Abstract
20 min readIn 2008, the NHLBI initiated these guidelines by sponsoring rigorous systematic evidence reviews for each topic by expert panels convened to develop critical questions (CQs), interpret the evidence, and craft recommendations. In response to the 2011 report from the Institute of Medicine on the development of trustworthy clinical guidelines (1), the NHLBI Advisory Council recommended that the NHLBI focus specifically on reviewing the highest-quality evidence and partner with other organizations to develop recommendations (2, 3). Accordingly, in June 2013 the NHLBI initiated collaboration with the ACC and AHA to work with other organizations to complete and publish the guidelines noted above and make them available to the widest possible constituency. Recognizing that the expert panels/work groups did not consider evidence beyond 2011 (except as specified in the methodology), the ACC, AHA and collaborating societies plan to begin updating these guidelines starting in 2014. The joint ACC/AHA Task Force on Practice Guidelines (Task Force) appointed a subcommittee to shepherd this transition, communicate the rationale and expectations to the writing panels and partnering organizations, and expeditiously publish the documents. The ACC/AHA and partner organizations recruited a limited number of expert reviewers for fiduciary examination of content, recognizing that each document had undergone extensive peer review by representatives of the NHLBI Advisory Council, key federal agencies, and scientific experts. Each writing panel responded to comments from these reviewers. Clarifications were incorporated where appropriate, but there were no substantive changes because the bulk of the content was undisputed. Although the Task Force led the final development of these prevention guidelines, they differ from other ACC/AHA guidelines. First, as opposed to an extensive compendium of clinical information, these documents are significantly more limited in scope and focus on selected CQs on each topic based on the highest-quality evidence available. Recommendations were derived from randomized trials, meta-analyses, and observational studies evaluated for quality and were not formulated when sufficient evidence was not available. Second, the text accompanying each recommendation is succinct, summarizing the evidence for each question. The Expert Panel Reports (Part 3) include more detailed information about the Evidence Statements (ESs) that serve as the basis for recommendations. Third, the format of the recommendations differs from other ACC/AHA guidelines. Each recommendation has been mapped from the NHLBI grading format to the ACC/AHA Classification of Recommendation/Level of Evidence (COR/LOE) construct (Table 1) and is expressed in both formats. Because of the inherent differences in grading systems and the clinical questions driving the recommendations, alignment between the NHLBI and ACC/AHA formats is in some cases imperfect. Explanations of these variations are noted in the recommendation tables, where applicable. There is high certainty based on evidence that the net benefity is substantial. There is moderate certainty based on evidence that the net benefitis moderate to substantial, or there is high certainty that the net benefit is moderate. There is at least moderate certainty based on evidence that there is a small net benefit. There is at least moderate certainty based on evidence that there is no net benefit or that risks/harms outweigh benefits. Net benefit is unclear. Balance of benefits and harms cannot be determined because of no evidence, insufficient evidence, unclear evidence, or conflicting evidence, but the Work Group thought it was important to provide clinical guidance and make a recommendation. Further research is recommended in this area. Net benefit is unclear. Balance of benefits and harms cannot be determined because of no evidence, insufficient evidence, unclear evidence, or conflicting evidence, and the Work Group thought no recommendation should be made. Further research is recommended in this area. In consultation with NHLBI, the policies adopted by the writing panels to manage relationships of authors with industry and other entities (RWI) are outlined in the methods section of each panel report. These policies were in effect when this effort began in 2008 and throughout the writing process and voting on recommendations, until the process was transferred to ACC/AHA in 2013. In the interest of transparency, the ACC/AHA requested that panel authors resubmit RWI disclosures as of July 2013. Relationships relevant to this guideline are disclosed in Appendix 1 . None of the ACC/AHA expert reviewers had relevant RWI (Appendix 2). See Appendix 3 for a list of abbreviations. Systematic evidence reports and accompanying summary tables were developed by the expert panels and NHLBI. The guideline was reviewed by the ACC/AHA Task Force and approved by the ACC Board of Trustees, the AHA Science Advisory and Coordinating Committee and The Obesity Society. In addition, ACC/AHA sought endorsement from other stakeholders, including professional organizations. It is the hope of the writing panels, stakeholders, professional