November 21, 2018
United States Preventive Services Task Force
5600 Fishers Lane
Mail Stop 06E53A
Rockville, MD 20857
Re: Draft Research Plan for Vitamin D Deficiency in Adults: Screening, March 2021
Dear Sir or Madam:
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the United States Preventive Services Task Force (USPSTF) related to its October 25, 2018 Draft Research Plan for Vitamin D Deficiency in Adults: Screening, March 2021 ("Draft Research Plan"). Representing over 104,000 registered dietitian nutritionists (RDNs), nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals and is committed to a world where all people thrive through the transformative power of food and nutrition. The Academy's members independently provide nutrition care services, including Medical Nutrition Therapy (MNT), to individuals with a wide variety of disease states, chronic conditions, and nutrient deficiencies.
The Academy supports the Draft Research Plan and offers the below comments and questions to clarify and potentially improve the research and recommendation process. We encourage the USPSTF to visit our Evidence Analysis Library (EAL) at https://www.andeal.org/ for use as a reference throughout its systematic review processes. Our projects reviewing and assessing various associations and effects of Vitamin D would be particularly relevant to this research plan and the subsequent evidence review. Please contact us for assistance in using or accessing this valuable and helpful resource.
I. Language Employed
We note that this Draft Research Plan uses the term "screening" in the title without reference to the concept of "treatment," despite the Draft Research Plan asking two key questions about treatment. Given the overly-simplified manner in which some insurers and other entities implement the USPSTF's recommendations into (required) covered services, the lack of a specific reference to "treatment" in the forthcoming recommendation's title may actually result in limited coverage of only the screening element of the USPSTF's recommendation without coverage of treatment for the underlying deficiency. Thus, we urge the USPSTF to clearly state that the Draft Research Plan and subsequent recommendation address both screening and treatment.
II. Key Question 1
For KQ1a. "Does screening for vitamin D deficiency result in improved health outcomes?" There are several factors or steps between screening and health outcomes, such as whether the patients receive intervention or not and the type of intervention they receive after screening may independently affect health outcomes; how would this be controlled to avoid confounding the actual effect of screening on health outcomes?
III. Proposed Contextual Question 2
Given the issues implicated by this question, the Academy encourages the USPSTF to visit our Evidence Analysis Library (EAL) at https://www.andeal.org/ for projects reviewing and assessing various associations and effects of Vitamin D that would be particularly relevant to this research plan and the subsequent evidence review.
IV. Proposed Contextual Question 3
The Academy again respectfully notes the potential relevance of our Evidence Analysis Library to this contextual question and encourages the USPSTF to begin scoping similar questions or topics using this resource.
V. Draft Proposed Research Approach
The Academy seeks clarification of the rationale for a number of the study characteristics and criteria in the "Draft: Proposed Research Approach" section, as they appear either arbitrary or to be at odds with the understanding and clinical practice of many providers.
With regard to the "Intervention" criteria for Key Questions 3 and 4, we note that the only interventions studied will be "treatment with oral or injectable vitamin D2 or D3, with or without calcium" and that food-based intervention is excluded. We question why such a limited intervention criteria were chosen, particularly given the importance of food as the first line of treatment? In addition, we suggest that loss of follow-up may be appropriate as part of the inclusion/exclusion criteria. Finally, given the frequency with which many practitioners recommend their patients take an MVI with vitamin D, we seek to understand the rationale behind excluding MVI with vitamin D, and encourage the USPSTF to share their thinking.
With regard to the "Timing: KQ 1: Outcomes measured at 8 weeks or longer after screening" criterion, we seek clarification on the rationale for using 8 weeks as the baseline. We note that individuals with clinical signs of vitamin D deficiency are excluded, which seems counterintuitive given one purpose of screening is to identify clinical symptoms. Is the rationale that the USPSTF is seeking only to review studies in which the screening will determine the need for treatment and not review studies in which it was patent that treatment was necessary given the manifestation of clinical signs? We encourage clarification of the thinking leading to the exclusion of this population.
The Academy sincerely appreciates the opportunity to offer comments regarding the "Draft Research Plan for Vitamin D Deficiency in Adults: Screening, March 2021." Please contact either Jeanne Blankenship by telephone at 312-899-1730 or by email at email@example.com or Pepin Tuma by telephone at 202-775-8277 ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics