Submitted January 13, 2016

Transcription

1 Comments from the American Cancer Society and the American Cancer Society Cancer Action Network on the U.S. Preventive Services Task Force Draft Research Plan for Weight Loss to Prevent Obesity-Related Morbidity and Mortality Submitted January 13, 2016 The comments are being submitted on behalf of the American Cancer Society (the Society) and the American Cancer Society Cancer Action Network (ACS CAN). The Society is the nation s largest voluntary health organization, dedicated to eliminating cancer as a major health outcome through research, education, and service. ACS CAN is the non-profit, non-partisan advocacy affiliate of the Society. ACS CAN advocates for legislative, regulatory, and policy solutions that will make cancer a national priority. Excess body weight is an established cause of many cancers and contributes to cancer recurrence, as well as decreased risk of survival for many cancers. 1 Indeed, systematic literature reviews conducted as part of the World Cancer Research Fund Continuous Update Project have found the evidence convincing that body fatness causes cancers of the esophagus (adenocarcinoma), pancreas, liver, colorectum, postmenopausal breast, endometrium and kidney. Moreover, they find substantial evidence for a probable increased risk for cancers of the gall bladder, ovary and advance prostate. 2 As such, the Society and ACS CAN supports evidence-based interventions that facilitate adults achieving and maintaining a healthy weight in order to reduce their long-term cancer risk. We appreciate the opportunity to provide comments to the U.S. Preventive Services Task Force (Task Force) on the Draft Research Plan for Weight Loss to Prevent Obesity-Related Morbidity and Mortality. Proposed Analytic Framework We generally agree with the proposed analytic framework as appropriate for this research plan. We advise the Task Force to separate behavioral interventions from 1 1 Kushi LH, Doyle C, McCullough M, et al, and the American Cancer Society 2010 Nutrition and Physical Activity Guidelines Advisory Committee. American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Prevention. CA Cancer J Clin 2012; 62: World Cancer Research Fund International. Continuous Update Project.

2 pharmacotherapy interventions in the analytic framework, as indicated in the proposed research approach under interventions. Proposed Key Questions 1. Do primary care relevant behavioral or pharmacotherapy interventions for weight loss and weight loss maintenance lead to improved health outcomes in adults who are overweight or obese and candidates for weight loss interventions? 2. Do primary care relevant behavioral or pharmacotherapy interventions for weight loss and weight loss maintenance lead to weight loss, weight loss maintenance, or a reduction in the incidence or prevalence of obesity-related conditions in adults who are overweight or obese and candidates for weight loss interventions? 3. What are the adverse effects of primary care relevant behavioral or pharmacotherapy interventions for weight loss and weight loss maintenance in adults who are overweight or obese and candidates for weight loss interventions? We generally agree with the proposed key questions as appropriate for this research plan. We agree the primary questions are related to weight loss and weight loss maintenance for adults with an above normal BMI or other weightrelated measure. We encourage the Task Force to consider a key question related to the prevention of weight gain, which we note is excluded in the proposed research approach under study aims. Proposed Contextual Questions 1. Does the predictive value of the body mass index (BMI) for future mortality and health risks differ by population subgroup (i.e., specific racial/ethnic subgroups, older adults)? 2. Does primary care feasible assessment of central adiposity increase the predictive value of BMI for future mortality and health risks? 3. What health effects (i.e., mortality or incidence of cardiovascular disease, type 2 diabetes mellitus, or cancer) are associated with intentional weight loss and/or BMI reduction? We generally agree with the proposed key questions as appropriate for this research plan. We support the proposal to examine central adiposity as another weight-related measure. Additionally, we support the proposal to specifically examine the impact of weight loss on cancer incidence and mortality. We recommend, however, that contextual question three is better aligned with key question one in order to ensure the outcomes included are appropriate for the population and reasonable for the time period assessed.

