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Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
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APPENDIX B-1
OPEN SESSION AGENDAS

Meeting 1 Open Session (Virtual)
August 12, 2021
3:30–4:30 PM ET

3:30 pm Opening Remarks
Kathleen Rasmussen, Committee Chair
3:35 Sponsor Remarks
Eve Stoody, Center for Nutrition Policy and Promotion, Food and Nutrition Service, U.S. Department of Agriculture
4:00 Questions from Committee
Moderated by Kathleen Rasmussen, Committee Chair
4:30 pm Adjourn Open Session

Meeting 4 Open Session (Virtual)
September 3, 2021
2:00–4:00 PM ET

2:00 pm Opening Remarks
Kathleen Rasmussen, Committee Chair
2:15 Questions from Committee
Moderated by Kathleen Rasmussen, Committee Chair
Sponsor Remarks

Eve Stoody, Center for Nutrition Policy and Promotion, Food and Nutrition Service, U.S. Department of Agriculture

Julie E. Obbagy, Center for Nutrition Policy and Promotion, Food and Nutrition Service, U.S. 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

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

APPENDIX B-2
MEETING 4 OPEN SESSION QUESTIONS FOR THE U.S. DEPARTMENT OF AGRICULTURE (USDA) AND USDA RESPONSES TO THE NATIONAL ACADEMIES

The Committee on Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020–2025 has some specific follow-up questions related to the discussion they had with the committee in the first meeting open session held on August 12 that they would like to discuss at the September 3 open session. Below is an outline of questions from the committee for the upcoming open session.

  1. Identify milestones in the Dietary Guidelines for Americans (DGA) process:
    1. What was the initial time line for the DGA process compared to the time line after implementing National Academies report recommendations?
      1. How did the initial plan (with milestones) change with implementation of National Academies 2017 recommendations?
      2. How did the initial plan (with milestones) change for the systematic review process?

Response: To be sent separately. (See Appendix B-3.)

  1. How were the DGA topics selected following the public comment period?

Response: In 2017–2018, the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (HHS) supported a process to identify topics to be examined by the 2020 Dietary Guidelines Advisory Committee (DGAC). See Scientific Report | Dietary Guidelines for Americans Advisory Committee | Part C. Methodology1 | Identifying the Topics and Scientific Questions (pages 2–4) and DietaryGuidelines.gov | Process to Identify the Topics and Questions.2 The original list of questions posted for public comment is attached, and the final list is available here.3

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1 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartC_Methodology_first-print.pdf (accessed December 8, 2021).

2 See https://www.dietaryguidelines.gov/resources/about-process/process-identify-topics-and-questions (accessed December 8, 2021).

3 See https://www.dietaryguidelines.gov/resources/about-process/process-identify-topics-and-questions/topics-and-questions-review-organized (accessed December 8, 2021).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×
  • At the first meeting of the 2020 committee, an overview of the topics and question process was provided.4,5
  • Also, the committee’s charter outlines the operations of the committee, time line, and work.6,7 The committee’s charter is linked here.8

In 2012–2013, when initially exploring including infants and toddlers from birth to 24 months in the DGA, USDA and HHS supported a process to identify potential topics related to this life stage. See NESR | Birth to 24 Month (B-24) 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

  1. Which topics were predetermined (e.g., B-24, chronic disease) and which were identified from the interests of the DGAC members and from the comments received from the public?

Response: To be sent separately. (See Appendix B-3.)

  1. What health outcomes were considered for B-24?

Response: The questions considered related to this life stage are provided in the Scientific Report | Dietary Guidelines Advisory Committee | Part D. Chapter 2–7:

  • Chapter 2: Food, Beverage, and Nutrient Consumption During Pregnancy12

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4 See https://www.dietaryguidelines.gov/day-2-topics-and-scientific-questions-be-examined-committee (accessed December 8, 2021).

5 See https://www.dietaryguidelines.gov/sites/default/files/2019-05/Day2TopicsandScientificQuestions.pdf (accessed December 8, 2021).

6 See https://www.dietaryguidelines.gov/day-1-committee-charter-operations-and-timeline-chair-and-vice-chair-remarks (accessed December 8, 2021).

7 See https://www.dietaryguidelines.gov/sites/default/files/2019-05/Day1CmteCharterOperationsTimeline.pdf (accessed December 8, 2021).

8 See https://www.dietaryguidelines.gov/sites/default/files/2019-03/DietaryGuidelinesAdvisoryCommitteeCharter-10-05-18.pdf (accessed December 8, 2021).

9 See https://nesr.usda.gov/birth-24-month-b-24-topic-identification-sr (accessed December 8, 2021).

10 See https://pubmed.ncbi.nlm.nih.gov/24452234 (accessed December 8, 2021).

11 See https://academic.oup.com/ajcn/article/109/Supplement_1/685S/5456707 (accessed December 8, 2021).

12 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartD_Ch2_Pregnancy_first-print.pdf (accessed December 8, 2021).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×
  • Chapter 3: Food, Beverage, and Nutrient Consumption During Lactation13;
  • Chapter 4: Duration, Frequency, and Volume of Exclusive Human Milk and/or Infant Formula Feeding14
  • Chapter 5: Foods and Beverages Consumed During Infancy and Toddlerhood15
  • Chapter 6: Nutrients from Dietary Supplements During Infancy and Toddlerhood16
  • Chapter 7: USDA Food Patterns for Children Younger than Age 24 Months17

And also available on webpages specific to the Birth to 24 Months and Pregnancy and Lactation Subcommittees:

  • Birth to 24 Months Subcommittee | Nutrition Evidence Systematic Review18
  • Pregnancy and Lactation Subcommittee | Nutrition Evidence Systematic Review19
  1. How was chronic disease approached? 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. Methodology20 | Search for, Screen, and Select Literature—Define Inclusion and Exclusion Criteria—Health Status of Study Participants (pages 22–23).

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13 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartD_Ch3_Lactation_first-print.pdf (accessed December 8, 2021).

14 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartD_Ch4_HumMilkFormula_first-print.pdf (accessed December 8, 2021).

15 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartD_Ch5_ComplemFoods_first-print.pdf (accessed December 8, 2021).

16 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartD_Ch6_SupplementsB24_first-print.pdf (accessed December 8, 2021).

17 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartD_Ch7_PatternsB24_first-print.pdf (accessed December 8, 2021).

18 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/birth-24-months-subcommittee (accessed December 8, 2021).

19 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/pregnancy-and-lactation-subcommittee (accessed December 8, 2021).

20 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartC_Methodology_first-print.pdf (accessed December 8, 2021).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

Additionally, this presentation from the 2020 committee’s chair at their first meeting exemplifies how the committee conducted its work, including how protocols drove the process and the standard NESR inclusion and exclusion criteria. Protocols were made publicly available on the DietaryGuidelines.gov website at the time. 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 Evidence 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.

As outlined in the committee’s systematic review protocols, the committee’s reviews included studies with participants who were healthy and/or who were at risk of a chronic disease, including participants with obesity, as well as studies that enrolled some participants with a disease. Because the DGA is not intended to be a clinical guideline for treating chronic diseases, the committee excluded studies that enrolled only patients with a disease with the intention to treat those individuals. In general, the majority of the reviews conducted to inform the DGA included trials that exclusively enrolled participants with overweight or obesity, or who were at high risk of cardiovascular disease or type 2 diabetes, and observational studies that enrolled participants from a wide range of health and weight status, including those with healthy weight, overweight, or obesity. The reviews included few studies that enrolled only healthy participants.