organizations, NHLBI, and Task Force that the guidelines will garner the widest possible readership for the benefit of patients, providers, and the public health. See Tables 2 and 3 for an explanation of the NHLBI recommendation grading methodology. Meta-analyses of such studies. Highly certain about the estimate of effect. Further research is unlikely to change our confidence in the estimate of effect. Meta-analyses of such studies. Moderately certain about the estimate of effect. Further research may have an impact on our confidence in the estimate of effect and may change the estimate. Meta-analyses of such studies. Low certainty about the estimate of effect. Further research is likely to have an impact on our confidence in the estimate of effect and is likely to change the estimate. More than 78 million adults in the United States were obese in 2009 and 2010 (4). Obesity raises the risk of morbidity from hypertension, dyslipidemia, type 2 diabetes mellitus (diabetes), coronary heart disease (CHD), stroke, gallbladder disease, osteoarthritis, sleep apnea and respiratory problems, and some cancers. Obesity is also associated with increased risk of all-cause and CVD mortality. The biomedical, psychosocial, and economic consequences of obesity have substantial implications for the health and well-being of the U.S. population. According to the 1998 “Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults—The Evidence Report” (5), overweight is defined as a body mass index (BMI) of 25 kg/m2 to 29.9 kg/m2 and obesity as a BMI of >30 kg/m2. Current estimates are that 69% of adults are either overweight or obese, with approximately 35% obese (6). These latest data from the National Health and Nutrition Examination Surveys indicate that for both men and women, obesity estimates for 2009 and 2010 did not differ significantly from estimates for 2003 to 2008 and that increases in the prevalence rates of obesity appear to be slowing down or leveling off (6). Nevertheless, overweight and obesity continue to be highly prevalent, especially in some racial and ethnic minority groups, as well as in those with lower incomes and less education. Overweight and obesity are major contributors to chronic diseases in the United States and present a major public health challenge. Compared with normal-weight individuals, obese patients incur 46% higher inpatient costs, 27% more physician visits and outpatient costs, and 80% higher spending on prescription drugs (7). The medical care costs of obesity in the United States are staggering. In 2008 dollars, these costs totaled about $147 billion (7). The Expert Panel was first convened in September 2008 by the NHLBI in cooperation with the National Institute of Diabetes and Digestive and Kidney Diseases to update the 1998 Clinical Guidelines Report (5). The Expert Panel considered new evidence related to key issues on overweight and obesity evaluation and treatment, particularly in individuals with other risk factors for CVD and diabetes. The key issues identified included the appropriateness of the current BMI and waist circumference cutpoints that are used for determining risk in overweight and obese adults across diverse populations; the impact of weight loss on risk factors for CVD and type 2 diabetes, as well as CVD morbidity and mortality; optimal behavioral, dietary intervention and other lifestyle treatment approaches for weight loss and weight loss maintenance; and benefits and risks of various bariatric surgical procedures. The Expert Panel's ultimate goal was to systematically develop ESs and recommendations for 5 CQs to assist clinicians in primary care. The recommendations are based on evidence from a rigorous systematic review and synthesis of recently published medical literature. This guideline is based on the Expert Panel Report (Part 3). The Expert Panel Report contains background and additional material related to content, methodology, evidence synthesis, rationale, and references and is supported by the NHLBI Systematic Evidence Review, which can be found at http://www.nhlbi.nih.gov/guidelines/obesity/ser/. Refer to the “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults,” “2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk,” and “2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk” (8-10) for topics outside the scope of the 2013 AHA/ACC/TOS Obesity Guideline. The NHLBI, in cooperation with the National Institute of Diabetes and Digestive and Kidney Diseases, released the 1998 “Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults—The Evidence Report” (11) as a systematic review of the published scientific literature found in MEDLINE from January 1980 to September 1997 on important topics reviewed by the Expert Panel. The published literature was evaluated to determine appropriate treatment strategies that would constitute evidence-based clinical guidelines on overweight and obesity. The San Antonio Cochrane Center assisted in literature abstraction and in organizing the data into evidence tables, and a methodology consultant worked with the Expert Panel to develop ESs and recommendations. In 2005, the NHLBI initiated the process to update the overweight/obesity