American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis — 2016--Executive Summary

Abbreviations:AACE = American Association of Clinical EndocrinologistsAFF = atypical femur fractureASBMR = American Society for Bone and Mineral ResearchBEL = best evidence levelBMD = bone mineral densityBTM = bone turnover markerCBC = complete blood countCI = confidence intervalDXA = dual-energy X-ray absorptiometryEL = evidence levelFDA = U.S. Food and Drug AdministrationFLEX = Fracture Intervention Trial (FIT) Long-term ExtensionFRAX® = Fracture Risk Assessment ToolGFR = glomerular filtration rateGI = gastrointestinalHORIZON = Health Outcomes and Reduced Incidence with Zoledronic Acid Once YearlyIOF = International Osteoporosis FoundationISCD = International Society for Clinical DensitometryIU = international unitsIV = intravenousLSC = least significant changeNBHA = National Bone Health AllianceNOF = National Osteoporosis Foundation25(OH)D = 25-hydroxy vitamin DONJ = osteonecrosis of the jawPINP = serum carboxy-terminal propeptide of type I collagenPTH = parathyroid hormoneR = recommendationRANK = receptor activator of nuclear factor kappa-BRANKL = receptor activator of nuclear factor kappa-B ligandRCT = randomized controlled trialRR = relative riskS-CTX = serum C-terminal telopeptideSQ = subcutaneousVFA = vertebral fracture assessmentWHO = World Health Organization     

American Association of Clinical Endocrinologists/American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis— 2020 Update Executive Summary

Objective: The development of these guidelines is sponsored 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: Recommendations are based on diligent reviews of the clinical evidence with transparent incorporation of subjective factors, according to established AACE/ACE guidelines for guidelines protocols.Results: The Executive Summary of this 2020 updated guideline contains 52 recommendations: 21 Grade A (40%), 24 Grade B (46%), 7 Grade C (14%), and no Grade D (0%). These detailed, evidence-based recommendations allow for nuance-based clinical decision-making that addresses multiple aspects of real-world care of patients. The evidence base presented in the subsequent Appendix provides relevant supporting information for the Executive Summary recommendations. This update contains 368 citations: 123 (33.5%) evidence level (EL) 1 (highest), 132 (36%) EL 2 (intermediate), 20 (5.5%) EL 3 (weak), and 93 (25%) EL 4 (lowest). New or updated topics in this CPG include: clarification of the diagnosis of osteoporosis, stratification of the patient according to high-risk and very-high-risk features, a new dual-action therapy option, and transitions from therapeutic options.Conclusion: This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of post-menopausal osteoporosis.     

American Association of Clinical Endocrinologists and American College of Endocrinology – Clinical Practice Guidelines for Developing A Diabetes Mellitus Comprehensive Care Plan – 2015 — Executive Summary

The American Association of Clinical Endocrinologists/American College of Endocrinology Medical Guidelines for Clinical Practice are systematically developed statements to assist healthcare professionals in medical decision making for specific clinical conditions. Most of the content herein is based on literature reviews. In areas of uncertainty, professional judgment was applied. These guidelines are a working document that reflects the state of the field at the time of publication. Because rapid changes in this area are expected, periodic revisions are inevitable. We encourage medical professionals to use this information in conjunction with their best clinical judgment. The presented recommendations may not be appropriate in all situations. Any decision by practitioners to apply these guidelines must be made in light of local resources and individual patient circumstances.Abbreviations: A1C = hemoglobin A1c AACE = American Association of Clinical Endocrinologists ACCORD = Action to Control Cardiovascular Risk in Diabetes ACE = angiotensin-converting enzyme ADA = American Diabetes Association AER = albumin excretion rate ApoB = apolipoprotein B ARB = angiotensin II receptor blocker ASCVD = atherosclerotic cardiovascular disease BEL = best evidence level BMI = body mass index CDC = Centers for Disease Control and Prevention CDE = certified diabetes educator CGM = continuous glucose monitoring CKD = chronic kidney disease CPAP = continuous positive airway pressure CPG = clinical practice guideline CSI = continuous subcutaneous insulin infusion CVD = cardiovascular disease DPP-4 = dipeptidyl peptidase 4 DSME = diabetes self-management education DSPN = distal symmetric polyneuropathy EL = evidence level ESRD = end-stage renal disease FDA = U.S. Food and Drug Administration FPG = fasting plasma glucose GDM = gestational diabetes mellitus GFR = glomerular filtration rate GLP-1 = glucagon-like peptide 1 HBV = hepatitis B virus HDL-C = high-density lipoprotein cholesterol HR = hazard ratio ICU = intensive care unit IFG = impaired fasting glucose IGT = impaired glucose tolerance ISF = insulin sensitivity factor LDL-C = low-density lipoprotein cholesterol LDL-P = low-density lipoprotein particles MDI = multiple daily injections MNT = medical nutrition therapy NPH = neutral protamine Hagedorn OGTT = oral glucose tolerance test OSA = obstructive sleep apnea PG = plasma glucose POC = point-of-care PPG = postprandial glucose PTH = parathyroid hormone Q = clinical question R = recommendation RAAS = reninangiotensin-aldosterone system RCT = randomized controlled trial SFN = small-fiber neuropathy SGLT2 = sodium glucose cotransporter 2 SMBG = self-monitoring of blood glucose T1D = type 1 diabetes T2D = type 2 diabetes TZD = thiazolidinedione     

