应用德尔菲法初步完善特殊医学用途配方食品综合评价指标体系:以2型糖尿病为例

Using Delphi method to preliminarily perfect the comprehensive evaluation index system of food for special medical purposes designed for type 2 diabetes mellitus patients

目的完善前期通过系统评价(systematic review,SR)初步构建的糖尿病特殊医学用途配方食品(FSMP)综合评价指标体系。方法通过德尔菲(Delphi)法对循证构建的糖尿病FSMP综合评价指标体系进行3轮专家咨询以确定最终的指标体系及其效果评判方法。结果经3轮咨询后确定的指标体系含一级目录指标4个,二级目录指标15个,三级目录指标20个,其中末端指标即直接用于实施评价的指标共27个。结论整套指标体系包括特医临床效果(M)、营养充足性(N)、安全性(S)和其他(O)4个方面。该指标体系的初步构建和完善回答了《特殊医学用途配方食品通则》中关于如何科学证实临床效果及安全性的问题,对完善FSMP上市前评价和上市后监管,评估医学营养治疗(MNT)特色及优势,提升营养经济及其社会效益有重大意义。

Objectives To use the Delphi method to preliminarily perfect the comprehensive evaluation index system which had been initially constructed by systematic review processes of diabetes food for special medical purposes(FSMP). Methods Three rounds of expert consultation by Delphi method were compared to define indices held in the evidence-based comprehensive evaluation index system of diabetes FSMP and ways to distinguish effects. Results The preliminary perfect index system after 3 rounds of expert consultation contained 4 primary directory indicators, 15 secondary directory indicators, and 20 tertiary indicators. Among them, the end index which could directly be used for evaluation contained a total of 27 indicators. Conclusions The index system is categorized into 4 segments of parameters, which are medical, nutritional, safety and other indices, which has addressed the problem posed by CFDA documents on how to scientifically validate the medical effect and safety of FSMP. It provides great significance to assess and supervise FSMP prior to and after it goes to public, assess characteristics and advantages of MNT, and improves nutrition economy and its social benefits.