Thus, the DGA are applicable to the overall U.S. population, including healthy individuals and people at risk of diet-related chronic conditions and diseases, such as cardiovascular disease, type 2 diabetes, and obesity. In addition, people living with a diet-related chronic illness can benefit from a healthy dietary pattern. The DGA can serve as a reference for federal, medical, voluntary, and patient care organizations as they

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21 See https://www.dietaryguidelines.gov/meeting-2-day-1-chair-remarks (accessed December 8, 2021).

22 See https://www.dietaryguidelines.gov/sites/default/files/2019-08/Day1-ChairRemarks508c.pdf (accessed December 8, 2021).

23 See https://www.dietaryguidelines.gov/meeting-3-day-1-introductory-and-chair-remarks (accessed December 8, 2021).

24 See https://www.dietaryguidelines.gov/sites/default/files/2019-12/DGACMtg3Day1-ChairRemarks.pdf (accessed December 8, 2021).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

develop nutrition guidance tailored for people living with a specific medical condition. Health professionals can adapt the DGA to meet the specific needs of their patients with chronic diseases, as part of a multifaceted treatment plan.

  1. Can the committee obtain the public comments submitted about the DGA process?

Response: Yes, all written comments are available on Regulations.gov.

  • View written comments provided to USDA and HHS on the process 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).26 A summary of public comments submitted to the committee is available in the DGAC Scientific Report: Appendix F-2: Public Comments.27
    • Oral comments to the 2020 committee were provided at two meetings: Meeting 2 and Meeting 4.28,29
    • At every meeting of the 2020 committee the public was encouraged to provide written comments to the committee. An example from Meeting 1, where the public was provided an overview of how to get involved.30,31
  • View written comments submitted to USDA and HHS on the DGAC Scientific Report.32
    • The departments also received oral comments on the DGAC Scientific Report.33
  • Finally, before and after the first National Academies study on the process to develop the DGA, the departments held two listening sessions to hear perspectives on the DGA development process.

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25 See https://www.regulations.gov/document/FNS-2018-0005-0001 (accessed December 8, 2021).

26 See https://www.regulations.gov/docket/FNS-2019-0001 (accessed December 8, 2021).

27 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartF_2_PublicComments_first-print.pdf (accessed December 8, 2021).

28 See https://www.dietaryguidelines.gov/meeting-2-day-2-public-comments (accessed December 8, 2021).

29 See https://www.youtube.com/watch?v=RfLrBWXgOiM (accessed December 8, 2021).

30 See https://www.dietaryguidelines.gov/day-1-opportunities-public-engagement-and-closing-remarks-opening-session (accessed December 8, 2021).

31 See https://www.dietaryguidelines.gov/sites/default/files/2019-05/Day1PublicEngagement.pdf (accessed December 8, 2021).

32 See https://www.regulations.gov/docket/FNS-2020-0015 (accessed December 8, 2021).

33 See https://www.dietaryguidelines.gov/public-comments-departments (accessed December 8, 2021).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

    Transcripts from these sessions are available here: February 19, 201634 and November 28, 2017.35

  1. What was the process and methodology for the 2020 systematic reviews?

Response: See Scientific Report | Dietary Guidelines Advisory Committee | Part C. Methodology36 | NESR Systematic Review Process (pages 18–46).

At the first meeting of the 2020 committee, NESR provided a presentation to the committee on its process, which included some high-level responses to the National Academies report.37,38

NESR also provided an overview of its methodology to the 2020 committee’s third meeting.39,40

  1. How were existing systematic reviews updated?

Response: See Scientific Report | Dietary Guidelines Advisory Committee | Part C. Methodology41 |Use and/or Update Existing NESR Systematic Reviews (pages 41–44).

The NESR presentation at the committee’s first meeting (see links above) addresses using and updating existing NESR systematic reviews.

  1. Were there changes in the search strategies from the previous DGA update?

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34 See https://www.dietaryguidelines.gov/sites/default/files/2019-12/ListeningSession-Transcript-2-19-16.pdf (accessed December 8, 2021).

35 See https://www.dietaryguidelines.gov/sites/default/files/2019-12/1128USDA-ListeningSessions.pdf (accessed December 8, 2021).

36 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartC_Methodology_first-print.pdf (accessed December 8, 2021).

37 See https://www.dietaryguidelines.gov/day-1-nutrition-evidence-systematic-review (accessed December 8, 2021).

38 See https://www.dietaryguidelines.gov/sites/default/files/2019-05/Day1NutritionEvidenceSystematicReview.pdf (accessed December 8, 2021).

39 See https://www.dietaryguidelines.gov/meeting-3-day-1-nutrition-evidence-systematic-review-nesr-synthesis-evidence (accessed December 8, 2021).

40 See https://www.dietaryguidelines.gov/sites/default/files/2019-12/DGACMtg3Day1-NESRSynthesisOfTheEvidence.pdf (accessed December 8, 2021).

41 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartC_Methodology_first-print.pdf (accessed December 8, 2021).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

Response: See Scientific Report | Dietary Guidelines Advisory Committee | Part C. Methodology42 | Developing and Implementing the Literature Search Strategy (pages 24–26).

  1. Did search strategies change for all or for a subset of systematic reviews?

Response: Yes, there were updates, or changes, made to the search strategies from previous committee reviews.

For every NESR systematic review, the NESR librarian develops and implements a literature search strategy. The literature search strategy includes selecting and using the appropriate bibliographic databases (e.g., PubMed/MEDLINE, Cochrane, Embase, CINAHL), identifying search terms appropriate for the databases being searched, and employing search refinements, such as search filters. 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).

A unique literature search strategy is designed specifically for each systematic review. Therefore, the NESR librarian developed new literature search strategies for all new systematic reviews conducted by the 2020 committee, using the methods referenced above. For those reviews that the 2020 committee was updating, such as those that were originally conducted by the 2015 committee, NESR’s librarian follows standard practice and reviews and updates the literature search used in the existing review to ensure that the search is still comprehensive, appropriate for the protocol, and accounts for updates that occurred to database-specific search terms. For example, PubMed/Medline updates their MeSh (medical subject headings) terms on an annual basis. Therefore, updates, or changes, to the literature searches implemented for the 2020 committee did occur, but any changes were done to ensure each search remained comprehensive and would identify all potentially relevant articles.

  1. How were the 2015 systematic reviews used in the process?

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42 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartC_Methodology_first-print.pdf (accessed December 8, 2021).

43 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartC_Methodology_first-print.pdf (accessed December 8, 2021).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

Response: The following NESR systematic reviews, conducted by the 2015 Dietary Guidelines Advisory Committee, were updated by the 2020 committee:

  1. What is the relationship between dietary patterns consumed and risk of breast cancer?44 (The 2020 update is available here.45)
  2. What is the relationship between dietary patterns consumed and risk of colorectal cancer?46 (The 2020 update is available here.47)
  3. What is the relationship between dietary patterns consumed and risk of prostate cancer?48 (The 2020 update is available here.49)
  4. What is the relationship between dietary patterns consumed and risk of lung cancer?50 (The 2020 update is available here.51)
  5. What is the relationship between dietary patterns consumed and risk of dementia/cognitive decline/Alzheimer’s disease?52 (The 2020 update is available here.53)
  6. What is the relationship between dietary patterns consumed and bone health?54 (The 2020 update is available here.55)

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44 See https://nesr.usda.gov/what-relationship-between-dietary-patterns-and-risk-breast-cancer#plain-summary (accessed December 8, 2021).