Protocol for Development of American Association of Clinical Endocrinology Clinical Practice Guidelines and Consensus Statements: Summary of Methodology,Process, and Policy – 2023 Update

ObjectiveThis 2023 updated protocol summarizes the American Association of Clinical Endocrinology’s (AACE’s) new framework for the development of clinical practice guidelines and other guidance documents that includes changes to methodology, processes, and policies.MethodsAACE has critically reviewed its development processes for guidance documents over the last several years against the National Academy of Medicine Standards for Developing Trustworthy Clinical Practice Guidelines and the Council of Medical Specialty Societies Principles for Development of Specialty Society Clinical Guidelines to determine areas for improvement.ResultsThe new AACE framework for development of guidance documents incorporates many changes, including a revised conflicts of interest (COI) policy; strengthened commitment to collection of disclosures and management of relevant COI during development; open calls to membership for authors; new requirements for authors; new diversity, equity, and inclusion (DEI) policy; new empanelment process that incorporates consideration of DEI; and adoption of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to increase the quality of evidence assessment and standardize recommendation grades and statements, among other improvements.ConclusionsAACE has revised its policies and adopted a completely new methodology for guideline development in support of the mission to elevate the practice of clinical endocrinology to improve patient care. With the use of an evidence-based medicine framework and by continually assessing and improving its processes for development of guidance, AACE strives to deliver trustworthy, unbiased, and up-to-date information that ensures clinician and patient confidence in AACE content. Further, AACE hopes that these enhancements foster a more collaborative approach to development and increase engagement with the worldwide medical community to improve global health.     

American Association of Clinical Endocrinology Consensus Statement: Comprehensive Type 2 Diabetes Management Algorithm – 2023 Update

ObjectiveThis consensus statement provides (1) visual guidance in concise graphic algorithms to assist with clinical decision-making of health care professionals in the management of persons with type 2 diabetes mellitus to improve patient care and (2) a summary of details to support the visual guidance found in each algorithm.MethodsThe American Association of Clinical Endocrinology (AACE) selected a task force of medical experts who updated the 2020 AACE Comprehensive Type 2 Diabetes Management Algorithm based on the 2022 AACE Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan and consensus of task force authors.ResultsThis algorithm for management of persons with type 2 diabetes includes 11 distinct sections: (1) Principles for the Management of Type 2 Diabetes; (2) Complications-Centric Model for the Care of Persons with Overweight/Obesity; (3) Prediabetes Algorithm; (4) Atherosclerotic Cardiovascular Disease Risk Reduction Algorithm: Dyslipidemia; (5) Atherosclerotic Cardiovascular Disease Risk Reduction Algorithm: Hypertension; (6) Complications-Centric Algorithm for Glycemic Control; (7) Glucose-Centric Algorithm for Glycemic Control; (8) Algorithm for Adding/Intensifying Insulin; (9) Profiles of Antihyperglycemic Medications; (10) Profiles of Weight-Loss Medications (new); and (11) Vaccine Recommendations for Persons with Diabetes Mellitus (new), which summarizes recommendations from the Advisory Committee on Immunization Practices of the U.S. Centers for Disease Control and Prevention.ConclusionsAligning with the 2022 AACE diabetes guideline update, this 2023 diabetes algorithm update emphasizes lifestyle modification and treatment of overweight/obesity as key pillars in the management of prediabetes and diabetes mellitus and highlights the importance of appropriate management of atherosclerotic risk factors of dyslipidemia and hypertension. One notable new theme is an emphasis on a complication-centric approach, beyond glucose levels, to frame decisions regarding first-line pharmacologic choices for the treatment of persons with diabetes. The algorithm also includes access/cost of medications as factors related to health equity to consider in clinical decision-making.     

Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2020 Executive Summary

Abbreviations: A1C = hemoglobin A1C; AACE = American Association of Clinical Endocrinologists; ABCD = adiposity-based chronic disease; ACCORD = Action to Control Cardiovascular Risk in Diabetes; ACCORD BP = Action to Control Cardiovascular Risk in Diabetes Blood Pressure; ACE = American College of Endocrinology; ACEI = angiotensin-converting enzyme inhibitor; AGI = alpha-glucosidase inhibitor; apo B = apolipoprotein B; ARB = angiotensin II receptor blocker; ASCVD = atherosclerotic cardiovascular disease; BAS = bile acid sequestrant; BMI = body mass index; BP = blood pressure; CCB = calcium channel blocker; CGM = continuous glucose monitoring; CHD = coronary heart disease; CKD = chronic kidney disease; DKA = diabetic ketoacidosis; DPP4 = dipeptidyl peptidase 4; eGFR = estimated glomerular filtration rate; EPA = eicosapentaenoic acid; ER = extended release; FDA = Food and Drug Administration; GLP1 = glucagon-like peptide 1; HDL-C = high-density-lipoprotein cholesterol; HeFH = heterozygous familial hypercholesterolemia; LDL-C = low-density-lipoprotein cholesterol; LDL-P = low-density-lipoprotein particle; Look AHEAD = Look Action for Health in Diabetes; NPH = neutral protamine Hagedorn; OSA = obstructive sleep apnea; PCSK9 = proprotein convertase subtilisin-kexin type 9 serine protease; RCT = randomized controlled trial; SU = sulfonylurea; SGLT2 = sodium-glucose cotransporter 2; SMBG = self-monitoring of blood glucose; T2D = type 2 diabetes; TZD = thiazolidinedione     

Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2018 Executive Summary

Abbreviations: A1C = hemoglobin A1C; AACE = American Association of Clinical Endocrinologists; ACCORD = Action to Control Cardiovascular Risk in Diabetes; ACCORD BP = Action to Control Cardiovascular Risk in Diabetes Blood Pressure; ACEI = angiotensin-converting enzyme inhibitor; ADVANCE = Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation; AGI = alpha-glucosidase inhibitor; apo B = apolipoprotein B; ASCVD = atherosclerotic cardiovascular disease; BAS = bile acid sequestrant; BCR-QR = bromocriptine quick release; BMI = body mass index; BP = blood pressure; CCB = calcium channel blocker; CHD = coronary heart disease; CKD = chronic kidney disease; CVD = cardiovascular disease; DASH = Dietary Approaches to Stop Hypertension; DPP4 = dipeptidyl peptidase 4; eGFR = estimated glomerular filtration rate; ER = extended release; FDA = Food and Drug Administration; GLP1 = glucagon-like peptide 1; HDL-C = high-density lipoprotein cholesterol; IMPROVE-IT = Improved Reduction of Outcomes: Vytorin Efficacy International Trial; LDL-C = low-density lipoprotein cholesterol; LDL-P = low-density lipoprotein particle; Look AHEAD = Look Action for Health in Diabetes; NPH = neutral protamine Hagedorn; OSA = obstructive sleep apnea; RCT = randomized controlled trial; SU = sulfonylurea; SGLT2 = sodium glucose cotransporter-2; SMBG = self-monitoring of blood glucose; T2D = type 2 diabetes; TZD = thiazolidinedione; VADT = Veterans Affairs Diabetes Trial     

Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2019 Executive Summary

Abbreviations: A1C = hemoglobin A1C; AACE = American Association of Clinical Endocrinologists; ACCORD = Action to Control Cardiovascular Risk in Diabetes; ACCORD BP = Action to Control Cardiovascular Risk in Diabetes Blood Pressure; ACE = American College of Endocrinology; ACEI = angiotensin-converting enzyme inhibitor; AGI = alpha-glucosidase inhibitor; apo B = apolipoprotein B; ARB = angiotensin II receptor blocker; ASCVD = atherosclerotic cardiovascular disease; BAS = bile acid sequestrant; BMI = body mass index; BP = blood pressure; CCB = calcium channel blocker; CGM = continuous glucose monitoring; CHD = coronary heart disease; CKD = chronic kidney disease; DKA = diabetic ketoacidosis; DPP4 = dipeptidyl peptidase 4; eGFR = estimated glomerular filtration rate; EPA = eicosapentaenoic acid; ER = extended release; FDA = Food and Drug Administration; GLP1 = glucagon-like peptide 1; HDL-C = high-density-lipoprotein cholesterol; HeFH = heterozygous familial hypercholesterolemia; LDL-C = low-density-lipoprotein cholesterol; LDL-P = low-density-lipoprotein particle; Look AHEAD = Look Action for Health in Diabetes; NPH = neutral protamine Hagedorn; OSA = obstructive sleep apnea; PCSK9 = proprotein convertase subtilisin-kexin type 9 serine protease; RCT = randomized controlled trial; SU = sulfonylurea; SGLT2 = sodium-glucose cotransporter 2; SMBG = self-monitoring of blood glucose; T2D = type 2 diabetes; TZD = thiazolidinedione     

