یک مرور دامنه ای در مورد مقررات مربوط به تغذیه پزشکی
Abstract
Introduction
Methods
Results
Discussion
Conclusion
References
Abstract
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.
Introduction
Medical nutrition (MN)-related terminology in the United States and Europe is not standardized, and the terms are often misused [1]. The term MN encompasses a range of products used as a clinical nutrition therapy to manage disease- and condition-related nutritional needs [1,2]. Clinical nutrition refers to the discipline as a whole that deals with the prevention, diagnosis, and management of nutritional and metabolic changes related to acute and chronic diseases/conditions caused by a lack or excess of energy and nutrients [2]. MN is indicated in clinical situations, such as for infants with special needs, disease-related malnutrition, and other medical conditions in which there is an increased risk of malnutrition, including surgery and trauma. In all circumstances, regulatory bodies require that MN is administered under the supervision of a medical professional, such as a physician, dietitian, or nurse [2].