TY - JOUR
T1 - Medical Nutrition Terminology and Regulations in the United States and Europe-A Scoping Review
T2 - Report of the ISPOR Nutrition Economics Special Interest Group
AU - Freijer, Karen
AU - Volger, Sheri
AU - Pitter, Janos G.
AU - Molsen-David, Elizabeth
AU - Cooblall, Clarissa
AU - Evers, Silvia
AU - Hiligsmann, Mickael
AU - Danel, Aurelie
AU - Lenoir-Wijnkoop, Irene
AU - Patridge, Jamie
AU - Goates, Scott
AU - Laplante, Suzanne
AU - Seyhun, Oznur
AU - Aggarwal, Bhagwan
AU - Ofili, Theresa
AU - ISPOR Nutrition Economics Medical Nutrition Terms & Definitions Working Group’s Leadership Team‡
N1 - Funding Information:
Source of financial support: This research was supported in part by ISPOR, which contributed two staff liaisons for this project.
Funding Information:
This article was developed as a collaborative effort of members of the ISPOR Nutrition Economics Special Interest Group (SIG). We thank all reviewers who commented during our forums and open meeting presentations at the ISPOR Annual International Meetings and ISPOR European Congresses (Washington, DC, and Boston, MA, USA, and Milan, Italy, and Glasgow, Scotland, UK, respectively). We especially thank the individuals who submitted written comments on drafts of our manuscript. Both oral and written feedback significantly improved the quality of this report and contributed to the consensus nature of this ISPOR SIG manuscript. The following submitted feedback: Representatives from the international medical nutrition industry: Ylva Orrevall, Manfred Ruthsatz, Pierre Sagnier, Jos Schols, Frode Slinde, Matthew Taylor, and Luzia Valentini. Members from the Nutrition Economics SIG: Bhagwan Aggarwal, Nicole Antipas, Nermeen Ashoush, Michael Cangelosi, Aurelie Danel, Dominique Dubois, ?kos J?zwiak, Agnieszka Marczewska, Josephine Mauskopf, and Kristen Migliaccio-Walle. We also thank our student SIG members for their assistance in reviewing and extracting data for this project: Noemi Kiss, Kaitlyn Lenahan, Yidan Lu, and Tania Yuba. None of the authors received financial support for their participation in this SIG. All authors volunteered their time for discussion, research, and writing of this report. Source of financial support: This research was supported in part by ISPOR, which contributed two staff liaisons for this project.
Publisher Copyright:
© 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research
PY - 2019/1
Y1 - 2019/1
N2 - Background: The term medical nutrition ( MN) refers to nutritional products used under medical supervision to manage disease- or condition-related dietary needs. Standardized MN definitions, aligned with regulatory definitions, are needed to facilitate outcomes research and economic evaluation of interventions with MN. Objectives: Ascertain how MN terms are defined, relevant regulations are applied, and to what extent MN is valued. Methods: ISPOR's Nutrition Economics Special Interest Group conducted a scoping review of scientific literature on European and US MN terminology and regulations, published between January 2000 and August 2015, and pertinent professional and regulatory Web sites. Data were extracted, reviewed, and reconciled using two-person teams in a two-step process. The literature search was updated before manuscript completion. Results: Of the initial 1687 literature abstracts and 222 Web sites identified, 459 records were included in the analysis, of which 308 used MN terms and 100 provided definitions. More than 13 primary disease groups as per International Classification of Disease, Revision 10 categories were included. The most frequently mentioned and defined terms were enteral nutrition and malnutrition. Less than 5% of the records referenced any MN regulation. The health economic impact of MN was rarely and insufficiently (n = 19 [4.1%]) assessed, although an increase in economic analyses was observed. Conclusions: MN terminology is not consistently defined, relevant European and US regulations are rarely cited, and economic evaluations are infrequently conducted. We recommend adopting consensus MN terms and definitions, for example, the European Society for Clinical Nutrition and Metabolism consensus guideline 2017, as a foundation for developing reliable and standardized medical nutrition economic methodologies.
AB - Background: The term medical nutrition ( MN) refers to nutritional products used under medical supervision to manage disease- or condition-related dietary needs. Standardized MN definitions, aligned with regulatory definitions, are needed to facilitate outcomes research and economic evaluation of interventions with MN. Objectives: Ascertain how MN terms are defined, relevant regulations are applied, and to what extent MN is valued. Methods: ISPOR's Nutrition Economics Special Interest Group conducted a scoping review of scientific literature on European and US MN terminology and regulations, published between January 2000 and August 2015, and pertinent professional and regulatory Web sites. Data were extracted, reviewed, and reconciled using two-person teams in a two-step process. The literature search was updated before manuscript completion. Results: Of the initial 1687 literature abstracts and 222 Web sites identified, 459 records were included in the analysis, of which 308 used MN terms and 100 provided definitions. More than 13 primary disease groups as per International Classification of Disease, Revision 10 categories were included. The most frequently mentioned and defined terms were enteral nutrition and malnutrition. Less than 5% of the records referenced any MN regulation. The health economic impact of MN was rarely and insufficiently (n = 19 [4.1%]) assessed, although an increase in economic analyses was observed. Conclusions: MN terminology is not consistently defined, relevant European and US regulations are rarely cited, and economic evaluations are infrequently conducted. We recommend adopting consensus MN terms and definitions, for example, the European Society for Clinical Nutrition and Metabolism consensus guideline 2017, as a foundation for developing reliable and standardized medical nutrition economic methodologies.
KW - enteral nutrition
KW - foods intended for specific groups
KW - malnutrition
KW - medical food
KW - medical nutrition
KW - nutrition economics
KW - nutritional support
KW - oral nutritional supplement
KW - parenteral nutrition
KW - EARLY ENTERAL NUTRITION
KW - INFLUENCE MALNUTRITION PREVALENCE
KW - PARENTERAL-NUTRITION
KW - SECONDARY ANALYSES
KW - CANCER-PATIENTS
KW - HOME RESIDENTS
KW - SAFE PRACTICES
KW - SUPPORT
KW - CARE
KW - DISEASE
U2 - 10.1016/j.jval.2018.07.879
DO - 10.1016/j.jval.2018.07.879
M3 - (Systematic) Review article
SN - 1098-3015
VL - 22
SP - 1
EP - 12
JO - Value in Health
JF - Value in Health
IS - 1
ER -