Transcultural Diabetes Care in The United States – A Position Statement by the American Association of Clinical Endocrinologists

The American Association of Clinical Endocrinologists (AACE) has created a transculturalized diabetes chronic disease care model that is adapted for patients across a spectrum of ethnicities and cultures. AACE has conducted several transcultural activities on global issues in clinical endocrinology and completed a 3-city series of conferences in December 2017 that focused on diabetes care for ethnic minorities in the U.S. Proceedings from the “Diabetes Care Across America” series of transcultural summits are presented here. Information from community leaders, practicing health care professionals, and other stakeholders in diabetes care is analyzed according to biological and environmental factors. Four specific U.S. ethnicities are detailed: African Americans, Latino/Hispanics, Asian Americans, and Native Americans. A core set of recommendations to culturally adapt diabetes care is presented that emphasizes culturally appropriate terminology, transculturalization of white papers, culturally adapting clinic infrastructure, flexible office hours, behavioral medicine—especially motivational interviewing and building trust—culturally competent nutritional messaging and health literacy, community partnerships for care delivery, technology innovation, clinical trial recruitment and retention of ethnic minorities, and more funding for scientific studies on epigenetic mechanisms of cultural impact on disease expression. It is hoped that through education, research, and clinical practice enhancements, diabetes care can be optimized in terms of precision and clinical outcomes for the individual and U.S. population as a whole.Lay AbstractThe American Association of Clinical Endocrinologists (AACE) has created a diabetes care model for patients of different backgrounds. AACE led meetings in New York, Houston, and Miami with health care professionals and community leaders to improve diabetes care. Information from these meetings looked at biological and environmental diabetes risks. Four American patient groups were studied: African Americans, Latinos, Asian Americans, and Native Americans. Diabetes care should use culturally appropriate language and search for better ways to apply science and clinic design. Talking to patients more clearly can improve their diabetes control. There are many other needed changes in the American health care system discussed in this paper. It is hoped that through better education, research, and practice, diabetes care can be improved for the entire U.S. population. This means that important differences among patients' ethnic and cultural backgrounds are addressed.Executive Summary

• Cultural adaptation of evidence-based recommendations is a necessary component of optimal diabetes care.
• Biological factors that contribute to the pathophysiology of diabetes vary according to race and ethnicity and can be affected by social determinants that vary with culture.
• The “Transcultural Diabetes Nutrition Algorithm” was developed in 2010 to optimize diabetes nutrition care globally and represents a validated methodology where evidence-based recommendations from a source culture can be adapted and implemented in a different culture using a toolkit.
• The 2015 AACE Pan-American Workshop examined diabetes care in 9 Latin American nations and concluded that there should only be one level of diabetes care for a population and that level should be “excellent;” also, that A1C measurements should be utilized and that more educational and nutritional options are needed to optimize diabetes care.
• The “Diabetes Care Across America – A Series of Transcultural Summits” was an AACE program conducted in 2017 in New York, Houston, and Miami to examine cultural factors that influence diabetes care domestically; the findings of this program are presented here.
• The African American, Hispanic/Latino, Asian American, and Native American populations are each comprised of different ancestries, anthropometrics/body compositions and physical appearances, and cultures and degrees of acculturation, with a significant evidence base that associates specific gene variants with specific phenotypic traits affecting diabetes care.
• For each ethno-cultural population, health messaging and diabetes care will need to consider issues of potential distrust of health care professionals, history of discrimination, religious practices, food preferences, attitudes toward physical activity, and despite the full range of socio-economics, the impact of poverty on engagement, self-monitoring, adherence with lifestyle and medical recommendations, and recruitment for clinical trials.
• Diabetes care should be as precise as possible, incorporating clinical trial evidence that best reflects the ethno-cultural attributes of a specific patient, with particular emphasis on cardiovascular disease risk mitigation, technology to assess the effects of eating patterns on glycemic status, adjusting traditional eating patterns to more healthy options that are still acceptable to the patient, flexibility in lifestyle and medication recommendations that take into account cultural factors, and the utilization of community-based resources to improve implementation.
• Pragmatic first steps to prepare a diabetes practice for an ethno-culturally diverse patient population include: learning more about biological-cultural interactions; gaining experience with lifestyle and behavioral medicine, especially motivational interviewing; creating a safe and immersive clinical environment; incorporating translation services, social prescribing, wearable technologies, web-based resources, and community engagement; and establishing referral networks with clinical trialists in diabetes research to improve recruitment of different populations.