3 Proposed Research Approach We offer the following comments on the components of the research approach. Study Aims Study aim Weight loss or weight loss maintenance Primary prevention of overweight or obesity Treatment of cardiovascular disease Diabetes management* Treatment of cancer We agree with the proposed inclusion criteria to include both weight loss and weight loss maintenance. However, we recommend primary prevention of overweight and obesity as inclusion criteria, as stated earlier. Preventing overweight and obesity is a better health outcome than treating it, and obesity prevention could include weight maintenance. Populations Populations Adults age 18 years who are candidates for weight loss or weight loss maintenance interventions selected based on an above normal BMI (e.g., 25 kg/m 2 ) or other weightrelated measure (e.g., waist circumference) Patients may or may not have additional risk factors, including hypertension, dyslipidemia, or impaired glucose tolerance/fasting glucose (i.e., prediabetes) Studies limited to: Populations not selected based on weight-related measures Adults with secondary causes of obesity, such as steroid use Adults with chronic diseases in which weight loss/maintenance is part of disease management (e.g., osteoarthritis, known cardiovascular disease, diabetes mellitus, polycystic ovary syndrome, sleep apnea) Adults with known chronic diseases that are not generalizable to the primary care population (e.g., eating disorder, cancer, chronic kidney disease, severe mental illness, cognitive impairment) Children and adolescents Parents (if intended behavior change is directed toward children) Pregnant or postpartum women Adults who are institutionalized

4 We support the proposal to include individuals with BMI>25 kg/m2 or other weight-related measures, as this will include both adults who are overweight or obese. This is an improvement to the current recommendation to screen for excess body weight and initiate interventions at BMI>30 kg/m2, when the individual is already obese. We are concerned about the exclusion of adults with chronic diseases. The focus on adults without chronic disease would exclude a large segment of the U.S. population, many of whom would benefit from interventions for weight loss or weight loss maintenance. This exclusion would also limit this preventive service related to weight loss and management to a younger population who may not yet have developed chronic diseases. Particularly, we are concerned that this exclusion would include cancer patients and survivors. Many cancer survivors return to primary care following their treatment and could benefit from interventions for weight loss or weight loss maintenance interventions for their overall health and to prevent recurrence or a new primary cancer. Settings Settings Studies conducted in or recruited from primary care or a health care system or could feasibly be implemented in or referred from primary care In order for an intervention to be feasible for primary care referral, it would need to be conducted as part of a health care setting or be widely available in the community at a national level (e.g., commercial weight loss programs, technology interventions) Studies conducted in or recruited from settings not generalizable to primary care (e.g., worksites, university classrooms, institutional settings), in a population with pre-existing social ties (e.g., from the same worksite or church), or in a setting where the intervention could not be reproduced in primary care or within a broader health system We generally agree with the settings identified, as they are generally what are reviewed by the Task Force. We support the consideration of primary care referrals to other settings for the interventions. To that point, we encourage the Task Force to clarify that the intervention can be outside of the primary care setting as long as it was referred by primary care and is generalizable. These outside settings may include some that are currently listed in the exclusion criteria.

5 Interventions Interventions Interventions focusing on weight loss or weight loss maintenance, including the following: Behavioral counseling intervention alone or as part of a larger multicomponent intervention on healthful diet and nutrition, physical activity, sedentary behavior, or a combination, including but not limited to: assessment with feedback, advice, collaborative goal-setting, assistance, exercise prescriptions (referral to exercise facility or program), arranging further contacts, or provider training Pharmacologic interventions that are approved by the U.S. Food and Drug Administration as first-line, long-term weight loss or weight management medications: o Orlistat o Lorcaserin hydrochloride o Phentermine-topiramate extended release o Naltrexone hydrochloride and bupropion hydrochloride o Liraglutuide Combination of these interventions Interventions may be delivered via faceto-face contact, telephone, print materials, or technology (e.g., computer-based, text messages) and by a number of potential interventionists, including but not limited to: physicians, nurses, exercise specialists, dietitians, nutritionists, and behavioral health specialists Surgical procedures (laparoscopic adjustable gastric banding, Roux-en-Y gastric bypass, biliopancreatic diversion with duodenal switch, sleeve gastrectomy) Nonsurgical devices and procedures (balloon system, vagus nerve stimulation) Medications that are not approved by the U.S. Food and Drug Administration as longterm weight loss agents, including new agents currently under evaluation (e.g., leptin, peptide YY, oxyntomodulin, melanocortin-4 receptor agonists), agents taken off the market (e.g., fenfluramine, dexfenfluramine, sibutramine), and agents only approved for short-term weight loss (e.g., diethylpropion, phentermine, benzphetamine, phendimetrazine) Medications that are only indicated for the treatment of type 2 diabetes (e.g., metformin, pramlintide, empagliflozin, albiglutide, dulaglutide, alogliptin, exenatide) Complementary and alternative treatments (e.g., acupuncture, mindfulness) Dietary supplements intended for weight loss (e.g., chitosan, guar gum, chromium, ginseng, glucomannan, green tea, hydroxycitric acid, L-carnitine, psyllium, pyruvate supplements, St. John s wort, and conjugated linoleic acid) Health care system interventions Broader community-based programs (e.g., mass media, social marketing, changes to the community built environment, legislation)