45 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/dietary-patterns-subcommittee/dietary-patterns-cancer (accessed December 8, 2021).

46 See https://nesr.usda.gov/what-relationship-between-dietary-patterns-and-risk-colorectal-cancer#plain-summary (accessed December 8, 2021).

47 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/dietary-patterns-subcommittee/dietary-patterns-cancer (accessed December 8, 2021).

48 See https://nesr.usda.gov/what-relationship-between-dietary-patterns-and-risk-prostate-cancer#plain-summary (accessed December 8, 2021).

49 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/dietary-patterns-subcommittee/dietary-patterns-cancer (accessed December 8, 2021).

50 See https://nesr.usda.gov/what-relationship-between-dietary-patterns-and-risk-lung-cancer#plain-summary (accessed December 8, 2021).

51 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/dietary-patterns-subcommittee/dietary-patterns-cancer (accessed December 8, 2021).

52 See https://nesr.usda.gov/what-relationship-between-dietary-patterns-and-risk-dementiacognitive-declinealzheimers-disease#plain-summary (accessed December 8, 2021).

53 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/dietary-patterns-subcommittee/dietary-patterns-neurocognitive-health (accessed December 8, 2021).

54 See https://nesr.usda.gov/what-relationship-between-dietary-patterns-and-bone-health#plain-summary (accessed December 8, 2021).

55 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/dietary-patterns-subcommittee/dietary-patterns-bone-health (accessed December 8, 2021).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×
  1. What is the relationship between added sugars and risk of cardiovascular disease?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. What is the relationship between the intake of saturated fat and the risk of cardiovascular disease? (The 2020 committee’s question was: What is the relationship between types of dietary fat consumed and risk of cardiovascular disease?)59
  2. What is the relationship between the intake of added sugars and body weight/obesity? (The 2020 committee’s question was: What is the relationship between beverage consumption and growth, size, body composition, and risk of overweight and obesity?)60
  1. Peer-review process for the systematic reviews: Was there a defined methodology for peer reviews? How were the reviewers chosen, and how were the systematic reviews assigned to them; for example, did the reviewers each see all of the systematic reviews or was there some other process? Is the review process published? What were the specifications for the review process?

Response: See Scientific Report | Dietary Guidelines Advisory Committee | Part C. Methodology61 | Peer Review of NESR Systematic Reviews (pages 45–46).

  1. Food modeling process: What was the process used in food modeling? Are there multiple groups of scientists involved? If so, how were

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56 See https://nesr.usda.gov/what-relationship-between-added-sugars-and-risk-cardio-vascular-disease#plain-summary (accessed December 8, 2021).

57 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/beverages-and-added-sugars-subcommittee/added-sugars-cardiovascular-disease (accessed December 8, 2021).

58 See https://www.dietaryguidelines.gov/about-dietary-guidelines/previous-editions/2015-dietary-guidelines (accessed December 8, 2021).

59 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/dietary-fats-and-seafood-subcommittee/dietary-fat-cardiovascular-disease (accessed December 8, 2021).

60 See https://nesr.usda.gov/2020-dietary-guidelines-advisory-committee-systematic-reviews/beverages-and-added-sugars-subcommittee/beverages-growth-size-body-composition-obesity (accessed December 8, 2021).

61 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartC_Methodology_first-print.pdf (accessed December 8, 2021).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

    their contributions used together? What is the plan for food modeling in future editions of the DGA?

Response: See Scientific Report | Dietary Guidelines Advisory Committee | Part C. Methodology62 — See Approaches Used to Answer Questions: Food Pattern Modeling (pages 16–18) with supplementary information at DietaryGuidelines.gov | 2020 Dietary Guidelines Advisory Committee Food Pattern Modeling.63

At the first meeting, the committee was introduced to the food pattern modeling approach.64,65

  1. How do the federal agencies identify when new evidence was needed for a DGA topic?
    1. What tools are used, and what plans are in place for incorporating new evidence into a systematic review?

Response: See Scientific Report | Dietary Guidelines Advisory Committee | Part C. Methodology66 | Use and/or Update Existing NESR Systematic Reviews (pages 41–44).

  1. When do data need to be analyzed in innovative ways to prepare for a DGA review?

Response: To be sent separately. (See Appendix B-3.)

  1. How do the agencies decide that it is time to adopt new methodological approaches to developing the DGA?

Response: To be sent separately. (See Appendix B-3.)

  1. From what has been published to date, it appears that there were barriers to including systems modeling in the most recent edition of the DGA. What were these barriers, and what are your plans, if any, for addressing them?

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62 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartC_Methodology_first-print.pdf (accessed December 8, 2021).

63 See https://www.dietaryguidelines.gov/2020-advisory-committee-report/food-pattern-modeling (accessed December 8, 2021).

64 See https://www.dietaryguidelines.gov/day-1-food-pattern-modeling (accessed December 8, 2021).

65 See https://www.dietaryguidelines.gov/sites/default/files/2019-05/Day%201%20Food%20Pattern%20Modeling.pdf (accessed December 8, 2021).

66 See https://www.dietaryguidelines.gov/sites/default/files/2020-07/PartC_Methodology_first-print.pdf (accessed December 8, 2021).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

Response: To be sent separately. (See Appendix B-3.)

  1. Similarly, what influenced decision making around implementation of a continuous process improvement strategy?

Response: To be sent separately. (See Appendix B-3.)

APPENDIX B-3
MEETING 4 OPEN SESSION QUESTION FOR THE U.S. DEPARTMENT OF AGRICULTURE (USDA) AND USDA RESPONSES TO THE NATIONAL ACADEMIES—2

The Committee on Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020–2025, has some specific follow-up questions related to the discussion they had with USDA in the first meeting open session held on August 12 that they would like to discuss at the September 3 open session. Below is an outline of questions from the committee for the upcoming open session:

  1. Identify milestones in the DGA process:
    1. What was the initial time line for the DGA process compared to the time line after implementing National Academies report recommendations?
      1. How did the initial plan (with milestones) change with implementation of National Academies 2017 recommendations?
      2. How did the initial plan (with milestones) change for the systematic review process?

Response: Each edition of the DGA is released on a 5-year cycle. Throughout this 5-year cycle, USDA and HHS work together to support development and implementation of the current edition and planning for the next edition. Additionally, the Nutrition Evidence Systematic Review (NESR) 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. There are two elements of the time line that are fixed: (1) the DGA must be released at least every 5 years and (2) the committee is convened under a charter not to exceed 2 years. Each cycle, the departments aim to maximize the time the committee has to review the scientific evidence and provide the departments as much time as possible to write and release the DGA.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

USDA and HHS planned the 2020 process, and its time line, after taking into consideration the National Academies recommendations, along with other inputs. As such, there was not an “initial plan” that was changed. However, for comparative purpose, the table below provides dates associated with some of the major milestones of the process used to establish the last four editions of the DGA.

