Mozzillo Enza, Marigliano Marco, Troncone Alda, Maffeis Claudio, Morotti Elisa, Di Candia Francesca, Fedi Ludovica, Iafusco Dario, Zanfardino Angela, Cauvin Vittoria, Pertile Riccardo, Maltoni Giulio, Zucchini Stefano, Cherubini Valentino, Tiberi Valentina, Minuto Nicola, Bassi Marta, Rabbone Ivana, Savastio Silvia, Tinti Davide, Tornese Gianluca, Schiaffini Riccardo, Passanisi Stefano, Lombardo Fortunato, Bonfanti Riccardo, Scaramuzza Andrea, Franceschi Roberto
Department of Translational Medical Science, Section of Pediatrics, Università Degli Studi Di Napoli Federico II, Naples, Italy.
Department of Surgery, Dentistry, Pediatrics and Gynecology, Section of Pediatric Diabetes and Metabolism, University and Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.
Acta Diabetol. 2023 May;60(5):673-679. doi: 10.1007/s00592-023-02043-w. Epub 2023 Feb 20.
Patient-reported outcomes (PROs) are increasingly important for assessing patient satisfaction with diabetes technologies. PROs must be assessed with validated questionnaires in clinical practice and research studies. Our aim was to translate and validate the Italian version of the continuous glucose monitoring (CGM) Satisfaction (CGM-SAT) scale questionnaire.
Questionnaire validation followed MAPI Research Trust guidelines and included forward translation, reconciliation, backward translation, and cognitive debriefing.
The final version of the questionnaire was administered to 210 patients with type 1 diabetes (T1D) and 232 parents. The completion rate was excellent, with almost 100% of items answered. The overall Cronbach's coefficient was 0.71 and 0.85 for young people (patients) and parents indicating moderate and good internal consistency, respectively. Parent-young people agreement was 0.404 (95% confidence interval: 0.391-0.417), indicating moderate agreement between the two assessments. Factor analysis identified that factors assessing the "benefits" and "hassles" of CGM accounted for 33.9% and 12.9% of score variance in young people and 29.6% and 19.8% in parents, respectively.
We present the successful Italian translation and validation of the CGM-SAT scale questionnaire, which will be useful for assessing satisfaction with Italian T1D patients using CGM systems.
患者报告结局（PROs）对于评估患者对糖尿病技术的满意度日益重要。在临床实践和研究中，必须使用经过验证的问卷来评估PROs。我们的目的是翻译并验证连续血糖监测（CGM）满意度（CGM-SAT）量表问卷的意大利语版本。
问卷验证遵循MAPI研究信托指南，包括正向翻译、核对、反向翻译和认知反馈。
该问卷的最终版本被发放给210名1型糖尿病（T1D）患者和232名家长。完成率很高，几乎所有项目都得到了回答。年轻人（患者）和家长的总体克朗巴哈系数分别为0.71和0.85，表明内部一致性中等和良好。家长与年轻人的一致性为0.404（95%置信区间：0.391 - 0.417），表明两种评估之间的一致性中等。因子分析表明，评估CGM“益处”和“麻烦”的因子分别占年轻人得分方差的33.9%和12.9%，占家长得分方差的29.6%和19.8%。
我们展示了CGM-SAT量表问卷成功的意大利语翻译和验证，这将有助于评估意大利1型糖尿病患者对使用CGM系统的满意度。
