated with substantial morbidity and mortality in both children and adults. Several lines of evidence indicate that TBI-induced hypopituitarism is not infrequent in TBI survivors and may contribute to the burden of illness in this population. The goal of this article is to review the published data and propose an approach for the neuroendocrine evaluation and management of these patients.Methods: To identify pertinent articles, electronic literature searches were conducted using the following keywords: “traumatic brain injury,” “pituitary,” “hypopituitarism,” “growth hormone deficiency,” “hypogonadism,” “hypoadrenalism,” and “hypothyroidism.” Relevant articles were identified and considered for inclusion in the present article.Results: TBI-induced hypopituitarism appears to be more common in patients with severe TBI. However, patients with mild TBI or those with repeated, sports-, or blast-related TBI are also at risk for hypopituitarism. Deficiencies of growth hormone and gonadotropins appear to be most common and have been associated with increased morbidity in this population. A systematic approach is advised in order to establish the presence of pituitary hormone deficiencies and implement appropriate replacement therapies.Conclusion: The presence of traumatic hypopituitarism should be considered during the acute phase as well as during the rehabilitation phase of patients with TBI. All patients with moderate to severe TBI require evaluation of pituitary function. In addition, symptomatic patients with mild TBI and impaired quality of life are at risk for hypopituitarism and should be offered neuroendocrine testing.Abbreviations: CBG = corticosteroid-binding globulin DI = diabetes insipidus GH = growth hormone IGF-1 = insulin-like growth factor 1 SIADH = syndrome of inappropriate antidiuretic hormone T₄ = thyroxine TBI = traumatic brain injury TSH = thyroid-stimulating hormone     

Continuous Glucose Monitoring: A Consensus Conference of the American Association of Clinical Endocrinologists and American College of Endocrinology

Objective/Methods: Barriers to continuous glucose monitoring (CGM) use continue to hamper adoption of this valuable technology for the management of diabetes. The American Association of Clinical Endocrinologists and the American College of Endocrinology convened a public consensus conference February 20, 2016, to review available CGM data and propose strategies for expanding CGM access.Results: Conference participants agreed that evidence supports the benefits of CGM in type 1 diabetes and that these benefits are likely to apply whenever intensive insulin therapy is used, regardless of diabetes type. CGM is likely to reduce healthcare resource utilization for acute and chronic complications, although real-world analyses are needed to confirm potential cost savings and quality of life improvements. Ongoing technological advances have improved CGM accuracy and usability, but more innovations in human factors, data delivery, reporting, and interpretation are needed to foster expanded use. The development of a standardized data report using similar metrics across all devices would facilitate clinician and patient understanding and utilization of CGM. Expanded CGM coverage by government and private payers is an urgent need.Conclusion: CGM improves glycemic control, reduces hypoglycemia, and may reduce overall costs of diabetes management. Expanding CGM coverage and utilization is likely to improve the health outcomes of people with diabetes.Abbreviations:A1C = glycated hemoglobinAACE = American Association of Clinical EndocrinologistsACE = American College of EndocrinologyASPIRE = Automation to Simulate Pancreatic Insulin ResponseCGM = continuous glucose monitoringHRQOL = health-related quality of lifeICER = incremental cost-effectiveness ratioJDRF = Juvenile Diabetes Research FoundationMARD = mean absolute relative differenceMDI = multiple daily injectionsQALY = quality-adjusted life yearsRCT = randomized, controlled trialSAP = sensor-augmented pumpSMBG = self-monitoring of blood glucoseSTAR = Sensor-Augmented Pump Therapy for A1C ReductionT1D = type 1 diabetesT2D = type 2 diabetes