Abstract and Introduction
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.
I. Introduction and Rationale
Corpulence is not only a disease itself, but the harbinger of others. Hippocrates
Obesity rates have increased sharply over the past 30 years, creating a global public health crisis.[1,2,3]Global estimates suggest that 500 million adults have obesity worldwide with prevalence rates increasing among children and adolescents.[3,4,5] Data from the National Health and Nutrition Examination Surveys show that roughly 2 of 3 United States (U.S.) adults have overweight or obesity, and 1 of 3 adults has obesity.[1,2,3] The impact of obesity on morbidity, mortality, and health care costs is profound. Obesity and weight-related complications exert a huge burden on patient suffering and social costs.[6,7] Obesity is estimated to add $3,559 annually (adjusted to 2012 dollars) to per-patient medical expenditures as compared to patients who do not have obesity; this includes $1,372 each year for inpatient services, $1,057 for outpatient services, and $1,130 for prescription drugs.
In recent years, exciting advances have occurred in all 3 modalities used to treat obesity: lifestyle intervention, pharmacotherapy, and weight-loss procedures, including bariatric surgery. Clinical trials have established the efficacy of lifestyle and behavioral interventions in obesity; moreover, there are 5 weight-loss medications approved by the U.S. Food and Drug Administration (FDA) for chronic management of obesity.[9,10] Bariatric surgical practices have been developed and refined, together with improvements in pre- and postoperative care standards, resulting in better patient outcomes. The FDA has also recently approved devices involving electrical stimulation and gastric balloons for the treatment of obesity. In addition to enhanced treatment options, the scientific understanding of the pathophysiology of obesity has advanced, and it is now viewed as a complex chronic disease with interacting genetic, environmental, and behavioral determinants that result in serious complications. Adipose tissue itself is an endocrine organ which can become dysfunctional in obesity and contribute to systemic metabolic disease. Weight loss can be used to prevent and treat metabolic disease concomitant with an improvement in adipose tissue functionality. These new therapeutic tools and scientific advances necessitate development of rational medical care models and robust evidenced-based therapeutic approaches, with the intended goal of improving patient well-being and recognizing patients as individuals with unique phenotypes in unique settings.
In 2012, the American Association of Clinical Endocrinologists (AACE) published a position statement designating obesity as a disease and providing the rationale for this designation. Subsequently, AACE was joined by multiple professional organizations in submitting a resolution to the American Medical Association (AMA) to recognize obesity as a disease. In June 2013, following a vote by its House of Delegates, the AMA adopted a policy designating obesity as a chronic disease. These developments have the potential to accelerate scientific study of the multidimensional pathophysiology of obesity and present an impetus to our health care system to provide effective treatment and prevention.
In May of 2014, AACE and the American College of Endocrinology (ACE) sponsored their first Consensus Conference on Obesity (CCO) in Washington, DC, to establish an evidence base that could be used to develop a comprehensive plan to combat obesity. The conference convened a wide array of national stakeholders (the "pillars") with a vested interest in obesity. The concerted participation of these stakeholders was recognized as necessary to support an effective overall action plan, and they included health professional organizations, government regulatory agencies, employers, health care insurers, pharmaceutical industry representatives, research organizations, disease advocacy organizations, and health profession educators.
A key consensus concept that emerged from the CCO was that a more medically meaningful and actionable definition of obesity was needed. It became clear that diagnosis based solely on body mass index (BMI) lacked the information needed for effective interaction and concerted policy regarding obesity among stakeholders and was a barrier to the development of acceptable and rational approaches to medical care. It was agreed that the elements for an improved obesity diagnostic process should include BMI alongside an indication of the degree to which excess adiposity negatively affects an individual patient's health.
In response to this emergent concept from the CCO, the AACE proposed an "Advanced Framework for a New Diagnosis of Obesity." This document features an anthropometric component that is the measure of adiposity (i.e., BMI) and a clinical component that describes the presence and severity of weight-related complications. Given the multiple meanings and perspectives associated with the term "obesity" in our society, there was also discussion that the medical diagnostic term for obesity should be "adiposity-based chronic disease" (ABCD).
The paradigm for obesity care proposed by the National Heart, Lung, and Blood Institute, and FDA-sanctioned prescribing information for the use of obesity medications, largely bases indications for therapeutic modalities on patient BMI (a BMI-centric approach). As part of the AACE Clinical Practice Guidelines (CPG) for Developing a Diabetes Mellitus Comprehensive Care Plan, an algorithm for obesity management was proposed wherein the presence and severity of weight-related complications constitute the primary determinants for treatment modality selection and weight-loss therapy intensity. In this new complications-centric approach, the primary therapeutic endpoint is improvement in adiposity-related complications, not a preset decline in body weight. Thus, the main endpoint of therapy is to measurably improve patient health and quality of life. Other organizations such as the American Heart Association, the American College of Cardiology, The Obesity Society, the Obesity Medical Association, and the Endocrine Society have also developed obesity care guidelines and algorithms incorporating aspects of a complications-centric approach.
This AACE/ACE evidence-based clinical practice guideline (CPG) is structured around a series of a priori, relevant, intuitive, and pragmatic questions that address key and germane aspects of obesity care: screening, diagnosis, clinical evaluation, treatment options, therapy selection, and treatment goals. In aggregate, these questions evaluate obesity as a chronic disease and consequently outline a comprehensive care plan to assist the clinician in caring for patients with obesity. This approach may differ from other CPGs. Specifically, in other CPGs: the scientific evidence is first examined and then questions are formulated only when strong scientific evidence exists (e.g., randomized controlled trials [RCTs]), and/or only certain aspects of management (e.g., pharmacotherapy) are chosen for a focused (but not comprehensive) CPG.
Neither of these approaches addresses the totality, multiplicity, or complexity of issues required to provide effective, comprehensive obesity management applicable to real-world patient care. Moreover, the nuances of obesity care in an obesogenic-built environment, which at times have an overwhelming socioeconomic contextualization, require diligent analysis of the full weight of extant evidence.
To this end, these CPGs address multiple aspects of patient care relevant to any individual patient encounter, assess the available evidence base, and provide specific recommendations. The strength of each recommendation is commensurate with the strength-of-evidence. In this way, these CPGs marshal the best existing evidence to address the key questions and decisions facing clinicians in the real-world practical care of patients with obesity. This methodology is transparent and outlined in multiple AACE/ACE processes for producing guideline protocols.[23–25] Implementing these CPGs should facilitate high-quality care of patients with obesity and provide a rational, scientific approach to management that optimizes outcomes and safety. Thus, these CPGs will be useful for all health care professionals involved in the care of patients with, or at risk for, obesity and adiposity-related complications.
Endocr Pract. 2016;22(7):842-884. © 2016 American Association of Clinical Endocrinologists