Ginocchio Daniela, Alfonsi Enrico, Mozzanica Francesco, Accornero Anna Rosa, Bergonzoni Antonella, Chiarello Giulia, De Luca Nicoletta, Farneti Daniele, Marilia Simonelli, Calcagno Paola, Turroni Valentina, Schindler Antonio
Audiology Unit, Department of Clinical Sciences and Community Health, University of Milan, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Department of Neurophysiology and Neurorehabilitation, National Institute of Neurology, "C. Mondino" Foundation IRCCS, University of Pavia, Pavia, Italy.
Dysphagia. 2016 Oct;31(5):626-34. doi: 10.1007/s00455-016-9720-z. Epub 2016 Jul 21.
The aim of the study was to evaluate the reliability and validity of the Italian SWAL-QOL (I-SWAL-QOL). The study consisted of five phases: item generation, reliability analysis, normative data generation, validity analysis, and responsiveness analysis. The item generation phase followed the five-step, cross-cultural, adaptation process of translation and back-translation. A group of 92 dysphagic patients was enrolled for the internal consistency analysis. Seventy-eight patients completed the I-SWAL-QOL twice, 2 weeks apart, for test-retest reliability analysis. A group of 200 asymptomatic subjects completed the I-SWAL-QOL for normative data generation. I-SWAL-QOL scores obtained by both the group of dysphagic subjects and asymptomatic ones were compared for validity analysis. I-SWAL-QOL scores were correlated with SF-36 scores in 67 patients with dysphagia for concurrent validity analysis. Finally, I-SWAL-QOL scores obtained in a group of 30 dysphagic patients before and after successful rehabilitation treatment were compared for responsiveness analysis. All the enrolled patients managed to complete the I-SWAL-QOL without needing any assistance, within 20 min. Internal consistency was acceptable for all I-SWAL-QOL subscales (α > 0.70). Test-retest reliability was also satisfactory for all subscales (ICC > 0.7). A significant difference between the dysphagic group and the control group was found in all I-SWAL-QOL subscales (p < 0.05). Mild to moderate correlations between I-SWAL-QOL and SF-36 subscales were observed. I-SWAL-QOL scores obtained in the pre-treatment condition were significantly lower than those obtained after swallowing rehabilitation. I-SWAL-QOL is reliable, valid, responsive to changes in QOL, and recommended for clinical practice and outcome research.
本研究的目的是评估意大利版吞咽生活质量量表(I-SWAL-QOL)的信度和效度。该研究包括五个阶段:条目生成、信度分析、常模数据生成、效度分析和反应度分析。条目生成阶段遵循翻译和回译的五步跨文化适应过程。招募了92名吞咽困难患者进行内部一致性分析。78名患者在间隔2周的时间内两次完成I-SWAL-QOL,用于重测信度分析。200名无症状受试者完成I-SWAL-QOL以生成常模数据。比较吞咽困难受试者组和无症状受试者组获得的I-SWAL-QOL分数进行效度分析。在67名吞咽困难患者中,将I-SWAL-QOL分数与SF-36分数进行相关性分析以进行同时效度分析。最后,比较30名吞咽困难患者在成功康复治疗前后获得的I-SWAL-QOL分数进行反应度分析。所有纳入的患者均能在20分钟内无需任何帮助完成I-SWAL-QOL。所有I-SWAL-QOL子量表的内部一致性均可接受(α>0.70)。所有子量表的重测信度也令人满意(ICC>0.7)。在所有I-SWAL-QOL子量表中,吞咽困难组和对照组之间均存在显著差异(p<0.05)。观察到I-SWAL-QOL与SF-36子量表之间存在轻度至中度相关性。治疗前获得的I-SWAL-QOL分数显著低于吞咽康复后获得的分数。I-SWAL-QOL是可靠的、有效的,对生活质量的变化有反应,推荐用于临床实践和结局研究。