Dates Associated with Major Milestones of the Process Used to Establish the 2005, 2010, 2015, and 2020 Editions of the Dietary Guidelines for Americans

2005 Dietary Guidelines Process 2010 Dietary Guidelines Process 2015 Dietary Guidelines Process 2020 Dietary Guidelines Process
Memorandum of Understanding between USDA and HHS to support development of the next edition October 2002 August 2007 June 2012 December 2017a
Federal Register notice soliciting comments on topics and questions N/A N/A N/A March 2018
Federal Register notice soliciting nominations for Dietary Guidelines Advisory Committee (DGAC) May 2003 April 2008 October 2012 September 2018
Charter for advisory committee filed with Congress March 2003 June 2008 February 2013 October 2018
First public meeting of DGAC September 2003 October 2008 June 2013 March 2019b
DGAC initiates original systematic review of evidence N/A February 2009 January 2014 March 2019
DGAC submits report to the Secretaries of USDA and HHS August 2004 June 2010 February 2015 June 2020c
DGA is released through press event January 2005 January 2011 January 2016 December 2020

a National Academies’ two reports on the DGA development process published in February and September 2017.

b A 34-day federal funding gap (i.e., “government shutdown”) delayed the process to establish the 2020 Dietary Guidelines Advisory Committee.

c The committee’s report release was delayed 1 month because of the COVID-19 pandemic.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

For the 2020 process, there were many factors that affected the timeline. A few of these are outlined below:

  • At the initiation of the process, the National Academies’ reports were released in February and November 2017. Because the Dietary Guidelines Advisory Committee is one of approximately 1,000 federal advisory committees managed under the Federal Advisory Committee Act, the study recommendations required substantial review and discussion across the departments, including with committee management officials and legal and ethics counsel.
  • From December 2018 to January 2019 there was a federal lapse in funding (i.e., a “government shutdown”), which delayed the announcement of the committee.
  • Beginning in March 2020 through the release of the 2020 edition, the COVID-19 pandemic affected the process in several ways, including a delay in the release of the committee’s report.

In addition to time, two other resources are important in the development process: funding and staff. The DGA is an unfunded mandate, and the 2020 edition was the first to receive congressional funding of $12.3 million over 3 years for development and release. 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.

Several of the National Academies recommendations encouraged separation of responsibility, which have time line implications:

  • In some cases, the National Academies recommendations supported work already under way. For example, NESR systematic reviews were under way as part of the Pregnancy and Birth to 24 Months Project and were published as the committee began its work.
  • Additionally, prior to convening the committee, federal staff explored food pattern modeling activities for individuals who are pregnant or lactating, documented and refined the process for identifying nutrients of public health concern, and met to begin discussing data analysis needs.
  • Of note, identifying the topics and questions prior to establishing the committee has potentially the greatest effect on the com
Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

    mittee’s time line. As a comparison, the 2015 committee spent approximately 6 months identifying topics and questions. Having the topics and questions in advance allowed the 2020 committee to initiate its review of evidence upon being established. In the future, USDA and HHS hope to refine this step to continue to support maximizing the time the committee has available to examine the evidence.

  1. How were the DGA topics selected following the public comment period? What health outcomes were considered for B-24? How was chronic disease approached? Was it considered from a risk of disease or a disease state? Can the committee obtain the public comments submitted about the DGA process?

Response: Sent separately (9/1/21). (See Appendix B-2.)

  1. Which topics were predetermined (e.g., B-24, chronic disease) and which were identified from the interests of the DGAC members and from the comments received from the public?

Response: In the previous response to this inquiry (9/1/21), USDA and HHS sent (1) the initial list of topics and questions identified by the departments and posted for public comment and (2) the final list of topics and questions provided to the 2020 committee. Many of the questions identified were examined by previous DGACs or in the Pregnancy and Birth to 24 Months Project and were prioritized for inclusion using the following criteria: relevance, importance, potential effect on federal programs, and avoiding duplication.

Following agency and public comment, the general scope of the topics and questions remained similar. One of the main differences was to expand the life stages addressed in a number of topics and questions that had previously focused on a specific subset of life stages. 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.

Additionally, some health outcomes were added to address outcomes of interest in the public and agency comments. Of note, neurocognitive health and all-cause mortality were outcomes added following the comment period.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

Finally, some questions were added following public and agency comments to address areas of uncertainty. For example, the 2015 committee did not complete reviews on alcoholic beverages and health outcomes, and this was identified as an area requiring updated review. Additionally, the initial list of topics and questions did not include questions on added sugars and health outcomes, but in response to comments, USDA and HHS added questions considered by the 2015 committee on added sugars and risk of overweight/obesity, cardiovascular disease, and type 2 diabetes.

The 2020 committee received the full list of questions identified by USDA and HHS to consider in its review. The committee’s charter stated, “The committee will limit its review and advice to dietary guidance for human nutrition on the topics and scientific questions specified by the departments.” Ultimately, owing to time constraints, the committee prioritized questions from that full list, and did not complete all of the questions posed by the departments. The 2020 committee did not add additional questions beyond those provided by the departments.

  1. What was the process and methodology for the 2020 systematic reviews? How were existing systematic reviews updated? Were there changes in the search strategies from the previous DGA update? Did search strategies change for all or for a subset of systematic reviews? How were the 2015 systematic reviews used in the process?

Response: Sent separately (9/1/21). (See Appendix B-2.)

  1. Peer-review process for the systematic reviews: Was there a defined methodology for peer reviews? How were the reviewers chosen, and how were the systematic reviews assigned to them; for example, did the reviewers each see all of the systematic reviews or was there some other process? Is the review process published? What were the specifications for the review process?

Response: Sent separately (9/1/21). (See Appendix B-2.)

  1. Food modeling process: What was the process used in food modeling? Are there multiple groups of scientists involved? If so, how were their contributions used together? What is the plan for food modeling in future editions of the DGA?

Response: Sent separately (9/1/21). (See Appendix B-2.)

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×
  1. How do the federal agencies identify when new evidence was needed for a DGA topic?

Response: When identifying topics and questions for the 2020 committee, the existence of new evidence was not a formal criterion used in selecting or prioritizing topics for review. However, federal scientists who have expertise in various topic areas are engaged in the topics-and-questions process and provide feedback on the availability of new evidence. Based on input received from the 2020 committee, the 2017 National Academies report, and new techniques used by other systematic review organizations, NESR is currently conducting continuous evidence monitoring and using evidence scans to understand the volume and characteristics of evidence available on a topic or question. This information will be useful in determining when existing reviews should be updated, or when there is enough evidence available on a topic or question to proceed with a review.

  1. What tools are used, and what plans are in place for incorporating new evidence into a systematic review?

Response: Sent separately (9/1/21). (See Appendix B-2.)

  1. When do data need to be analyzed in innovative ways to prepare for a DGA review?

Response: Innovative approaches for examining the evidence are identified in between committee reviews. There are many rationales why new approaches are developed in advance of a committee being in place. First, DGACs are time-limited, discretionary federal advisory committees, and their time is needed to focus on the review of diet and health. Second, resources, research, and staff are needed to develop and refine methodologies. Finally, the DGA are mandated to reflect the preponderance of scientific evidence, and as such, emerging methodologies can be explored but only integrated when they are advanced enough to support the development of national nutrition public health guidance.

