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LARS 评分的义大利文版本:跨文化调适与验证。义大利外科肿瘤学会-结直肠肿瘤网络(SICO-CCN)合作研究。

The Italian version of the LARS score: cross-cultural adaptation and validation. An Italian Society of Surgical Oncology-Colorectal Cancer Network (SICO-CCN) collaborative study.

机构信息

Department of Oncology, Surgical Oncology and Digestive Surgery Unit, S Luigi University Hospital, University of Turin, Regione Gonzole 10, 10043, Orbassano, Turin, Italy.

Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.

出版信息

Int J Colorectal Dis. 2021 Aug;36(8):1805-1810. doi: 10.1007/s00384-021-03903-z. Epub 2021 Mar 11.

Abstract

PURPOSE

The LARS score is an internationally well-accepted questionnaire to assess low anterior resection syndrome, but currently there is no formally validated Italian version. The purpose of this study was to test the reliability and validity of the Italian version among Italian patients submitted to sphincter-sparing surgery for rectal cancer.

METHODS

The English version of the LARS score was translated into Italian following the forward-and-back translation process. A total of 147 patients filled out our version. Among them, 40 patients answered the questionnaire twice for the test-retest reliability phase. The validity of the LARS score was tested using convergent and discriminant validity indicators by correlating the EORTC QLQ-C30 and QLQ-CR29 questionnaires. The LARS score capability to differentiate groups of patients with different demographic or clinical features was also assessed.

RESULTS

The test-retest reliability was excellent in 87.5% of patients, remained in the same LARS category in both tests. The convergent validity phase showed a relevant relationship of the LARS score with the EORTC domains, which was significant for 7 of 15 EORTC QLQ-C30 subscales, and for 14 of 29 EORTC QLQ-CR29 subscales. The LARS score was able to discriminate patients who received radiotherapy (p = 0.0026), TME vs. PME (p = 0.0060), tumour site at < 10 cm from the anal verge (p = 0.0030) and history of protective stoma (p < 0.0001).

CONCLUSION

The Italian version of the LARS score is a valid and reliable tool for measuring LARS in Italian patients after SSS for rectal cancer.

摘要

目的

LARS 评分是一种国际上广泛认可的评估低位前切除术综合征的问卷,但目前尚无经过正式验证的意大利版本。本研究的目的是在接受保肛手术治疗直肠癌的意大利患者中测试 LARS 评分意大利版本的可靠性和有效性。

方法

采用正向和反向翻译的方法将 LARS 评分的英文版本翻译成意大利语。共有 147 名患者填写了我们的问卷。其中,40 名患者进行了两次测试以评估重测信度。通过与 EORTC QLQ-C30 和 QLQ-CR29 问卷相关联,使用收敛和判别有效性指标来测试 LARS 评分的有效性。还评估了 LARS 评分区分具有不同人口统计学或临床特征的患者组的能力。

结果

87.5%的患者重测信度极好,两次测试均保持相同的 LARS 类别。在收敛有效性阶段,LARS 评分与 EORTC 各领域具有显著相关性,其中 15 个 EORTC QLQ-C30 子量表中有 7 个,29 个 EORTC QLQ-CR29 子量表中有 14 个。LARS 评分能够区分接受放疗的患者(p=0.0026)、TME 与 PME(p=0.0060)、肿瘤距肛门缘<10cm(p=0.0030)和有保护性造口史的患者(p<0.0001)。

结论

LARS 评分意大利版本是一种有效且可靠的工具,可用于评估意大利接受保肛手术治疗直肠癌患者的 LARS。

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