Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025 A Midcourse Report (2022) / Chapter Skim
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Appendix B: Open Session Agendas and Comments
Appendix B: Open Session Agendas and Comments
Pages 117-152
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Department of Agriculture (USDA) and USDA Responses to the National Academies (September 21, 2021)
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Department of Agriculture Janet de Jesus, Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services 4:00 pm Adjourn Open Session
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change for the systematic review process? Response: To be sent separately.
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Topic Identification9 and the related American Journal of Clinical Nutrition publication.10 Information on how this list was prioritized for the Pregnancy and Birth to 24 Months Project is published in the American Journal of Clinical Nutrition, "The Pregnancy and Birth to 24 Months Project: A Series of Systematic Reviews on Diet and Health."11 a. Which topics were predetermined (e.g., B-24, chronic disease)
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Was it considered from a risk of disease or a disease state? Response: For information on the health status criteria used in the committee's NESR systematic reviews, see Scientific Report | Dietary Guidelines Advisory Committee | Part C
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Screenshots of the web pages are provided in the presentation slides.21,22 The committee chair spoke about this criteria at other meetings, including the third meeting.23,24 Health status is also described in this excerpt from the DGA (page 10) : Health Status of Participants in Studies Included in Nutrition Evi dence Systematic Reviews To ensure that the DGA promotes the health of, and reduces the risk of disease, among all Americans, the evidence base that informs the DGA must comprise studies conducted with people who are representative of the general public and it must examine diet through a health promotion and disease prevention lens.
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Response: Yes, all written comments are available on Regulations.gov. • View written comments provided to USDA and HHS on the pro cess to identify the topics and supporting scientific questions to be examined by the committee.25 • View written comments submitted to the 2020 Dietary Guidelines Advisory Committee (DGAC)
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How were existing systematic reviews updated? Response: See Scientific Report | Dietary Guidelines Advisory Committee | Part C
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A detailed description of the methodology used in developing and implementing literature search strategies for NESR systematic reviews is found in the 2020 committee's Scientific Report | Dietary Guidelines Advisory Committee | Part C Methodology43 | Developing and Implementing the Literature Search Strategy (pages 24–26)
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. 55 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic reviews/dietary-patterns-subcommittee/dietary-patterns-bone-health (accessed December 8, 2021)
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56 (The 2020 update is available here.57) In addition, the following questions, which were answered by the 2015 Dietary Guidelines Advisory Committee using existing reports (and found in Part D, Chapter 6, of the 2015 DGAC Scientific Report,58 were updated or built upon by the 2020 committee, using NESR systematic reviews: 1.
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Response: See Scientific Report | Dietary Guidelines Advisory Committee | Part C Methodology66 | Use and/or Update Existing NESR Systematic Reviews (pages 41–44)
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team and food pattern modeling staff are standing entities that support the committee's work, and in the interim, conduct other projects and continuous quality advancement activities. At the beginning of each cycle, the departments outline a time line.
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Charter for advisory March 2003 June 2008 February October 2018 committee filed with 2013 Congress First public meeting of September October 2008 June 2013 March 2019b DGAC 2003 DGAC initiates original N/A February January 2014 March 2019 systematic review of 2009 evidence DGAC submits report August 2004 June 2010 February June 2020c to the Secretaries of 2015 USDA and HHS DGA is released January 2005 January 2011 January 2016 December through press event 2020 a National Academies' two reports on the DGA development process published in Febru ary and September 2017. b A 34-day federal funding gap (i.e., "government shutdown")
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Additionally, more than 65 federal staff supported the committee's review process and an additional 45 federal staff conducted a peer review of the NESR systematic reviews. Funding and staff are important elements to consider when working within a fixed time line, and with the increasing scope of the 2020 edition to include the birth to 24 months population, these additional resources were key to ensuring a transparent, science-driven process within the 5-year time line.
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For example, initially, the questions on dietary patterns consumed during childhood and adolescence only addressed the outcomes of growth, size, and body composition and bone health; whereas for adults, questions on dietary patterns addressed the outcomes of risk of cardiovascular disease, type 2 diabetes, and certain types of cancer. Following public and federal agency comment, the dietary patterns questions were revised and expanded to address dietary patterns and all health outcomes at each stage of life.
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How were existing systematic reviews updated? Were there changes in the search strategies from the previous DGA update?
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Response: As nutrition science has evolved, so have the approaches for examining scientific evidence. For example, since the 2005 committee, food pattern modeling analysis was included as a method to review evidence, and since the 2010 committee, DGACs have conducted original systematic reviews with support from USDA's NESR (formerly NEL)
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For example, for the past several years, NESR, through their Continuous Quality Advancement initiative, has been exploring when and how to integrate meta-analysis into their systematic reviews. For other methodological approaches, such as systems modeling, integration of new methods involves adequate funding, availability of federal datasets, and discussion among staff at USDA and HHS, including input from standing federal committees, such as the Dietary Guidelines Subcommittee of the Interagency Committee on Human Nutrition Research.
