“法国 LARS 评分”：验证低前切除综合征（LARS）评分的法国版本，用于测量直肠癌患者保肛手术后的肠道功能障碍：研究方案。
'French LARS score': validation of the French version of the low anterior resection syndrome (LARS) score for measuring bowel dysfunction after sphincter-preserving surgery among rectal cancer patients: a study protocol.
机构信息
Department of digestive surgery, University Hospital of Caen, Caen, France
ANTICIPE" U1086 INSERM-University of Caen Normandy, Team « Ligue contre le Cancer », Centre François Baclesse, Caen, France.
出版信息
BMJ Open. 2020 Mar 8;10(3):e034251. doi: 10.1136/bmjopen-2019-034251.
INTRODUCTION
Many bowel problems following low anterior resection (LAR) for rectal cancer considerably impair the quality of life (QoL) of patients. The LAR syndrome (LARS) scale is a self-report questionnaire to identify and assess bowel dysfunction after rectal cancer surgery. It has been translated and validated in several languages but not in French (metropolitan French). The primary objective is to adapt the LARS scale to the French language (called French-LARS score) and to assess its psychometric properties. Secondary objectives are to assess both the prevalence and severity of LARS and to measure their impact on QoL.
METHODS AND ANALYSIS
A French multicentre observational cohort study has been designed. The validation study will include translation of the LARS scale following the current international recommendations, assessment of its reliability, convergent and discriminant validities, sensitivity, internal consistency, internal validity and confirmatory analyses. One thousand patients will be enrolled for the analyses. The questionnaire will be initially administered to the first 100 patients to verify the adequacy and degree of comprehension of the questions. Then reproducibility will be investigated by a test-retest procedure in the following 400 patients.An analysis will be conducted to determine the correlation between the LARS score and the Quality of Life Questionnaire (QLQ; European Organization for Treatment and Research of Cancer's QLQ-C30, QLQ-CR29). Risk factors linked to QoL deterioration will be identified and their impact will be measured. This study will meet the need for a validated tool to improve patient care and QoL.
ETHICS AND DISSEMINATION
The institutional review board of the University Hospital of Caen and the ethics committee (CPP Nord Ouest I, 25 January 2019) approved the study.
TRIAL REGISTRATION NUMBER
NCT03569488.
介绍
许多直肠癌低位前切除术（LAR）后的肠问题极大地影响了患者的生活质量（QoL）。LAR 综合征（LARS）量表是一种自我报告问卷，用于识别和评估直肠癌手术后的肠功能障碍。它已被翻译成多种语言并进行了验证，但尚未在法语（法国本土法语）中进行验证。主要目的是将 LARS 量表改编为法语（称为 French-LARS 评分），并评估其心理测量特性。次要目标是评估 LARS 的发生率和严重程度，并测量其对 QoL 的影响。
方法和分析
设计了一项法国多中心观察性队列研究。验证研究将包括根据当前国际建议翻译 LARS 量表，评估其可靠性、收敛和判别有效性、敏感性、内部一致性、内部有效性和验证性分析。将招募 1000 名患者进行分析。该问卷将首先对前 100 名患者进行评估，以验证问题的充分性和理解程度。然后，在接下来的 400 名患者中通过测试-重测程序来研究可重复性。将进行分析以确定 LARS 评分与生活质量问卷（欧洲癌症治疗与研究组织的 QLQ-C30、QLQ-CR29）之间的相关性。将确定与 QoL 恶化相关的风险因素，并测量其影响。本研究将满足对经过验证的工具的需求，以改善患者的护理和 QoL。
伦理和传播
卡昂大学医院的机构审查委员会和伦理委员会（CPP Nord Ouest I，2019 年 1 月 25 日）批准了该研究。
试验注册编号
NCT03569488。
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