本研究旨在确定FACT肝胆（FACT-Hep）问卷的最小临床重要差异（MCID），以便对胰腺癌（PC）患者接受放射治疗（RT）对生活质量（QOL）的影响进行有意义的评估。研究对象包括接受放射治疗作为治疗目的的PC患者，他们在基线和治疗结束时（EOT）完成了FACT-Hep问卷调查。使用锚定法和分布法确定了FACT-Hep和子域的MCID。在锚定法中，利用PROMIS-10的整体健康评估项目作为参考值，定义了得分变化的改善和恶化的年龄调整回归模型。基于分布分析，MCID的计算值为0.3和0.5个标准差（SD）。MCID的点估计值使用0.5 SD（范围），并在时间点和方法上求平均，范围通过方法间的最小和最大值来报告。MCID最低的FACT-Hep子域为情感域（恶化为0.8-1.8）。肝胆癌亚分表（HCS）具有最高和最宽的MCID范围。HCS得分的2.9-4.3的积极变化应被视为临床相关的改善。使用0.3 SD的MCID估计与锚定法估计值在身体领域（1.6-2.4）完全一致。Fact-Hep总分的MCID范围为6.9-10.5，改善和恶化的范围分别为6.5-10.5。使用锚定法和分布法相结合计算了FACT-Hep子域和总分的MCID。这些发现对于确定接受RT治疗的PC患者的QOL是否有意义的改善或恶化至关重要。建议在评估社交领域的MCID时使用不同的参考值。© 2023版权归Elsevier Inc所有。

This study aimed to define the minimal clinically important difference (MCID) for the FACT Hepatobiliary (FACT-Hep) questionnaire, allowing meaningful evaluation of the effect of radiotherapy (RT) on quality of life (QOL) in patients treated for pancreatic cancer (PC).The cohort included patients with PC who received RT as a component of curative intent therapy, who completed the FACT-Hep at baseline and end of treatment (EOT). The MCID was determined for the FACT-Hep and subdomains using anchor-based and distribution-based approaches. In the anchor-based approach, improvement and deterioration in age-adjusted regression models for change in scores were defined using the overall health assessment item of the PROMIS-10 as the anchor. The MCID was calculated as 0.3 and 0.5 standard deviation (SD) for distribution-based analysis. MCID point estimate using 0.5 SD (range) was averaged across time points and by approach, and the ranges are reported as minimum and maximum values across methods.The FACT-Hep domain with the lowest MCID was the emotional domain (deterioration 0.8-1.8). The hepatobiliary cancer subscale (HCS) has the highest and widest MCID range. A positive change of 2.9-4.3 in HCS should be considered a clinically relevant improvement. MCID estimates from 0.3 SD were in exact agreement with the anchor-based estimates for the physical domain (1.6-2.4). The MCID range for the Fact-Hep total score was 6.9-10.5 and 6.5-10.5 for improvement and deterioration, respectively.The MCID for the FACT-Hep subdomains and totals were calculated using a combination of anchor- and distribution-based approaches. These findings are fundamental to determine whether there is meaningful improvement or deterioration in QOL for patients with PC receiving RT. Evaluating a different anchor for determining the MCID of the social domain is recommended.Copyright © 2023. Published by Elsevier Inc.