guidelines and convened stakeholder groups to provide input on what should be the next-generation guideline development process. The resulting recommendations were used to design the process. To continually improve the quality and impact of the guidelines, the process was updated to assure rigor and minimize bias through the use of strict, evidence-based methodologies to guide the development of ESs and recommendations based on a systematic review of the biomedical literature for a specific period of time. The Expert Panel began its deliberations by developing 23 possible CQs, and after considerable discussion, narrowed the possibilities to 5 targeted CQs. Questions were chosen to aid primary care practitioners (PCPs) and providers who frequently work with obese patients to identify patients at health risk of weight-related comorbidities and to update them on the benefits and risks of weight loss achieved by various approaches. Examples of CQs that were not included for this review included consideration of genetics of obesity, binge-eating disorders, pharmacotherapy, and cost-effectiveness of interventions to manage obesity. For each of the chosen CQs, Expert Panel members reviewed the final list of included and excluded articles, along with the quality ratings, and had the opportunity to raise questions and appeal the ratings to the methodology team. The team then reexamined these articles and presented their rationale for either keeping or changing the quality rating of the articles. Expert Panel members also played a key role in examining the evidence tables and summary tables to be certain the data from each article were accurately displayed. CQ1 and CQ2 were chosen to help providers determine the appropriate criteria to guide a weight loss recommendation. CQ1 addresses the expected health benefits of weight loss as a function of the amount and duration of weight loss. CQ2 addresses the health risks of overweight and obesity and seeks to determine if the current waist circumference cutpoints and the widely accepted BMI cutpoints defining persons as overweight (BMI 25-29.9 kg/m2) and obese (BMI >30 kg/m2) are appropriate for population subgroups. Because patients are interested in popular diets that are promoted for weight loss and see the PCP as an authoritative source of information, CQ3 asks which dietary intervention strategies are effective for weight loss efforts. CQ4 seeks to determine the efficacy and effectiveness of a comprehensive lifestyle approach (diet, physical activity, and behavior therapy) to achieve and maintain weight loss. CQ5 seeks to determine the efficacy and safety of bariatric surgical procedures, including benefits and risks. CQ5 also seeks to determine patient and procedural factors that may help guide decisions to enhance the likelihood of maximum benefit from surgery for obesity and related conditions. In 2007, the NHLBI sought nominations for panel membership that would ensure adequate representation of key specialties and appropriate expertise. The NHLBI staff reviewed the nominees and selected potential chairs and co-chairs for the panels. A Guidelines Executive Committee was formed, consisting of the chairs from each of the 3 panels (obesity, high blood pressure [BP], and high blood cholesterol) and 3 cross-cutting working groups (lifestyle, risk assessment, and implementation). This committee worked with the NHLBI to select panel members from the list of nominees. The Obesity Expert Panel comprised 15 members and 3 ex-officio members, including individuals with specific expertise in psychology, nutrition, physical activity,bariatric surgery, epidemiology, internal medicine, and other clinical specialties. The full Obesity Expert Panel met 23 times throughout the years (5 times face-to-face and 18 times via Webinar). Expert Panel chairs asked all members to disclose any conflicts of interest to the full Expert Panel in advance of the deliberations; members with conflicts were asked to recuse themselves from voting on any aspect of the guideline for which a conflict might exist. Each of the 5 CQs had working groups consisting of a leader and various Expert Panel members who met via conference calls to discuss all aspects of the CQ; to review the list of included and excluded articles along with the quality ratings; to review the evidence tables and summary tables; and to develop spreadsheets, ESs, resulting recommendations, and research/evidence gaps. Expert Panel members had the opportunity to raise questions about the included and excluded articles, submit additional articles that were not identified in the original search,appealthequalityratings on articles, and question articles that were excluded. Each working group presented their findings to the full Expert Panel for all final decisions on ESs and recommendations, including the strength of the evidence. A formal peer review process was initially completed under the auspices of the NHLBI and included 10 expert reviewers and representatives from multiple federal agencies. This document was also reviewed by 6 expert reviewers nominated by the ACC, AHA, and The Obesity Society after the management ofthe guideline transitioned to the ACC/AHA. The ACC, AHA, and