  1. How do the agencies decide that it is time to adopt new methodological approaches to developing the DGA?

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).

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

The agencies adopt new methodologies when they are advanced enough to support national nutrition public health guidance. How this decision is made depends on the process. 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.

  1. From what has been published to date, it appears that there were barriers to including systems modeling in the most recent edition of the DGA. What were these barriers, and what are your plans, if any, for addressing them?

Response: In short, the barriers have included time, resources, and the need to develop the methodology for informing guidance on diet and health. As noted previously, the DGA is an unfunded mandate. Funds have been requested but not secured to explore this methodology. The departments plan to continue to request funding to explore this approach.

  1. Similarly, what influenced decision making around implementation of a continuous process improvement strategy?

Response: USDA and HHS have supported the development of the DGA since 1980 and have utilized a Dietary Guidelines Advisory Committee (DGAC) since 1985. Additionally, the fact that the process occurs on a regular 5-year cycle allows the departments to plan ahead, reflect on lessons learned, keep abreast of consensus best practices in guidance development, follow other processes for developing guidance, and maintain staff who have the institutional knowledge to continue to advance the process. As a result of our continuous process improvement strategy, USDA created the NESR (formerly NEL) prior to initiating the 2010 committee. When NESR was launched, its methodology was modeled on that of the Academy of Nutrition and Dietetics’ Evidence Analysis Library.

NESR’s Continuous Quality Advancement (CQA) initiative, which has been ongoing since NESR was launched, is critical for ensuring we remain at the forefront of food- and nutrition-related evidence synthesis, and have the capacity to maintain, and expand, our high-quality, mission-critical work. Our CQA initiative involves the routine evaluation and refinement of our methodology and tools to ensure processes remain

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

state of the art and aligned with other organizations, such as Cochrane, AHRQ, and NIH/NIEHS’s National Toxicology Program, as well as other international organizations that support the development of evidence-based dietary guidance. When appropriate and feasible, refinements to our methodology are carefully planned, tested, and adopted. CQA work results in timely updates to NESR’s methodology, as well as to staff training materials. NESR’s CQA initiative also includes outreach activities designed to disseminate information about us and our work to a range of audiences.

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 evaluate the NESR’s methods, and
  • Investing in technological infrastructure.

NESR CQA is accomplished by “Interest Groups,” which are small, self-directed teams of NESR staff that are tasked to accomplish a specific time-limited assignment addressing a specific evidence synthesis-related topic. These topics are identified and selected based on after-action input from experts and NESR staff following the completion of each NESR review project, monitoring of evolutions occurring in the fields of systematic review and nutrition science, and from other key resources, such as the 2017 National Academies report.

NESR’s CQA model allows our staff to build capacity and expertise in a wide range of topic areas. Interest group work always involves a landscape analysis of other systematic review organizations’ approaches to the topic, followed by a thorough exploration of whether and how these other approaches can be integrated into NESR’s approach, or tailored to meet NESR’s needs. CQA often involves engagement with topic-specific experts from those organizations to discuss, ask questions, and get input on NESR’s approach. Whenever feasible, NESR explores how technology can be used to enhance the efficiency and rigor of its work.

See “Advancing NESR Methodology” on NESR’s website at https://nesr.usda.gov/continuous-quality-advancment.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

APPENDIX B-4
QUESTIONS TO THE U.S. DEPARTMENT OF AGRICULTURE (USDA) AND USDA RESPONSES TO THE NATIONAL ACADEMIES (SEPTEMBER 14, 2021)

  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?

Response: In most cases, yes. One exception is obesity; in reviews that examine chronic disease health outcomes, like cardiovascular disease or type 2 diabetes, NESR did not exclude studies that enrolled 100 percent individuals classified as obese.

This criteria was designed to ensure that the evidence base that informs the DGA was comprised of studies conducted with people who are representative of the general public and must examine diet through a health promotion and disease prevention lens.

As outlined in the committee’s systematic review protocols, the committee’s reviews included studies with participants who were healthy and/or who were at risk of a chronic disease, including participants with obesity, as well as studies that enrolled some participants with a disease. Because the DGA is not intended to be a clinical guideline for treating chronic diseases, the committee excluded studies that enrolled only patients with a disease with the intention to treat those individuals.

In general, the majority of the reviews conducted to inform the DGA included trials that exclusively enrolled participants with overweight or obesity, or who were at high risk of cardiovascular disease or type 2 diabetes, and observational studies that enrolled participants from a wide range of health and weight status, including those with healthy weight, overweight, or obesity. The reviews included few studies that enrolled only healthy participants.

Thus, the DGA are applicable to the overall U.S. population, including healthy individuals and people at risk of diet-related chronic conditions and diseases, such as cardiovascular disease, type 2 diabetes, and obesity. In addition, people living with a diet-related chronic illness can benefit from a healthy dietary pattern. The DGA can serve as a reference for federal, medical, voluntary, and patient care organizations as they develop nutrition guidance tailored for people living with a specific medical condition. Health professionals can adapt the DGA to meet the specific needs of their patients with chronic diseases, as part of a multifaceted treatment plan.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×
  1. How did the DGAC engage in systems science?

Response: See responses sent separately. (See Appendix B-3.)

  1. A previous presentation stated “NESR initiated continuous quality advancement that included 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 technological infrastructure.” Can you tell us when in the 2020 DGA time line the quality advancement was initiated? Was it in the first year, second, etc.?

Response: NESR Continuous Quality Advancement (CQA) activities occur following each major NESR review project and before the next major project is set to begin. For example, NESR’s major CQA efforts have occurred at the following time points:

  • 2010: During/after the 2010 Dietary Guidelines Advisory Committee and before the Dietary Patterns Project
  • 2014: After the Dietary Patterns Project and before the 2015 Dietary Guidelines Advisory Committee
  • 2015: After the 2015 Dietary Guidelines Advisory Committee and before the Pregnancy and Birth to 24 Months Project
  • 2017–2018: After the Pregnancy and Birth to 24 Months Project and before/during the 2020 Dietary Guidelines Advisory Committee

So, in preparation for supporting the 2020 Dietary Guidelines Advisory Committee, NESR initiated CQA activities in 2017–2018, as the Pregnancy and Birth to 24 Months Project was nearing completion.

Topics to be addressed in NESR’s CQA are identified and selected based on after-action input from experts and NESR staff following the completion of the project, monitoring recent evolutions occurring in the fields of systematic review and nutrition science, and from other key resources, such as the 2017 National Academies report.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

APPENDIX B-5
QUESTIONS TO THE U.S. DEPARTMENT OF AGRICULTURE (USDA) AND USDA RESPONSES TO THE NATIONAL ACADEMIES (SEPTEMBER 21, 2021)

Q: How did the process used to create the DGA integrate the seven recommendations from the National Academies’ second report, Redesigning the Process for Establishing the Dietary Guidelines for Americans?

In 2016, Congress appropriated funds to USDA to engage the National Academies of Sciences, Engineering, and Medicine (the National Academies) to conduct a comprehensive study of the process used to establish the DGA. The study culminated in two reports that provided recommendations on how to update the process to develop the DGA.67 In several cases, these recommendations supported or confirmed work USDA and HHS already had under way. This response highlights the National Academies’ recommendations in its second report and how USDA and HHS responded to these recommendations as the departments jointly developed the DGA.

