November 19, 2014
Michael L. LeFevre, M.D., M.S.P.H.
Chair, U.S. Preventive Services Task Force
USPSTF Program Office
540 Gaither Road
Rockville, MD 20850
Dear Dr. LeFevre,
On behalf of the Obesity Care Continuum (OCC), we appreciate the opportunity to provide public comment regarding the United States Preventive Services Task Force (USPSTF) Draft Research Plan: Screening for Obesity and Interventions for Weight Management in Children and Adolescents. The OCC is pleased that the Task Force will be closely examining the issues surrounding screening and treatment interventions for this population.
Our comments will focus primarily on the sections of the Draft Research Plan surrounding the exclusion criteria and proposed outcomes.
First, we have some suggestions regarding the exclusion criteria listed for the systematic review populations and types of studies.
- The exclusion of studies in populations with eating disorders may warrant reconsideration. Night eating syndrome and binge eating disorder in particular are very common in this age group and respond to treatment, but may or may not fit the DSM 5 criteria for the diagnosis of these conditions. This complicates interpretation; it may be difficult to completely exclude this group in reality, and/or excluding studies conducted specifically in this population may leave a significant portion of the clinically relevant population out of the review.
- The exclusion of Polycystic Ovary Syndrome (PCOS) may also complicate the interpretation of findings, since it is currently unclear if PCOS is the result of, or cause of obesity. Additional clarification would be helpful about this. Since establishing the diagnosis of PCOS in the early adolescent female is difficult, a majority of adolescents affected by obesity may have PCOS secondary to obesity.
- The exclusion of hypothyroid conditions may also be problematic. We recommend this be explicitly defined, since thyroid stimulating hormone (TSH) levels can be elevated due to obesity itself.
- Excluding studies with active comparators such as self-help books or standard scripts may also be a disadvantage, since it is important to have objective data comparing one-size-fits all approaches to intensive behavioral therapy. If these studies could be included as a secondary/separate analysis or question, that may be very valuable.
- The exclusion of those with learning or psychiatric disorders also may be problematic. Because intellectual disabilities and comorbid psychiatric disorders are common in this age group, and often medications used to treat them cause weight gain, this would leave the results not applicable to a potentially large part of the clinical population. Also, it is somewhat contradictory since treating children with obesity with significant conditions such as obesity in children with Trisomy 21 or Turner's syndrome is more complex, yet these patients seem to be included in the study group(s).
We also have several comments regarding the proposed outcomes.
- Eating disorders being an adverse outcome may require some methodological clarification/consideration. Although we agree it is important, it may not be clear if this adverse event is because treating obesity can promote eating disorder, or is it that more eating disorders are finally being diagnosed when patients receive assessment and management of obesity.
- It’s not clear if the inclusion of "Disability" as an outcome is appropriate for children/adolescents due to the lack of a normal spectrum. Some additional clarification/consideration may be warranted.
- We would suggest that primary outcomes include CVD and diabetes risk indicators instead of these being intermediate outcomes, and that mental health outcomes also be considered as primary outcomes.
- Finally, we question the use of “reduced pain” as an outcome and believe that there needs to be specificity as to “reduced pain of what?”
Proposed research approach considerations:
First, we question the use of waist circumference as a reliable indicator for children as we are unaware of any standards set for this population. Similarly, we are concerned over the reference to “ideal body weight” under the interventions section. We are not familiar with an accurate method for assessing ideal body weight in growing children. Finally, Identification of adverse events may not be optimally accomplished if a comparator group is required, as a large sample size is required to identify less common complications of an intervention. A comparator group is useful but perhaps difficult to match or otherwise apply in this situation.
Again, we appreciate the USPSTF’s efforts on obesity screening, prevention and treatment. Should you have any questions, or need additional information, please contact me at [email protected] or via telephone at 571-235-6475. Thank you.
Obesity Care Continuum
About the Obesity Care Continuum
The leading obesity advocate groups founded the Obesity Care Continuum or “OCC” in 2010 to better influence the healthcare reform debate and its impact on those affected by overweight and obesity. Currently, the OCC is composed of the Obesity Action Coalition (OAC), the Obesity Society (TOS), the Academy of Nutrition and Dietetics (AND), the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American Society of Bariatric Physicians (ASBP). With a combined membership of more than 125,000 patient and healthcare professional advocates, the OCC covers the full scope from nutrition, exercise and weight management through pharmacotherapy to device and surgery.