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NESR's CQA work also aligns with and is guided by a recommendation from the 2017 National Academies report, which encouraged the secretary of USDA to ensure all NESR reviews align with best practices by • Enabling ongoing training of the NESR staff, • Enabling engagement with and learning from external groups on the forefront of systematic review methods, • Inviting external systematic review experts to periodically evalu ate the NESR's methods, and • Investing in technological infrastructure. NESR CQA is accomplished by "Interest Groups," which are small, selfdirected teams of NESR staff that are tasked to accomplish a specific timelimited assignment addressing a specific evidence synthesis-related topic.
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1. In systematic reviews on chronic disease health outcomes, did NESR exclude 100 percent of a study population with a chronic disease condition if the goal was prevention of another condition?
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3. A previous presentation stated "NESR initiated continuous quality advancement that included ongoing training and professional devel opment; leveraging the expertise of, and collaborating with, method ologists from other leading systematic review organizations, such as Cochrane and the Agency for Healthcare Research and Quality; and expanding technological infrastructure." Can you tell us when in the 2020 DGA time line the quality advancement was initiated?
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The four steps below outline the process used to develop the DGA: 1. Identify topics and supporting scientific questions for the 2020 Dietary Guidelines Advisory Committee (the Advisory Commit tee)
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In short, establishing a new federal advisory committee is a time-intensive process, and depending on other priorities and activities within the departments, a new committee may not be possible within the desired time frame and department budgets. For the 2020 process, USDA and HHS were not able to establish an additional federal advisory committee and addressed this recommendation to redistribute current functions of the Dietary Guidelines Advisory Committee by using 68 Discretionary advisory committee means any advisory committee that is established under the authority of an agency head or authorized by statute.
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In regards to 1b, federal staff support the review of evidence using three scientific approaches: systematic reviews, data analysis, and food pattern modeling. Federal support staff hold advanced degrees in nutrition, dietetics, statistics, or a related health field, and have extensive training in the respective approach used to review the science.
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Prior to convening the advisory committee, federal staff supported food pattern modeling analyses, documented and refined the process for identifying nutrients of public health concern, and initiated discussions regarding data analyses. The intent of each of these activities was to conduct prework in advance of the advisory committee so the committee could initiate its review at its first meeting.
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Response: For the DGA, NESR (formerly NEL) staff supported the 2020 Dietary Guidelines Advisory Committee to complete systematic reviews, including the risk-of-bias assessment of individual studies.
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The NESR team facilitated all aspects of planning, conducting, and documenting the work necessary for timely execution of the systematic reviews in accordance with NESR methodology. The role of the 2020 Advisory Committee was to develop systematic review protocols, or the plan for how a specific systematic review would be conducted using NESR's methodology.
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Therefore, to ensure that the methods NESR uses to conduct systematic reviews continue to align with best practices, NESR engages in a robust continuous quality advancement effort to evaluate and refine processes. NESR's Continuous Quality Advancement initiative involves enhancing staff knowledge and skills through ongoing training and professional development; leveraging the expertise of, and collaborating with, methodologists from other leading systematic review organizations, such as Cochrane and the Agency for Healthcare Research and Quality; and expanding its technological infrastructure.
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Department of Health and Human Services should enhance food pattern modeling to better reflect the complex interactions involved, the variability in intakes, and the range of possible healthful diets. Response: Similar to each scientific approach, USDA supports ongoing continuous quality advancement efforts for food pattern modeling.
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For the first time, the Advisory Committee, with support from federal staff, developed a protocol with an analytic framework that described the overall scope and approach that would be used to answer a food pattern modeling question and an analytic plan that detailed the data and subsequent analysis to be conducted. Food pattern modeling protocols were posted online for public review and presented and discussed at its meetings.
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The 2020 Advisory Committee explored the need to add or modify the USDA Food Patterns based on its systematic reviews. The Advisory Committee decided to carry forward the three USDA food patterns with demonstrated health benefits and expanded the Healthy U.S.-Style and Healthy Vegetarian Eating Patterns to meet the needs of toddlers from 12 to 23 months.
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USDA and HHS developed the DGA by relying on the scientific advice in the committee's report and consultation with subject-matter experts within federal agencies, as well as comments from these agencies and from the public. Information detailing the step-by-step process to develop the DGA can be found on DietaryGuidelines.gov. Any revisions to previous editions of the DGA must have sufficient scientific justification, and by law, must be based on the preponderance of scientific and medical knowledge current at the time. The DGA includes nearly all of the science-based recommendations of the 2020 Dietary Guidelines Advisory Committee, including new dietary advice for
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Response: For each systematic review question, the NESR team supported the committee's development of a systematic review protocol. The systematic review protocols represented the plan for how a specific systematic review would be conducted and were modeled after the PROSPERO format.
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Once the committee's work was complete, and its Scientific Report and systematic reviews were posted publicly, the stand-alone protocols were removed from www.DietaryGuidelines.gov. To address the specific scenario mentioned in the question, search strategies were developed and peer reviewed by NESR librarians and NESR analysts before they were added to the protocols reviewed by the
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Changes to protocols most frequently occurred to the analytic framework or inclusion/exclusion criteria. In some cases, the literature search was run before the protocol changes were made, but the protocol changes did not require revision of the search strategy.
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