RIVAL: Radial vs. Femoral Access for PCI in Patients With ACS
More than two thirds of U.S. adults are overweight or obese, and the rates of obesity are even greater in some racial/ethnic groups.1 Because obesity increases the risk of a host of diseases, health care providers are encouraged to be familiar with the evaluation and treatment options. The recently released American College of Cardiology (ACC)/American Heart Association (AHA)/The Obesity Society (TOS) Guidelines for the Management of Overweight and Obesity in Adults provide a needed update to the original guidelines.2
Guidelines are developed to translate scientific knowledge into clinical practice with the goal of improving and standardizing the care of patients. Previous guidelines were sometimes difficult to apply to clinical practice. Therefore, good processes for dissemination and implementation of guidelines is crucial. The factors influencing lack of guidelines implementation include lack of peer support, lack of resources to implement guidelines, insufficient staff and time, and patients' comorbidities.3
The 2013 guidelines for the management of overweight and obesity (Obesity 2) provide recommendations to primary care practices with respect to the evaluation and treatment of these patients.4 The guidelines addressed five critical questions (CQ) using a rigorous evaluation of the literature, and, based upon that review, the panel crafted recommendations. The five CQs were as follows: 1) Among overweight and obese adults, does weight loss with lifestyle affect cardiovascular disease (CVD) risk factors, morbidity and mortality?; 2) Are the current cut-point values for overweight, obesity, and waist circumference (WC) associated with elevated cardiovascular disease (CVD)-related risk?; 3) What is the comparative efficacy, effectiveness, health benefits, or harm of different dietary strategies for weight loss and weight maintenance?; 4) What is the efficacy and effectiveness of a comprehensive lifestyle intervention program, and what are the characteristics of these programs that are associated with greater weight loss?; 5) What are the efficacy, predictors of weight loss, and complications of the different bariatric surgical procedures?
The recommendations based on these five CQs that address the five As framework for obesity treatment (assess, advise, agree, assist and arrange) can be summarized into three actions for primary care providers: identify, assess and intervene.
- Identify patients at risk for obesity health-related complications, because these patients can benefit from weight loss. Measurements of height and weight for all patients to calculate their body mass index (BMI) is an easy, quick, and inexpensive initial step to identify these patients. It was recommended that height and weight (BMI) be measured at least yearly. The documentation of BMI in medical records was found to vary between 28-88% over 10 U.S. health plans and health care delivery systems.5 The widespread use of electronic medical records (EMR) can help identify overweight (BMI 25-29.9 kg/m2) and obese (BMI ≥30 kg/m2) patients, track their weight history, and create systems to alert clinicians on their BMI and other obesity associated comorbidities.
The Obesity 2 guidelines recommended that WC be measured for those with a BMI 25-35 kg/m2 because there is excellent evidence for curvilinear increases in metabolic risk with increasing WC. Although there was no clear cut-point for WC risk, Obesity 2 accepted the previous recommendations that WCs of >88 cm in women and >102 cm in men be considered high-risk for cardiometabolic abnormalities (although lower cut-points have been recommended by the International Diabetes Federation for certain ethnic/racial groups). A WC above these levels identifies patients that may require additional testing for metabolic abnormalities and who should be counseled on the potential health benefits of weight loss via lifestyle modification. Patients with BMI ≥35 so often have an elevated WC that it was not recommended it be measured for the purpose of additional risk stratification.
- Assess the need to lose weight and willingness to make lifestyle changes to achieve weight loss. Overweight individuals with one additional risk factor (pre-diabetes, diabetes, hypertension, dyslipidemia, or elevated WC) and all obese individuals should be counseled about the potential benefits of lifestyle intervention with the goal of weight loss. The panel recommended that an initial assessment be made as to whether the patient is willing to engage in the efforts to make the necessary lifestyle changes needed to lose weight. If patients are not ready to consider making these changes, interventions focused on weight loss will likely be futile. If the patient is willing, the interventionist may wish to assess their weight loss expectations so as to set realistic weight loss goals. The available data indicates that an initial weight loss goal of 5-10% over six months is realistic. Even such modest weight loss can result in significant improvements in cardiometabolic risk factors such as lipids, blood pressure, and glucose levels.
Because primary care providers may see a large number of patients each day, with correspondingly little time with each patient, balancing the time needed to address the patient's acute and long-term health needs in one visit is challenging. The incorporation of clinical guidelines into EMR to create individualized guidelines tailored to individual patient's risk factors, and other comorbidities that can affect treatment, increased the prescription of guideline recommended cardioprotective medications in a primary care setting.6 Further research is needed in this area to evaluate the direct short and longer term effect on patient outcomes, program sustainability, and improvement on efficiency of care, before broad implementation.
- Intervene by offering comprehensive lifestyle intervention programs, with or without addition of adjunctive therapies. The panel reviewed weight loss efficacy of a wide variety of calorie-restricted dietary strategies combined with lifestyle intervention and found similar weight loss results at six to12 months with all of the approaches. In addition to the diet, comprehensive lifestyle intervention should include increased physical activity and cognitive behavioral interventions to help with adherence. The best outcomes came from intensive (at least ≥14 sessions in six months) in-person, individual, or group session interventions conducted by trained interventionists (health professionals who adhered to protocols for cognitive behavioral interventions designed for weight management). Because this intervention consistently results in medically significant weight reduction on average (individual results vary), this strategy was recommended prior to using adjuvant therapies. Clinicians are encouraged to offer or refer obese/overweight patients to one of these programs provided they could benefit from weight loss and are willing to attempt lifestyle changes. The Look AHEAD trial and the Diabetes prevention program (DPP) employed these interventions to good effect.7,8
Adjuvant therapies for weight loss include bariatric surgery and weight loss medications. Patients with BMI ≥35 with obesity-related comorbidities or BMI ≥40 who are unable to achieve weight loss goals may be referred for evaluation for bariatric surgery. The panel did not endorse a specific type of bariatric surgery and did not find evidence for or against the use of bariatric surgery for patients with BMI < 35. One of the limitations of the guidelines is that medications not approved by the FDA prior to 2012 were not included in the review. Thus, recently approved or FDA reviewed treatments such as lorcaserin, phentermine-topiramate, bupropion-naltrexone and liraglutide, were not evaluated. Therefore, no specific recommendations on the use of these as adjunctive therapies were made.
We note the following challenges in implementing these guidelines: identifying providers of high-intensity lifestyle interventions close enough to the patient to permit participation; lack of readily available data on weight loss efficacy outcomes and cost-effectiveness analysis of the local lifestyle intervention programs; limited available data on the application and outcomes of these interventions in real world (outside academic institutions), including risks and benefits of bariatric surgery; inconsistent reimbursement for these interventions; limited efficacy evidence of interventions in high risk minority groups. Addressing these limitations should help clinicians help their patients implement lifestyle interventions.
Reporting of weight loss outcomes, dropout rates and adverse events should be an expectation for all lifestyle intervention and bariatric surgery community programs. In this manner programs with the best outcomes can be expected to gain the most use.
Reimbursement for efficacy/effectiveness proven high-intensity lifestyle interventions is essential for broad utilization of the programs. In 2011, The Centers for Medicare and Medicaid Services (CMS) started providing coverage for intensive (six months' duration) behavioral therapy for obesity but only for those interventions consistent with the five As framework and provided in a primary care setting.9 Unfortunately, weight loss interventions in primary care settings have had disappointing results, and Medicare doesn't cover high-intensity interventions conducted outside primary care settings. Most other health plans tend to follow CMS recommendations.
Despite all of the above efforts, some people, including high-risk minority groups will not have access to high-intensity lifestyle interventions. Although there is some evidence that online systems and telecommunications may deliver these interventions with some positive effects, weight loss outcomes are less impressive than with in person interventions, ranging from 5-45% of individuals achieving ≥5% weight loss.10,11 More research is needed in this promising field to evaluate the efficacy of electronically delivered interventions.
In conclusion, the Obesity guidelines provide the framework and step-by-step recommendations for clinicians on the evaluation and treatment of overweight and obese patients. However, collaboration between clinicians, community members, insurance companies, government agencies, other stakeholders, and patients is essential for consistent and universal implementation of the guidelines.
- Ogden CL, Carroll MD, Flegal KM. Prevalence of obesity in the United States. JAMA 2014;312:189-90.
- Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obesity Research 1998;6 Suppl 2:51S-209S.
- Francke AL, Smit MC, de Veer AJ, Mistiaen P. Factors influencing the implementation of clinical guidelines for health care professionals: a systematic meta-review. BMC Medical Informatics and Decision Making 2008;8:38.
- Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol 2014;63: 2985–3023.
- Arterburn DE, Alexander GL, Calvi J, et al. Body mass index measurement and obesity prevalence in ten U.S. health plans. Clin Med Res 2010;8:126-30.
- Bellows J, Patel S, Young SS. Use of IndiGO individualized clinical guidelines in primary care. J Am Me Inform Assoc 2014;21:432-7.
- Ryan DH, Espeland MA, Foster GD, et al. Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes. Control Clin Trials 2003;24:610-28.
- The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care 2002;25:2165-71.
- Jacques L, Jensen TS, Schafer J, McClair S, Chin J. Decision Memo for Intensive Behavioral Therapy for Obesity (CAG-00423N) (CMS website) 2011. Available at: cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx. Accessed 9/22/2014.
- Levine DM, Savarimuthu S, Squires A, Nicholson J, Jay M. Technology-assisted weight loss interventions in primary care: a systematic review. J Gen Intern Med 2014 Aug 19. [Epub ahead of print]
- Harvey-Berino J, West D, Krukowski R, et al. Internet delivered behavioral obesity treatment. Prev Med 2010;51:123-8.
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