Fastenau John, Rozjabek Heather, Qin Shanshan, McLeod Lori, Nelson Lauren, Ma Jia, Harris Nimanee
Janssen, 700 US Highway Route 202, Raritan, NJ, 08869, USA.
RTI Health Solutions, 3040 East Cornwallis Road, Post Office Box 12194, Research Triangle Park, NC, 27709-2194, USA.
J Patient Rep Outcomes. 2020 Nov 23;4(1):99. doi: 10.1186/s41687-020-00259-w.
Physiological and behavioral factors including hunger, satiety, food intake, and cravings are health determinants contributing to obesity. Patient-reported outcome (PRO) measures focused on eating-related factors provide insight into the relationships between food choice and quantity, weight change, and weight-loss treatment for individuals living with obesity. The DAILY EATS is a novel 5-item, patient-reported measure evaluating key eating-related factors (Worst and Average Hunger, Appetite, Cravings, and Satiety).
Psychometric analyses, consistent with regulatory standards, were conducted to evaluate the DAILY EATS using data from two randomized trials that included individuals with severe obesity without diabetes (NCT03486392) and with severe obesity and type 2 diabetes (NCT03586830). Additional measures included Patient Global Impression of Status (PGIS) and Patient Global Impression of Change items, Impact of Weight on Quality of Life-Lite, Ease of Weight Management, and Patient-Reported Outcomes Measurement Information System Physical Function Short Form 8b and 10a. The reliability, validity, and responsiveness of the DAILY EATS were assessed, and a scoring algorithm and thresholds to interpret meaningful score changes were developed.
Item-level analyses of the DAILY EATS supported computation of an Eating Drivers Index (EDI), comprising the related items Worst Hunger, Appetite, and Cravings. Internal consistency (Cronbach's coefficient alphas ≥0.80) and test-retest reliability (coefficients > 0.7) of the EDI were robust. Construct validity correlation patterns with other PRO measures were as hypothesized, with moderate to strong significant correlations between the EDI and PGIS-Hunger (0.30 ≤ r ≤ 0.68), PGIS-Cravings (0.33 ≤ r ≤ 0.77) and PGIS-Appetite (0.52 ≤ r ≤ 0.77). Anchor- and distribution-based analyses support reductions ranging from 1.6 to 2.1 as responder thresholds for the EDI, representing meaningful within-person improvement.
The DAILY EATS individual items and the composite EDI are reliable, sensitive, and valid in evaluating the concepts of hunger, appetite, and cravings for use in individuals with severe obesity with or without type 2 diabetes.
包括饥饿、饱腹感、食物摄入量和渴望在内的生理和行为因素是导致肥胖的健康决定因素。关注饮食相关因素的患者报告结局（PRO）指标有助于深入了解肥胖个体的食物选择与摄入量、体重变化以及减肥治疗之间的关系。DAILY EATS是一项新颖的包含5个条目的患者报告指标，用于评估关键的饮食相关因素（最严重饥饿感、平均饥饿感、食欲、渴望和饱腹感）。
采用符合监管标准的心理测量分析方法，利用两项随机试验的数据对DAILY EATS进行评估。这两项试验的对象分别为无糖尿病的重度肥胖个体（NCT03486392）以及患有重度肥胖和2型糖尿病的个体（NCT03586830）。其他测量指标包括患者总体状况印象（PGIS）和患者总体变化印象条目、体重对生活质量的影响-简易版、体重管理的难易程度，以及患者报告结局测量信息系统身体功能简表8b和10a。评估了DAILY EATS的可靠性、有效性和反应性，并制定了用于解释有意义分数变化的评分算法和阈值。
对DAILY EATS的条目水平分析支持计算饮食驱动指数（EDI），该指数由相关条目最严重饥饿感、食欲和渴望组成。EDI的内部一致性（克朗巴赫系数α≥0.80）和重测信度（系数>0.7）都很强。与其他PRO指标的结构效度相关模式符合假设，EDI与PGIS-饥饿感（0.30≤r≤0.68）、PGIS-渴望（0.33≤r≤0.77）和PGIS-食欲（0.52≤r≤0.77）之间存在中度至强显著相关性。基于锚定和分布的分析支持将1.6至2.1的降幅作为EDI的反应者阈值，代表个体内部有意义的改善。
DAILY EATS的单个条目和综合EDI在评估有或无2型糖尿病的重度肥胖个体的饥饿、食欲和渴望概念方面是可靠、敏感且有效的。