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 Committee) to address in its scientific review;
  2. Select experts to serve on the independent, external Advisory Committee;
  3. Advisory Committee reviews the scientific evidence and develops its scientific report; and
  4. USDA and HHS develop the next edition of the DGA, taking into consideration the Advisory Committee’s scientific report, as well as input from federal agencies and the public.

The National Academies’ second report, Redesigning the Process for Establishing the Dietary Guidelines for Americans, provided recommendations pertaining to steps 3 and 4. Responses from USDA and HHS to the recommendations from the second report are provided below. (Note: National Academies Report 2, recommendation 2, is listed last to allow

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67 NASEM (National Academies of Sciences, Engineering, and Medicine). 2017. Optimizing the process for establishing the Dietary Guidelines for Americans: The selection process. Washington, DC: The National Academies Press. https://doi.org/10.17226/24637. NASEM. 2017. Redesigning the process for establishing the Dietary Guidelines for Americans. Washington, DC: The National Academies Press. https://doi.org/10.17226/24883.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

the responses to follow in chronological order in line with the DGA development process.)

Report 2, recommendation 1: The secretaries of the U.S. Department of Agriculture and the U.S. Department of Health and Human Services should redesign the Dietary Guidelines for Americans (DGA) process to prioritize topics to be reviewed in each DGA cycle, and redistribute the current functions of the Dietary Guidelines Advisory Committee to three separate groups:

  1. A Dietary Guidelines Planning and Continuity Group to monitor and curate evidence generation, to identify and prioritize topics for inclusion in the DGA, and to provide strategic planning support across DGA cycles;
  2. Technical expert panels to provide content and methodological consultation during evaluation of the evidence; and
  3. A Dietary Guidelines Scientific Advisory Committee to interpret the scientific evidence and draw conclusions.

Response: In USDA and HHS’s review of this recommendation, it was determined that carrying out this recommendation as written would require the establishment of two or more discretionary federal advisory committees. Since the 1985 edition of the DGA, a discretionary68 federal advisory committee has been reestablished every 5 years to provide advice to USDA and HHS for their use in developing the next edition of the DGA. At any given time, the federal government maintains approximately 1,000 federal advisory committees. There is an extensive process to request a federal advisory committee, and departments have an annual budget for federal advisory committees. 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

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68Discretionary advisory committee means any advisory committee that is established under the authority of an agency head or authorized by statute. An advisory committee referenced in general (nonspecific) authorizing language or congressional committee report language is discretionary, and its establishment or termination is within the legal discretion of an agency head. Other types of advisory committees include independent Presidential advisory committees, nondiscretionary advisory committees, and Presidential advisory committees. For more information, see FACA Final Rule (102-3.25). See http://www.gsa.gov/portal/mediaId/218007/fileName/FACAFinalRule_R2E-NZ_0Z5RDZ-i34K-pR.action.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

federal nutrition scientists, existing federal committees, and NESR Technical Expert Collaboratives as described below.

In response to recommendation 1a, for the 2020 process, federal scientists and federal nutrition program experts from USDA and HHS identified and prioritized the topics and scientific questions that were examined by the committee. The list of topics and questions was informed by experts from across the federal government including scientists, nutritionists, and program specialists from USDA, HHS, the U.S. Department of Veterans Affairs (VA), and the U.S. Department of Defense (DoD). To finalize the list, public and agency comments were requested and considered based on the predetermined and publicly stated criteria listed online and in the Federal Register notice.

To support ongoing strategic planning, USDA’s Center for Nutrition Policy and Promotion and HHS’s Office of Disease Prevention and Health Promotion have staff who continuously support the DGA process and plan for future editions. These staff work with other federal nutrition scientists in standing committees, including the Interagency Committee on Human Nutrition Research Subcommittee on Dietary Guidance and the Dietary Guidance Review Committee.

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.

In response to growing interest in the inclusion of infants and toddlers69 into the DGA, beginning in 2012, USDA and HHS undertook a series of projects to identify topics and scientific questions and conduct systematic reviews related to diet and health for individuals who are pregnant and for infants and toddlers. The P/B-24 Project was completed in 2018 and involved the conduct of a series of systematic reviews on diet and health for women who are pregnant and for infants and toddlers. This project was led jointly by USDA and HHS. USDA’s Nutrition Evidence Systematic Review (NESR) team conducted systematic reviews for the P/B-24 Project with the support of Technical Expert Collaboratives. A federal expert group, a broadly representative group of federal researchers and program leaders, also provided input throughout the P/B-24 Project. The 2020 committee was able to use a number of these existing systematic reviews to answer the scientific questions they were tasked with addressing.

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69 Raiten, D.J., R. Raghavan, A. Porter, J.E. Obbagy, and J.S. Spahn. 2014. Executive summary: Evaluating the evidence base to support the inclusion of infants and children from birth to 24 mo of age in the Dietary Guidelines for Americans—The B-24 Project. American Journal of Clinical Nutrition 99:663S–691S. https://www.ncbi.nlm.nih.gov/pubmed/24500158#_blank.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

In addition to the P/B-24 Project, NESR previously collaborated with other expert groups to conduct a number of systematic reviews on questions relevant to the 2020 Advisory Committee’s work. Therefore, when possible, the Advisory Committee used these relevant, timely, high-quality, and transparently documented existing NESR reviews.

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. For example, federal staff updated background files with the latest data to support food pattern modeling and initiated analyses specific to pregnancy and lactation. Staff from ODPHP and CNPP also collaborated with colleagues at the U.S. Food and Drug Administration to discuss processes used to identify nutrients of concern and health claims. Finally, the Data Analysis Team, including staff from USDA’s Agricultural Research Service (ARS) and HHS’s Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) met to coordinate data needs, including NHANES analyses.

For 1c, USDA and HHS provided substantial staff and contractor support before and during the process to support the committee’s scientific review. This staff support allowed the Advisory Committee to focus on (1) drawing conclusions and (2) integrating the evidence to provide advice to the departments. While staff supported analyses, the conclusions presented in the committee’s report are those of the Advisory Committee. Additionally, the departments requested that the Advisory Committee provide advice to the agencies in the “summary” sections of each of the science-based chapters of its report. Also, for the first time in the DGA process, the Advisory Committee’s final meeting focused on its draft report. This meeting allowed for discussion and deliberation by the full Advisory Committee before submitting its report to the secretaries of USDA and HHS. In these ways, the departments supported separation of roles and responsibilities to allow the committee to focus on drawing conclusions and preparing advice for the departments.

In line with the recommendation to distribute responsibilities, there is also separation of the evidence review conducted by the Advisory Committee and the development and publication of the DGA by USDA and HHS. This approach is in line with best practices in guideline development, which includes organizing an effective guideline development group and the use of evidence to inform recommendations.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

Report 2, recommendation 3: The secretary of the U.S. Department of Agriculture (USDA) should clearly separate the roles of USDA Nutrition Evidence Library (NEL) staff and the Dietary Guidelines Scientific Advisory Committee (DGSAC) such that

  1. The NEL staff plan and conduct systematic reviews with input from technical expert panels, perform risk-of-bias assessment of individual studies, and assist the DGSAC as needed.
  2. The NEL systematic reviews are externally peer reviewed prior to being made available for use by the DGSAC.
  3. The DGSAC synthesizes and interprets the results of systematic reviews and draws conclusions about the entire body of evidence.

