ATA/AACE Guidelines CLINICAL PRACTICE GUIDELINES FOR HYPOTHYROIDISM IN ADULTS: COSPONSORED BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND THE AMERICAN THYROID ASSOCIATION Jeffrey R. Garber, MD, FACP, FACE1,2*; Rhoda H. Cobin, MD, FACP, MACE3; Hossein Gharib, MD, MACP, MACE4; James V. Hennessey, MD, FACP2; Irwin Klein, MD, FACP5; Jeffrey I. Mechanick, MD, FACP, FACE, FACN6; Rachel Pessah-Pollack, MD6,7; Peter A. Singer, MD, FACE8; Kenneth A. Woeber, MD, FRCPE9 for the American Association of Clinical Endocrinologists and American Thyroid Association Taskforce on Hypothyroidism in Adults American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice are systematically developed statements to assist health-care 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. 988 989 CLINICAL PRACTICE GUIDELINES FOR HYPOTHYROIDISM IN ADULTS: COSPONSORED BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND THE AMERICAN THYROID ASSOCIATION Jeffrey R. Garber, MD, FACP, FACE1,2*; Rhoda H. Cobin, MD, FACP, MACE3; Hossein Gharib, MD, MACP, MACE4; James V. Hennessey, MD, FACP2; Irwin Klein, MD, FACP5; Jeffrey I. Mechanick, MD, FACP, FACE, FACN6; Rachel Pessah-Pollack, MD6,7; Peter A. Singer, MD, FACE8; Kenneth A. Woeber, MD, FRCPE9 for the American Association of Clinical Endocrinologists and American Thyroid Association Taskforce on Hypothyroidism in Adults ABSTRACT these recommendations. The strength of the recommen- dations and the quality of evidence supporting each was Objective: Hypothyroidism has multiple etiologies rated according to the approach outlined in the American and manifestations. Appropriate treatment requires an Association of Clinical Endocrinologists Protocol for accurate diagnosis and is influenced by coexisting medical Standardized Production of Clinical Guidelines—2010 conditions. This paper describes evidence-based clinical update. guidelines for the clinical management of hypothyroidism Results: Topics addressed include the etiology, epide- in ambulatory patients. miology, clinical and laboratory evaluation, management, Methods: The development of these guidelines was and consequences of hypothyroidism. Screening, treatment commissioned by the American Association of Clinical of subclinical hypothyroidism, pregnancy, and areas for Endocrinologists (AACE) in association with American future research are also covered. Thyroid Association (ATA). AACE and the ATA assem- Conclusions: Fifty-two evidence-based recommenda- bled a task force of expert clinicians who authored this tions and subrecommendations were developed to aid in article. The authors examined relevant literature and the care of patients with hypothyroidism and to share what took an evidence-based medicine approach that incor- the authors believe is current, rational, and optimal medi- porated their knowledge and experience to develop a cal practice for the diagnosis and care of hypothyroidism. series of specific recommendations and the rationale for A serum thyrotropin is the single best screening test for primary thyroid dysfunction for the vast majority of outpa- tient clinical situations. The standard treatment is replace- ment with L-thyroxine. The decision to treat subclinical hypothyroidism when the serum thyrotropin is less than 10 mIU/L should be tailored to the individual patient. By mutual agreement among the authors and the editors of their respec- INTRODUCTION tive journals, this work is being published jointly in Thyroid and Endocrine Practice. These updated clinical practice guidelines (CPGs) (1–3) *Jeffrey R. Garber, MD, is Chair of the American Association of Clinical Endocrinologists and American Thyroid Association Taskforce on summarize the recommendations of the authors, acting as Hypothyroidism in Adults. All authors after the first author are listed in a joint American Association of Clinical Endocrinologists alphabetical order. (AACE) and American Thyroid Association (ATA) task From the 1Endocrine Division, Harvard Vanguard Medical Associates, Boston, Massachusetts, 2Division of Endocrinology, Beth Israel Deaconess force for the diagnostic evaluation and treatment strategies Medical Center, Boston, Massachusetts, 3New Jersey Endocrine and Diabetes for adults with hypothyroidism, as mandated by the Board Associates, Ridgewood, New Jersey, 4Division of Endocrinology, Mayo of Directors of AACE and the ATA. Clinic, Rochester, Minnesota, 5The Thyroid Unit, North Shore University