6 We strongly support the proposal to include studies examining many different delivery methods and types of providers for the interventions. Many of these providers are not included as part of the current recommendation and their inclusion in an updated recommendation can improve patient access to these providers by potentially requiring reimbursement for their services. We also encourage the Task Force to review which health care professional groups (or types of health professionals) are most effective at interventions for weight loss and weight loss maintenance. We encourage the Task Force to consider inclusion of randomized studies of complementary and alternative treatments (e.g., acupuncture, mindfulness), proposed to be excluded. The public has an interest in these approaches and should be informed of their effectiveness if the data are available. Additionally, the Task Force can conclude that further research is warranted. Finally, we encourage the Task Force to consider inclusion of surgical procedures and non-surgical devices and procedures, currently proposed to be excluded. Surgical procedures and non-surgical devices might be effective for certain adults for weight loss or weight loss maintenance. Outcomes Outcomes KQ 1: Health outcomes: KQ 1: Mortality Morbidity (e.g., diabetic amputation, hypertensive nephrosclerosis) Depression Emotional functioning, as measured by mental subscales of quality of life instruments Physical functioning, as measured by physical subscales of quality of life measures Disability measures (global measures only, such as activities of daily living) Functioning (except as enumerated under health outcomes) Cost-effectiveness Behavioral changes (e.g., physical activity, diet, smoking) KQ 2: Cardiometabolic measures (e.g., glucose levels, blood pressure, lipid levels) KQ 2: Weight outcomes (required for study to be included) and incidence or prevalence of related conditions: Measured weight (e.g., kilograms, pounds) Relative weight (e.g., BMI, % overweight, % obese)

7 Outcomes Total adiposity (e.g., dual-energy x-ray absorptiometry, underwater weighing) Central adiposity (e.g., waist circumference, waist-to-hip circumference ratio) Weight maintenance Incidence or prevalence of obesity-related conditions (e.g., diabetes mellitus, hypertension, dyslipidemia, cardiovascular disease, sleep apnea) KQ 3: Adverse outcomes Serious treatment-related harms at any time point after an intervention began (i.e., death, medical issue requiring hospitalization or urgent medical treatment, inducement of an eating disorder) Discontinuation of medication due to adverse effects We encourage the Task Force to more clearly define the outcomes for key questions one and two. For example, key question one asks if weight loss interventions lead to improved health outcomes. A reduction in the incidence of an obesity-related condition seems to be a reasonable health outcome and therefore should be included as an outcome of key question one. Additionally, the morbidity outcomes should be more clearly defined to be reasonable for the population being assessed and for the time period they will be assessed in. For example, diabetes is an appropriate outcome, whereas diabetic amputation might not be appropriate; a person would have to have diabetes in order to have a diabetic amputation. Yet noted under populations, the research approach is proposing to exclude adults with diabetes. Timing of Outcome Assessments Timing of outcome assessment KQs 1, 2: 12 months after start of intervention or baseline assessment (if the intervention start cannot be determined) KQs 1, 2: <12 months after baseline KQ 3: No minimum followup We generally agree with the timing of outcome assessments. We would note that outcomes for the interventions for key questions one and two may occur in less than a year, therefore the Task Force may consider shorter follow-up times for those questions. For example, results for weight loss may be experienced in six months.

8 Study Designs Study designs KQs 1, 2: Randomized or controlled clinical trials, including cluster randomized trials KQ 3: KQs 1, 2: Any observational studies, ecological studies, case reports, case series, or other noncomparative reviews or letters to the editor Systematic reviews, including meta-analyses, of randomized or controlled clinical trials or cohort studies Randomized or controlled clinical trials, including cluster randomized trials Large cohort or case-control studies reporting serious adverse effects related to weight loss interventions KQ 3: Ecological studies, case-series, and case reports We generally agree with the study designs proposed. However, we recommend the Task Force include large prospective cohort studies, particularly those with repeated measures of weight over time for key questions one and two, in addition to key question three as indicated, in order to assess any benefits, as well as adverse events, of these weight loss and management. Conclusion In conclusion, we strongly encourage the Task Force to write its recommendation as clearly and comprehensively as possible. Health care providers will be looking to these recommendations to make clinical recommendations and importantly, health insurance payers, will be looking to these recommendations to make coverage decisions, based on the requirements of the Affordable Care Act. For questions or additional information, please contact Katie McMahon, Policy Principal, at the American Cancer Society Cancer Action Network, at or Thank you for your consideration.