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. In the Pregnancy and Birth to 24 Months Project, NESR conducted systematic reviews with input from technical expert panels in advance of convening the 2020 committee as described in Recommendation 1. However, the process described below aligns with Recommendation 3.

The NESR team used its rigorous, protocol-driven methodology to support the 2020 Advisory Committee to conduct systematic reviews. NESR’s methods are designed to promote transparency, minimize bias, and ensure the public availability, via NESR.usda.gov and peer-reviewed publications, of systematic reviews that are relevant, timely, and high quality. NESR’s methodology is based on and aligns with that of other systematic review organizations, such as Cochrane, the Agency for Healthcare Research and Quality, and other U.S. and international entities that conduct systematic reviews to inform public health guidance.

NESR’s general methodology for answering a systematic review question involves

  • developing a protocol,
  • searching for and selecting articles,
  • extracting data and assessing the risk of bias of results from each included article,
  • synthesizing the evidence,
  • developing conclusion statements,
  • grading the evidence underlying the conclusion statements, and
  • recommending future research.
Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

NESR reviews were completed in a collaborative manner between the NESR team and the committee. The NESR team, which has expertise in systematic review methodology, has advanced degrees in nutrition, public health, epidemiology, psychology, library science, or a related field. The committee members hold advanced degrees in medicine or science and included experts that are nutrition scientists, physicians, dietitians, epidemiologists, and clinicians.

The NESR team and the 2020 Advisory Committee had distinct roles in the systematic review process. 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. Each protocol included the analytic framework and inclusion and exclusion criteria. The NESR team then developed and implemented the literature search strategy, screened the literature search results using the Advisory Committee’s inclusion and exclusion criteria, and extracted data and assessed risk of bias for each study included in the systematic review. Then, the Advisory Committee synthesized the body of evidence; developed conclusion statements that answered the systematic review question; and graded the strength of evidence supporting the conclusions.

New to the 2020 process, the departments added a step for peer review of the systematic reviews conducted by the Advisory Committee. This step was added in response to recommendations from the National Academies as well as stakeholder comments, and in acknowledgement that peer review is a best practice for conducting systematic reviews. Per the Advisory Committee’s charter, peer review was coordinated by the co-executive secretary from USDA’s Agricultural Research Service (ARS), which developed a peer-review process analogous to that used for academic journal articles. Each systematic review was peer reviewed by 2 federal scientists. In total, 47 federal scientists from USDA, HHS (including NIH, CDC, and FDA), DoD, and the VA participated in the process.

The peer-review process was anonymous and confidential. Peer-reviewer comments were provided to the Advisory Committee and to the NESR team. NESR reviewed the comments, addressed editorial comments, and proposed edits to the committee in response to comments related to content, including clarity and rationale for decisions made by the committee in developing conclusion statements and grading the strength of the evidence. Substantive comments were reviewed and discussed by the committee, and revisions were made to the systematic review, as needed, based on the committee’s discussion.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

Detailed information on the Advisory Committee’s peer review and its review of the evidence is documented in its scientific report, which is available on DietaryGuidelines.gov.

Report 2, recommendation 4: The secretary of the U.S. Department of Agriculture should ensure all Nutrition Evidence Library (NEL) systematic reviews align with best practices by

  1. Enabling ongoing training of the NEL staff,
  2. Enabling engagement with and learning from external groups on the forefront of systematic review methods,
  3. Inviting external systematic review experts to periodically evaluate the NEL’s methods, and
  4. Investing in technological infrastructure.

Response: Systematic review science and supporting technologies evolve continuously. The field of nutrition science is also progressing in areas related to the design, conduct, and analysis of food- and nutrition-related research. 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.

When appropriate and feasible, refinements to the NESR methodology are carefully planned, tested, and adopted. Examples of process improvements that NESR made prior to supporting the 2020 Advisory Committee related to (1) tools and processes for assessing the risks of bias of primary research, (2) criteria for grading the strength of evidence underlying the conclusion drawn in NESR systematic reviews; and (3) technology to support efficient and accurate searching for and screening of studies, as well as data extraction.

A recent best practice in the field of systematic review methodology is to publicly post protocols prior to initiating the review of evidence. NESR, in conjunction with the 2020 Advisory Committee, publicly posted the protocols for each systematic review prior to the Advisory Committee’s review of evidence. Protocols have always been part of NESR’s process, but this was the first time they were posted online prior to the evidence review. The Advisory Committee established their protocols before any evidence was reviewed and synthesized. This allowed the Advisory Com-

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

mittee to establish protocols that would capture the most appropriate, relevant, and direct body of evidence to answer each question. All systematic review protocols were posted online to provide transparency and an opportunity for the public to provide comments. Protocols also were presented and discussed at Advisory Committee meetings. Any revisions to protocols that occurred during the course of the Advisory Committee’s work were documented, posted online, and presented at meetings. The literature search plan (i.e., search terms) and screening results (i.e., flow chart, included and excluded articles) were added to the protocols online as they were finalized.

The Advisory Committee’s review of the evidence is an iterative process (i.e., not all questions move through each step at the same time). A webpage on DietaryGuidelines.gov was created to help the public follow the Advisory Committee’s review of each scientific question and where it was in the review process. The page included a legend at the top depicting key steps in the review process, including protocol development, implementation, and when a draft conclusion statement was posted. These key steps were used to allow the public to track where each question was in the process. This page was updated regularly and often throughout the Advisory Committee’s work.

By aligning with current best practices, NESR’s Continuous Quality Advancement initiative promotes efficiency and resource management and ensures the ongoing high quality and credibility of NESR work.

Report 2, recommendation 5: The secretaries of the U.S. Department of Agriculture and the U.S. 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. The food pattern modeling analysis approach helps explain how changes to food-based dietary recommendations could potentially affect Americans’ ability to meet their nutrient needs. For the DGA development process, food pattern modeling was used to answer a portion of the topics and to support scientific questions the Advisory Committee examined. These questions looked at

  • The ability to meet nutrient recommendations for each stage of life through variations in USDA Food Patterns,
Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×
  • Development of two USDA food patterns for ages 12 through 23 months, and
  • The relationship between added sugars consumption and achieving nutrient and food group recommendations.

The analytic methods and development of data inputs and constraints for food pattern modeling have been evaluated and compared to methods used in the development of guidance in other countries as well as other modeling exercises described in scientific publications. This effort is part of USDA’s commitment to drive continuous process advancements and adopt best practices. The data inputs and constraints are the foundation for food pattern modeling, and when compared to external examples, they align with best practices and exceed expectations for transparent documentation. 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.

Food pattern modeling relies on food composition data from the USDA Food and Nutrient Database for Dietary Studies (FNDDS) and Standard Reference (SR). These sources provide comprehensive nutrient data on food choices of Americans. Since the previous edition of the DGA, additional foods have been added to FNDDS to better reflect the current food supply and the increased variability of what Americans are eating. This increased variability was used during food pattern modeling exercises conducted to inform the development of patterns for the DGA. Future editions of FNDDS will integrate expanded nutrient profile data and links to related agricultural and experimental research.

