April 5, 2017
Portland VA Research Foundation
Scientific Research Center
Attn: Scientific Information Packet Coordinator
P.O. Box 69539
Portland, OR 97239
Re: Request for Supplemental Evidence and Data Submissions: Supplemental Evidence and Data Request on Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors
Dear Sir or Madam,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Agency for Healthcare Research and Quality (AHRQ) related to its open docket regarding "Request for Supplemental Evidence and Data Submissions: Supplemental Evidence and Data Request on Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors," published in the Federal Register on March 6, 2017. Representing over 100,000 registered dietitian nutritionists (RDNs),a nutrition dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation's health through food and nutrition and to providing medical nutrition therapy (MNT)b and innovative research to meet the health needs of all citizens.
This request for supplemental evidence and data submissions is of particular interest to the Academy and our members because of members' roles conducting social and behavioral and clinical research, including through the Academy's Dietetics Practice Based Research Network (DPBRN), which has member sites in all 50 states. The DPBRN conducts, supports, promotes, and advocates research in practice-based settings by bringing practitioners and researchers together to identify research that is needed in practice settings, design high-quality research, obtain funding and carry that research out in real-life practice settings.
The Academy encourages AHRQ to take note of a completed but unpublished study that is registered with ClinicalTrials.gov at https://clinicaltrials.gov/ct2/show/NCT02130089 entitled "Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?" and sponsored by the Academy of Nutrition and Dietetics. ClinicalTrials.gov notes the purpose of the study:
The purpose of this project is to understand if more frequent education of dialysis patients (patients with kidney failure who get their blood cleaned and fluid removed by a machine instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that patients gain between dialysis sessions. Patients who usually gain more fluid than is considered ideal will be recruited for this project. Because all patients gain different amounts to start, data will be collected for 3 months while the patients receive their usual amount of dietitian education. Then the patients will receive intensive (2x/month) education on reducing sodium intake from the dietitian and the same data will be collected to see if they gain less after the education. After 3 months of intensive education, data will be collected for one more month to see if patients keep gaining less or if they go back to their old patterns.c
In addition to this exciting study and our research in numerous other areas, the Academy plans to conduct future projects with other chronic kidney disease populations including peritoneal dialysis, pre-dialysis and pediatric patients in the future. We appreciate the opportunity to comment on the request and look forward to working with you regarding our research going forward. Please contact either Jeanne Blankenship at 312/899-1730 or by email at firstname.lastname@example.org or Pepin Tuma at 202/775-8277, ext. 6001 or by email at email@example.com with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
a The Academy approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation’s food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
b Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process. According the Academy's definition, Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process. The provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/reassessment, nutrition diagnosis, nutrition intervention and nutrition monitoring and evaluation that typically results in the prevention, delay or management of diseases and/or conditions. [Academy of Nutrition and Dietetics. Definition of Terms List. Available at www.eatrightpro.org/scope/. Accessed April 2 2017.] The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans. Further, the Academy’s definition of MNT is broader than the definition of MNT in the Social Security Act (42 U.S.C. 1395(vv)(1)).
c ClinicalTrials.gov website. "Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?" Accessed April 2, 2017.