The Obesity Society reviewers' RWI information is published in this document (Appendix 2). This document was approved for publication by the governing bodies ofthe ACC, the AHA, and The Obesity Society and is endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Pharmacists Association, American Society for Nutrition, American Society for Parenteral and Enteral Nutrition, American Society for Preventive Cardiology, American Society of Hypertension, Association of Black Cardiologists, National Lipid Association, Preventive Cardiovascular Nurses Association, The Endocrine Society, and WomenHeart: The National Coalition for Women With Heart Disease. The recommendations in Table 4 serve as a guide for PCPs in making evaluations and treatment decisions for overweight and obese patients. The CQs answered by evidence-based recommendations summarize current literature on the risks of overweight and obesity and the benefits of weight loss. They also summarize knowledge on the best diets for weight loss, the efficacy and effectiveness of comprehensive lifestyle interventions on weight loss and weight loss maintenance, and the benefits and risks of bariatric surgery. This information will help PCPs decide who should be recommended for weight loss and what health improvements can be expected. The Expert Panel did not choose a CQ that dealt with various aspects of pharmacotherapy for a comprehensive evidence assessment, because at the time the CQs were chosen there was only one approved medication (orlistat) for weight loss. However, CQ1 includes some ESs on the efficacy of orlistat because the effect of pharmacotherapy on weight loss was included in its evidence review. The Expert Panel provides a treatment algorithm, Chronic Disease Management Model for Primary Care of Patients With Overweight and Obesity (Figure), to guide PCPs in the evaluation, prevention, and management of excess body weight in their patients. The algorithm incorporates, wherever possible, the recommendations derived from the 5 CQs that yielded ESs and recommendations. However, because the 5 CQs that were considered did not cover the entire scope of evaluation, prevention, and management of overweight/ obesity, the panelists provided advice based on other guidelines and expert opinion to give providers a more comprehensive approach to their patients with weight-related issues. Treatment Algorithm—Chronic Disease Management Model for Primary Care of Patients With Overweight and Obesity* *This algorithm applies to the assessment of overweight and obesity and subsequent decisions based on that assessment. Each step (designated by a box) in this process is reviewed in Section 2.2 and expanded on in subsequent sections. †BMI cutpoint determined by the FDA and listed on the package inserts ofFDA-approved obesity medications. BMI indicates body mass index; CVD, cardiovascular disease; and FDA, U.S. Food and Drug Administration. The algorithm is not intended to supplant initial assessment for cardiovascular risk factors or diseases but rather focuses on the identification of patients with excess body weight and those at risk for obesity-related health problems. Its purpose is to guide weight management decision making. The algorithm incorporates the recommendations from CQ3 and CQ4 that patients who have sufficient health risk from overweight or obesity receive comprehensive lifestyle intervention. These approaches were all found effective under conditions in which multidisciplinary teams of medical, nutrition, and behavioral experts and other highly trained professionals worked intensively with individuals on weight management. This intervention should be foundational to additional weight management efforts, such as medications or bariatric surgery. It also emphasizes a fundamental principle of chronic disease management—that is, the need to complement a committed patient with informed providers to effectively manage a chronic condition like obesity and its associated cardiovascular risk factors. A patient encounter for obesity prevention and management is defined as an interaction with a PCP who assesses a patient's weight status to determine presence of overweight or obesity and need for further assessment and treatment. With the patient wearing light clothing or an examination gown and no shoes, weight and height are measured and the BMI calculated. BMI can be calculated manually (weight in kg/[height in meters]2) or electronically by using the electronic medical record or other resources. The BMI should be documented in the patient medical record. These BMI cutpoints define overweight and class I to III obese individuals and identify adults who may be at increased risk for CVD and other obesity-related conditions. Within these categories, additional personal risk assessment is needed because degree of risk can vary 4 and risk of CVD presence of obesity-related Risk assessment for CVD and diabetes in a with overweight or class I to III obesity includes physical and clinical and including blood and panel A waist circumference is recommended for individuals with BMI kg/m2 to provide additional information on It is to waist circumference in patients with BMI kg/m2 because the