Beauger Davy, Fruit Dorothée, Villeneuve Claire, Laroche Marie-Laure, Jouve Elisabeth, Rousseau Annick, Boyer Laurent, Gentile Stéphanie
EA 3279 - Public Health, Chronic Diseases and Quality of Life - Research Unit, Aix-Marseille University, 13005, Marseille, France.
Department of Pharmacology, Toxicology and Centre of Pharmacovigilance, CHU Limoges, Limoges, France.
Qual Life Res. 2016 Sep;25(9):2347-59. doi: 10.1007/s11136-016-1271-0. Epub 2016 Mar 26.
Renal transplantation is considered as the treatment of choice for patients with end-stage renal disease. Health-related quality of life (HRQoL) of renal transplant recipients (RTR) is very important to assess, especially during the first year after transplantation. To provide new evidence about the suitability of HRQoL measures in RTR during the first post-transplant year, we explored the internal structure, reliability and external validity of a French specific HRQoL instrument, the Renal Transplant Quality of life Questionnaire Second Version (RTQ V2).
The data were issued from the French multicenter cohort of renal transplant patients followed during 4 years (EPIGREN). The HRQoL of RTR was assessed five times (at 1, 3, 6, 9 and 12 months after transplantation) with the RTQ V2, a specific instrument consisting of 32 items describing five dimensions. Socio-demographic information, clinical characteristics and HRQoL (i.e., RTQ V2 and SF-36) were collected. For the five times, psychometric properties of the RTQ V2 were compared to those reported from the reference population assessed in the validation study.
Three hundred and thirty-four patients were enrolled. The proportions of well-projected items, item-internal consistency, item-discriminant validity, floor and ceiling effects, Cronbach's alpha coefficients and item goodness-of-fit statistics were satisfactory for each dimension at the five times of the study. The suitability indices of construct validity were higher than 90 % for each time (minimum-maximum: 90.8-97.4 %). The external validity was less satisfactory, with a suitability indices ranged from 46.7 % at M1 to 66.7 % at M12. However, the discrepancies with the reference population (mainly for the gender) appeared logical considering the scientific literature on HRQoL of RTR during the first post-transplant year and may not compromise the external validity.
These results support the validity and reliability of the RTQ V2 for evaluating HRQoL in RTR during the first post-transplant year, and confirm that the RTQ V2 is a useful tool to assess the HRQoL precociously after transplant.
肾移植被视为终末期肾病患者的首选治疗方法。评估肾移植受者（RTR）与健康相关的生活质量（HRQoL）非常重要，尤其是在移植后的第一年。为了提供关于HRQoL测量方法在移植后第一年RTR中适用性的新证据，我们探讨了一种法国特定的HRQoL工具——肾移植生活质量问卷第二版（RTQ V2）的内部结构、信度和外部效度。
数据来自法国多中心肾移植患者队列，随访4年（EPIGREN）。使用RTQ V2对RTR的HRQoL进行了五次评估（移植后1、3、6、9和12个月），RTQ V2是一种由32个项目组成的特定工具，描述五个维度。收集了社会人口学信息、临床特征和HRQoL（即RTQ V2和SF-36）。在这五次评估中，将RTQ V2的心理测量特性与验证研究中评估的参考人群报告的特性进行了比较。
共纳入334例患者。在研究的五次评估中，每个维度的项目预期比例、项目内部一致性、项目区分效度、地板效应和天花板效应、克朗巴哈α系数以及项目拟合优度统计数据均令人满意。每次的结构效度适宜性指数均高于90%（最小值-最大值：90.8-97.4%）。外部效度不太令人满意，适宜性指数范围从M1时的46.7%到M12时的66.7%。然而，如果考虑到关于移植后第一年RTR的HRQoL的科学文献，与参考人群的差异（主要是性别方面）似乎是合理的，可能不会损害外部效度。
这些结果支持RTQ V2在评估移植后第一年RTR的HRQoL方面的效度和信度，并证实RTQ V2是移植后早期评估HRQoL的有用工具。