To account for variation in eating patterns across different age groups, a new approach was employed to describe the nutrient profiles used in analyses. In the past, nutrient profiles were calculated using data for ages 2 and older. In the 2020 process, proportions by life stage were calculated for infants and toddlers under age 2, ages 2 to 3 years, 4 to 18 years, 19 to 70 years, and 71 years and older. Using the nutrients in each representative food and the item cluster’s proportional intake using the life-stage approach, a nutrient profile was calculated for each food group or subgroup. Thus, a nutrient profile specific to each life stage was developed and then used to estimate the anticipated nutrients and other food components in the patterns.

Food pattern modeling explores the development of dietary patterns applicable to the American population. The 2015–2020 edition of the DGA

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

recognized that there are many ways to achieve a healthful dietary pattern and highlighted three dietary patterns that have demonstrated health benefits: (1) the Healthy U.S.-Style Eating Pattern, (2) the Healthy Mediterranean-Style Eating Pattern, and (3) the Healthy Vegetarian Eating Pattern. 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.

USDA plans to continue to advance food pattern modeling through activities including engagement with external experts. These efforts will ensure that USDA’s food pattern modeling stays current with best practices, provides evidence-based eating patterns for Americans, and demonstrates USDA’s commitment to process improvement.

Report 2, recommendation 6: The secretaries of the U.S. Department of Agriculture and the U.S. Department of Health and Human Services should standardize the methods and criteria for establishing nutrients of concern.

Response: USDA and HHS have explored other federal processes for evaluating potential nutrients of concern, like FDA’s Evaluation Process of Public Health Significance of Essential Vitamins and Minerals, to standardize methods and criteria for establishing nutrients of concern across the federal government. A three-step process was established to identify nutrients of public health concern: (1) estimate U.S. population intake levels for essential vitamins and minerals as compared to Dietary Reference Intakes; (2) if possible, consider biological endpoints such as biochemical indices of nutritional status with valid cut-points; and (3) consider scientific evidence on the relationship between nutrient inadequacy or excess and clinical health consequences.

Like NESR systematic reviews and food pattern modeling, a protocol was developed with the 2020 Advisory Committee and posted to DietaryGuidelines.gov for public input before any data was reviewed and synthesized. The protocol was also presented and discussed at Advisory Committee meetings. The protocol included the analytic framework that described the three-step process used to identify nutrients of public health concern and the analytic plan that detailed the data and subsequent analysis to be conducted. This method was further standardized through the scientific report of the 2020 Dietary Guidelines Advisory Committee and

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

publication in the peer-reviewed literature (Bailey et al. 2021. A proposed framework for identifying nutrients and food components of public health relevance in the Dietary Guidelines for Americans. Journal of Nutrition).

Report 2, recommendation 7: The secretaries of the U.S. Department of Agriculture and the U.S. Department of Health and Human Services should commission research and evaluate strategies to develop and implement systems approaches into the Dietary Guidelines for Americans (DGA). The selected strategies should then begin to be used to integrate systems mapping and modeling into the DGA process.

Response: USDA and HHS recognize the importance of exploring how to integrate systems approaches into the DGA process. CNPP has sought funding to do so each fiscal year since 2018 but has yet to secure any funds. Contingent on funding, the departments hope to start the departments plan to start the important process of looking at best practices regarding how the complex methodology of systems approaches can be adapted and applied to the DGA as effectively as possible, while ensuring that the DGA continues to reflect the highest scientific integrity and to contain information adaptable for consumer use.

Report 2, recommendation 2: The secretaries of the U.S. Department of Agriculture and the U.S. Department of Health and Human Services should provide the public with a clear explanation when the Dietary Guidelines for Americans (DGA) omit or accept only parts of conclusions from the scientific report.

Response: USDA and HHS support this recommendation, which aligns with the value of transparency. 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

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

infants and toddlers. With the release of the 2020–2025 edition, the departments made clear, through a written response70 that was posted to DietaryGuidelines.gov, the deliberations around decisions related to certain recommendations from the Advisory Committee’s scientific report that were not carried forward into the DGA. The response provided additional clarity and transparency to the DGA process.

CONCLUSION

USDA and HHS have thoroughly considered all the recommendations from both National Academies reports and incorporated as many of them as possible in the process to develop the Dietary Guidelines for Americans, 2020–2025. Future cycles of the DGA will continue to reexamine the National Academies reports and consider how their recommendations may be incorporated. The departments appreciate the National Academies’ review of the DGA process and its thoughtful recommendations to improve the process.

APPENDIX B-6
QUESTION TO THE U.S. DEPARTMENT OF AGRICULTURE (USDA) AND USDA RESPONSE TO THE NATIONAL ACADEMIES (SEPTEMBER 21, 2021)

Question: It would be helpful to be able to see where changes or updates to the systematic review protocols were posted. For example, if there were adjustments made to the search strategy, would the new strategy have been posted somewhere, or is this information available? It would be really helpful for us to have some guidance on any systematic review updates in order to be as accurate as possible in our assessment.

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.

Each systematic review protocol included the following information:

___________________

70 See https://www.dietaryguidelines.gov/about-dietary-guidelines/related-projects/usda-hhs-response-national-academies-sciences-engineering.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×
  • Overview of NESR’s systematic review methodology
  • If applicable, details about the existing NESR reviews that were being updated
  • Analytic framework
  • Literature search and screening plan
    • Inclusion and exclusion criteria
    • Electronic databases
    • Note: Search terms were documented in the protocols reviewed by the committee. Search terms were not included in the draft protocols posted to DietaryGuidelines.gov owing to their length; however, as noted in the example protocols attached, search terms were available upon request. During the committee’s 16-month review, one request for search terms was received from the public. Search terms were added to the final posted protocols and are documented in the full systematic reviews that are available on NESR.usda.gov
  • Literature search and screening results (added as they were finalized)
    • Flow chart of literature search and screening results
    • List of included articles
    • List of excluded articles, with rationale

All systematic review protocols were posted online, at www.DietaryGuidelines.gov, to provide transparency and an opportunity for the public to provide comments. Protocols also were presented and discussed at meetings of the full committee. In addition, an email notification went out to subscribers directing them to DietaryGuidelines.gov for new and updated information about the committee’s review, including protocol updates (see attachments for examples of email notifications).

Any revisions to protocols that occurred during the course of the committee’s work were documented in updated protocols that were posted online, with updates listed, prior to committee meetings and presented at the meetings. The final protocols, as they were implemented, are published in each systematic review report, found on NESR.usda.gov. In addition, the committee described substantive changes that occurred to their protocols in their report chapters.

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

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×

committee. There were few, if any, revisions made to search strategies during the course of the committee’s work. 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. NESR analysts ensured that the articles were searched, screened, and included based on the updated, final protocols established by the committee.

Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
×
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Suggested Citation:"Appendix B: Open Session Agendas and Comments." National Academies of Sciences, Engineering, and Medicine. 2022. Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025: A Midcourse Report. Washington, DC: The National Academies Press. doi: 10.17226/26406.
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This midcourse report provides an initial assessment of how the process used to develop the Dietary Guidelines for Americans, 2020-2025 (DGA) compares to the recommendations in the 2017 National Academies report on redesigning the process for establishing the DGA. It also assesses the criteria and processes for including the scientific studies used to develop the guidelines. The scope of this study was to address the process and not the content of the guidelines.

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