waist circumference will likely be and will no additional risk The Expert Panel by expert using the current cutpoints for and for as of increased Because obesity is associated with increased risk of hypertension, dyslipidemia, diabetes, and a of other the should for associated conditions. The Expert Panel by expert that management of cardiovascular risk factors dyslipidemia, or or other obesity-related medical conditions sleep be if they are of weight loss efforts. The Expert Panel by expert that the weight and lifestyle and determine other potential questions about of weight and loss of weight loss dietary physical activity, of obesity, and other medical conditions or medications that may to these questions may provide information about the of or factors for overweight and obesity, including and with weight loss or efforts. This information can help the determine any to the patient's medical that can assist weight management and provide appropriate advice on lifestyle The information may also impact recommendations for treatment. loss treatment is for 1) obese individuals and overweight individuals with of increased cardiovascular risk diabetes, hypertension, dyslipidemia, waist or other obesity-related BMI or BMI 25-29.9 additional patients (BMI kg/m2) should be to weight Patients who are overweight (BMI 25-29.9 kg/m2) who not have of increased cardiovascular risk diabetes, hypertension, dyslipidemia, waist or other obesity-related comorbidities should be to additional weight who are weight (BMI kg/m2) and not have a of overweight or obesity should be on the of weight to the health risks of increased body Overweight additional risk factors or weight with a of overweight or For individuals who are overweight (BMI and who not have of increased cardiovascular risk diabetes, hypertension, dyslipidemia, waist or other obesity-related and for individuals who have a of overweight and are weight with risk factors at patients to frequently their weight and to weight by their if they to more than a patients that in physical will help them weight Overweight or obese individuals who would benefit from weight loss but who are not or to the patient's interest in and for weight loss as in and the patient on the of additional weight to health of patient's interest in or for weight loss any cardiovascular risk factors and obesity-related health conditions should be evaluated and The Expert Panel that the and patient on weight loss is The with the should the patient is and to the to at weight loss comprehensive efforts. The can are to make changes in to be more and to use behavior change strategies such as weight and These are the of a comprehensive lifestyle intervention. The decision to weight loss be in the of may a weight loss may make the effort at weight until a the patient is not to these to the patient on to make lifestyle changes are likely to be and patient weight loss and health and comprehensive lifestyle treatment strategies to achieve these for weight A and weight loss goal is an important first Although weight loss of as as of body weight may to in some cardiovascular risk weight benefits. The Expert Panel as an initial goal the loss of of weight 6 methods for weight loss an through physical activity, or of may be achieved with dietary of for and for The of can be to the patient's and health status diets should be used only in limited in a medical care where medical and a lifestyle intervention can be a for CVD risk diabetes, or other medical conditions is also to a is recommended Recommendations for management of medical conditions weight weight loss treatment is manage risk factors such as hypertension, dyslipidemia, and other obesity-related conditions. This includes the patient's for medication change as weight loss particularly for medications and diabetes medications that can patients for weight loss is recommended should be or for comprehensive lifestyle intervention and lifestyle with a trained or is foundational to weight loss of by medications or bariatric surgery. expert if the weight and lifestyle indicates that the patient has in a comprehensive lifestyle intervention as defined in CQ4 and in it is recommended that or be to such a the of a substantial of patients will sufficient weight to improve health with comprehensive lifestyle treatment This recommendation may be by the of comprehensive lifestyle intervention or by patient such as medical conditions that of more treatment. the patient has been to weight or weight loss with comprehensive lifestyle intervention and or has a BMI >30 kg/m2 or BMI kg/m2 with may be Patients who are appropriate for obesity treatment or bariatric surgery, weight and lifestyle indicate a of to achieve or weight loss and who have in a comprehensive lifestyle may be the to pharmacotherapy at the time of of a lifestyle intervention (BMI >30 kg/m2 or BMI kg/m2 with or to be for evaluation for bariatric surgery (BMI or BMI 5 kg/m2 with The effective behavioral weight loss treatment is an in 6 comprehensive weight loss intervention provided in or group by a trained The of an effective comprehensive lifestyle intervention include 1) prescription of a
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