Boye Kristina S, Sapin Hélène, García-Pérez Luis-Emilio, Rosilio Myriam, Orsini Federici Marco, Heitmann Elke, Jung Heike, Aigner Ulrich, Guerci Bruno, Giorgino Francesco, Norrbacka Kirsi
Eli Lilly and Company, Indianapolis, IN, USA.
Lilly France SAS, Neuilly-sur-Seine, France.
Diabetes Ther. 2020 Oct;11(10):2383-2399. doi: 10.1007/s13300-020-00908-9. Epub 2020 Sep 3.
Although patient-reported outcome (PRO) measures provide important information beyond clinical data, studies that assess the PROs of type 2 diabetes mellitus (T2DM) patients initiating injectable glucose-lowering medications in routine clinical practice are limited. We describe the perspectives of patients based on a diversified panel of generic and disease-specific PRO measures at the time of enrollment (baseline) in the TROPHIES study.
TROPHIES is a 24-month prospective observational study performed in France, Germany, and Italy in patients with T2DM who initiated their first injectable glucose-lowering medication with once-weekly dulaglutide or once-daily liraglutide. To better understand the perspectives of these patients regarding their overall health, treatment satisfaction, and quality of life and work, the patients' responses to the following questionnaires were collected at baseline before they initiated treatment with dulaglutide or liraglutide: EQ-5D-5L (scale: 0-1), EQ-VAS (visual analog scale: 0-100), Impact of Weight on Self-Perceptions Questionnaire (IW-SP; scale: 0-100), Diabetes Treatment Satisfaction Questionnaire Status (DTSQs; scale: 0-36), and Diabetes Productivity Measure (DPM; scale: 0-100). Analyses were descriptive in nature, with higher scores reflecting better outcomes.
Data from patients at the time of enrollment were analyzed. At baseline, patients initiating dulaglutide (N = 1130) or liraglutide (N = 1051) rated their quality of life in terms of mean EQ-5D-5L index as 0.84 and 0.83, and in terms of mean EQ-VAS as 67.5 and 67.5, respectively. The mean baseline scores in patients initiating dulaglutide or liraglutide were 59.8 and 61.3 for IW-SP, 24.6 and 25.8 for DTSQs, 78.6 and 79.5 for DPM Life Productivity, and 87.5 and 86.8 for DPM Work Productivity, respectively.
The information from this varied panel of PRO instruments collected at baseline complements clinical outcomes data.
尽管患者报告结局（PRO）测量提供了超出临床数据的重要信息，但在常规临床实践中评估开始使用注射用降糖药物的2型糖尿病（T2DM）患者PRO的研究有限。我们在TROPHIES研究入组（基线）时，基于一组多样化的通用和疾病特异性PRO测量方法描述了患者的观点。
TROPHIES是一项在法国、德国和意大利对T2DM患者进行的为期24个月的前瞻性观察性研究，这些患者开始首次使用每周一次的度拉糖肽或每日一次的利拉鲁肽进行注射用降糖治疗。为了更好地了解这些患者对其整体健康、治疗满意度以及生活和工作质量的看法，在患者开始使用度拉糖肽或利拉鲁肽治疗前的基线时收集了他们对以下问卷的回答：EQ-5D-5L（量表：0-1）、EQ-VAS（视觉模拟量表：0-100）、体重对自我认知问卷（IW-SP；量表：0-100）、糖尿病治疗满意度问卷状态（DTSQs；量表：0-36）以及糖尿病生产力测量（DPM；量表：0-100）。分析本质上是描述性的，分数越高反映结果越好。
对入组时患者的数据进行了分析。在基线时，开始使用度拉糖肽（N = 1130）或利拉鲁肽（N = 1051）的患者，其平均EQ-5D-5L指数分别将生活质量评为0.84和0.83，平均EQ-VAS分别评为67.5和67.5。开始使用度拉糖肽或利拉鲁肽的患者，IW-SP的平均基线分数分别为59.8和61.3，DTSQs分别为24.6和25.8，DPM生活生产力分别为78.6和79.5，DPM工作生产力分别为87.5和86.8。
在基线时从这组多样化的PRO工具收集的信息补充了临床结局数据。