ABSTRACTAbbreviations: A1C = hemoglobin A1c; AACE = American Association of Clinical Endocrinologists; ABCD = adiposity-based chronic disease; BMI = body mass index; CPA = clinical practice algorithm; CPG = clinical practice guideline; DBCD = dysglycemia-based chronic disease; DPP = Diabetes Prevention Program; GWAS = genome-wide association study; HCP = health care professional(s); IHS = Indian Health Service; LDL = low-density lipoprotein; MetS = metabolic syndrome; T2D = type 2 diabetes mellitus; tDNA = transcultural Diabetes Nutrition Algorithm; TG = triglyceride; WC = waist circumference     

Clinical trials of endothelin antagonists in heart failure: a question of dose?

Circulating plasma endothelin (ET)-1 concentrations are substantially elevated, and correlate with the hemodynamic severity and New York Heart Association (NYHA) class, in patients with chronic heart failure (CHF). In early preclinical studies involving different models of experimental heart failure, ET antagonists reduced cardiac pressures, increased cardiac output, and prolonged survival. ET receptor antagonists also impressively improved systemic and pulmonary hemodynamics in patients with CHF, without causing neurohormonal activation. However, recent clinical trials, including the ENABLE (Endothelin Antagonist Bosentan for Lowering Cardiac Events in Heart Failure) and EARTH (Endothelin A Receptor Antagonist Trial in Heart Failure) studies, have shown neutral effects in terms of mortality and symptoms. This paper describes the possible reasons why benefit was not seen in these clinical studies, and suggests what lessons can be learnt from the way the studies were undertaken to apply to future studies.     

Outfoxing a Rash: Clinical Example of Human–Wildlife Interaction

Increasing human–wildlife contact can manifest in a variety of clinical conditions that may be overlooked by both human health and veterinary professionals. We report on an outbreak of scabies infection in a community, affecting both animals and humans, and representing the effects of an emerging infectious disease in a wildlife population. These cases underscore the potential importance of animal sentinel events for human, animal, and ecosystem health. The treatment given to the human cases of infection ranged from aggressive therapy to watchful waiting, with similar outcomes. There is a need for further collaborative, evidence-based research by human and veterinary health professionals into the optimal treatment and prevention of infections resulting from cross-species transmission.     

The American genera of Malvaceae—II

The genera of Malvaceae that occur in North, Central, and South America (including the Caribbean) are enumerated, described, and distinguished, using an artificial key. The usual taxonomic information (bibliographic citations, synonyms, type species, etc.) is presented and the generic names are indexed. The literature is reviewed and summarized for each genus, presenting such information (where appropriate) as the etymology of the name, number of species, infrageneric classification, distribution, chromosome numbers, economic importance, distinguishing features, and reference to representative illustrations. Where useful, the taxonomic history of the genus is summarized. A listing of unresolved taxonomic problems in the family is presented to highlight needs for future study. A detailed bibliography is included. One new combination is made:Palaua sandemanii (Sandwith) Fryxell, based on the PeruvianMalvastrum sandemanii Sandwith.

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Resumen  Los géneros de la familia Malvaceae que se encuentran en Norte América, Centroamérica, y Sudamérica (incluyendo Las Antillas) se enumeran, describen, y distinguen por medio de una clave artificial. Se presentan informaciones tales como citas bibliográficas, sinonimías, y especies tipos para cada género, y se presenta un índice de los nombres, genéricos. Para cada género del que existe información, se presentan datos derivados de la literatura sobre su etimología, número de especies, clasificación infragenérica, distribución geográfica, números cromosómicos, importancia económica, características destacables, y referencias de ilustraciones representativas. Cuando se considera necesario, se presenta la historia taxonómica del género. Se presenta un lista de aquellos problemas taxonómicos no resueltos en la familia y se indican los estudios necesarios para el futuro. Se acompanya una bibliografía detallada. Se hace una combinación nueva:Palaua sandemanii (Sandwith) Fryxell, basada enMalvastrum sandemanii Sandwith.

     

Guayule—An American source of rubber

Over three million acres of marginal farm land in the United States are capable of producing guayule rubber. Use of existing strains on these lands would produce 200,000 long tons of natural rubber per year. Plant breeding and process research could raise this to at least 300,000 long tons, or about half of our annual consumption of natural rubber.