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中德荷前列腺癌患者机器人辅助根治性前列腺切除术后生活质量的差异:对国际多中心随机对照试验的启示。

Differences in Quality of Life between German and Dutch Patients with Prostate Cancer Treated with Robot-assisted Radical Prostatectomy: Implications for International Multicenter Randomized Controlled Trials.

机构信息

Prostate Center Northwest, Department of Urology, Paediatric Urology and Urooncology, St. Antonius-Hospital, Gronau, Germany.

Department of Psychosomatic Medicine, Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

出版信息

Eur Urol Focus. 2024 May;10(3):454-460. doi: 10.1016/j.euf.2023.02.007. Epub 2023 Feb 28.

DOI:10.1016/j.euf.2023.02.007
PMID:36863963
Abstract

BACKGROUND

As a local treatment for prostate cancer (PCa), robot-assisted radical prostatectomy (RARP) may have a quality of life (QoL) benefit over open surgery. Recent analyses revealed substantial between-country differences in the function and symptom scale scores for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), which is typically used to assess patient-reported QoL. Such differences could have implications for multinational studies in PCa.

OBJECTIVE

To examine whether nationality is significantly associated with patient-reported QoL.

DESIGN, SETTING, AND PARTICIPANTS: The study cohort comprised Dutch and German patients with PCa treated with RARP in a single high-volume prostate center from 2006 to 2018. Analyses were restricted to patients who were preoperatively continent with at least one follow-up time point.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

QoL was measured in terms of the global Quality of Life (QL) scale score and the overall summary score for the EORTC QLQ-C30. Linear mixed models for repeated-measures multivariable analyses (MVAs) were used to examine the association between nationality and both the global QL score and the summary score. MVAs were further adjusted for QLQ-C30 baseline values, age, Charlson comorbidity index, preoperative prostate-specific antigen, surgical expertise, pathological tumor and nodal stage, Gleason grade, degree of nerve-sparing, surgical margin status, 30-d Clavien-Dindo grade complications, urinary continence recovery, and biochemical recurrence/postoperative radiotherapy.

RESULTS AND LIMITATIONS

For Dutch (n = 1938) versus German (n = 6410) men, the mean baseline scores were 82.8 versus 71.9 for the global QL scale score and 93.4 versus 89.7 for the QLQ-C30 summary score. Urinary continence recovery (QL: +8.9, 95% confidence interval [CI] 8.1-9.8; p < 0001) and Dutch nationality (QL: +6.9, 95% CI 6.1-7.6; p < 0001) were the strongest positive contributors to the global QL and summary scores, respectively. The main limitation is the retrospective study design. In addition, our Dutch cohort may not be representative of the general Dutch population and reporting bias cannot be ruled out.

CONCLUSIONS

Our findings provide observational evidence under specific conditions involving the same setting for patients of two different nationalities suggesting that cross-national patient-reported QoL differences appear to be real and may need to be taken into consideration in multinational studies.

PATIENT SUMMARY

We observed differences in the quality-of-life scores reported by Dutch and German patients with prostate cancer after they underwent robot-assisted removal of the prostate. These findings should be taken into consideration in cross-national studies.

摘要

背景

作为前列腺癌(PCa)的局部治疗方法,机器人辅助根治性前列腺切除术(RARP)可能比开放手术具有更高的生活质量(QoL)获益。最近的分析显示,欧洲癌症研究与治疗组织(EORTC)生活质量问卷核心 30 项(EORTC QLQ-C30)的功能和症状量表评分在国家之间存在显著差异,该问卷通常用于评估患者报告的 QoL。这些差异可能对 PCa 的跨国研究产生影响。

目的

研究国籍是否与患者报告的 QoL 显著相关。

设计、地点和参与者:该研究队列包括 2006 年至 2018 年间在一个高容量前列腺中心接受 RARP 治疗的荷兰和德国 PCa 患者。分析仅限于术前有控尿功能且至少有一个随访时间点的患者。

结局测量和统计分析

采用全球生活质量(QL)量表评分和 EORTC QLQ-C30 总评分来衡量 QoL。采用重复测量多变量分析(MVAs)的线性混合模型来研究国籍与全球 QL 评分和总评分之间的关系。MVAs 进一步调整了 QLQ-C30 的基线值、年龄、Charlson 合并症指数、术前前列腺特异性抗原、手术经验、病理肿瘤和淋巴结分期、Gleason 分级、神经保留程度、手术切缘状态、30 天 Clavien-Dindo 分级并发症、尿控恢复和生化复发/术后放疗。

结果和局限性

对于荷兰(n=1938)和德国(n=6410)男性,全球 QL 量表评分的基线平均评分分别为 82.8 和 71.9,QLQ-C30 总评分分别为 93.4 和 89.7。尿控恢复(QL:+8.9,95%置信区间[CI] 8.1-9.8;p<0001)和荷兰国籍(QL:+6.9,95%CI 6.1-7.6;p<0001)是全球 QL 和总评分的最强正贡献因素。主要限制是回顾性研究设计。此外,我们的荷兰队列可能无法代表一般荷兰人群,并且不能排除报告偏倚。

结论

在涉及具有相同环境的两种不同国籍患者的特定条件下,我们的发现提供了观察性证据,表明跨国患者报告的 QoL 差异似乎是真实存在的,在跨国研究中需要考虑这些差异。

患者总结

我们观察到接受机器人辅助前列腺切除术的荷兰和德国前列腺癌患者的生活质量评分存在差异。在跨国研究中应考虑这些发现。

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