Hospital, Manhassett, New York, 6Division of Endocrinology, Mount Sinai The ATA develops CPGs to provide guidance and rec- Hospital, New York, New York, 7Division of Endocrinology, ProHealth Care ommendations for particular practice areas concerning thy- Associates, Lake Success, New York, 8Keck School of Medicine, University of roid disease, including thyroid cancer. The guidelines are Southern California, Los Angeles, California, and the 9UCSF Medical Center at Mount Zion, San Francisco, California. not inclusive of all proper approaches or methods, or exclu- Address correspondence to Dr. Jeffrey R. Garber, Endocrinology Division, sive of others. the guidelines do not establish a standard of Harvard Vanguard Medical Associates, 133 Brookline Avenue, Boston MA, care, and specific outcomes are not guaranteed. Treatment 02215. E-mail: [email protected] To purchase reprints of this article, please visit: www.aace.com/reprints. decisions must be made based on the independent judg- Copyright © 2012 AACE. ment of health care providers and each patient’s individual 990 circumstances. A guideline is not intended to take the place was based on specific section titles, thereby avoiding of physician judgment in diagnosing and treatment of par- inclusion of unnecessary detail and exclusion of important ticular patients (for detailed information regarding ATA studies. Compilation of the bibliography was a continual guidelines, see the Supplementary Data, available online at and dynamic process. Once the principal clinical aspects www.liebertpub.com/thy). of hypothyroidism were defined, questions were formu- The AACE Medical Guidelines for Clinical Practice lated with the intent to then develop recommendations that are systematically developed statements to assist health addressed these questions. The grading of recommenda- care professionals in medical decision making for specific tions was based on consensus among the authors. clinical conditions. Most of their content is based on lit- The final document was approved by the American erature reviews. In areas of uncertainty, professional judg- Association of Clinical Endocrinologists (AACE) ment is applied (for detailed information regarding AACE and American Thyroid Association (ATA), and was guidelines, see the Supplementary Data). officially endorsed by the American Association of These guidelines are a document that reflects the cur- Diabetes Educators (AADE), American Academy of rent state of the field and are intended to provide a work- Otolaryngology—Head and Neck Surgery (AAO- ing document for guideline updates since rapid changes in HNS), American College of Endocrinology (ACE), this field are expected in the future. We encourage medi- Italian Association of Clinical Endocrinologists (AME), cal professionals to use this information in conjunction American Society for Metabolic & Bariatric Surgery with their best clinical judgment. The presented recom- (ASMBS), The Endocrine Society of Australia (ESA), mendations may not be appropriate in all situations. Any International Association of Endocrine Surgeons (IAES), decision by practitioners to apply these guidelines must Latin American Thyroid Society (LATS), and Ukranian be made in light of local resources and individual patient Association of Endocrine Surgeons (UAES). circumstances. The guidelines presented here principally address the Objectives management of ambulatory patients with biochemically The purpose of these guidelines is to present an confirmed primary hypothyroidism whose thyroid status updated evidence-based framework for the diagnosis, has been stable for at least several weeks. They do not deal treatment, and follow-up of patients with hypothyroidism. with myxedema coma. The interested reader is directed to the other sources for this information (4). The organization Guidelines for CPGs of the guidelines is presented in Table 1. Current guidelines for CPGs in clinical medicine Serum thyrotropin (TSH) is the single best screening emphasize an evidence-based approach rather than simply test for primary thyroid dysfunction for the vast major- expert opinion (6). Even though a purely evidence-based ity of outpatient clinical situations, but it is not sufficient approach is not applicable to all actual clinical scenarios, for assessing hospitalized patients or when central hypo- we have incorporated this into these CPGs to provide thyroidism is either present or