McAlpine Jessica N, Greimel Elfriede, Brotto Lori A, Nout Remy A, Shash Emad, Avall-Lundqvist Elisabeth, Friedlander Michael L, Joly Florence
*Department of Gynecology and Obstetrics, University of British Columbia, Vancouver, British Columbia, Canada; †Department of Medical Psychology and Psychotherapy, Medical University of Graz, Graz, Austria; ‡Department of Clinical Oncology, Leiden UniversityMedical Center, Leiden, the Netherlands; §EORTC, Brussels, Belgium; ∥Department of Gynecologic Oncology, Karolinska University Hospital, Stockholm, Sweden; ¶Department of Medical Oncology, The Prince of Wales Hospital, University of New South Wales Clinical School, Sydney, Australia; and #Departments of Medical Oncology and Clinical Research, Centre Francois Baclesse, CHU Côte de Nacre, University of Basse Normandie, Caen, France.
Int J Gynecol Cancer. 2014 Nov;24(9):1686-92. doi: 10.1097/IGC.0000000000000245.
Quality of life (QoL) in endometrial cancer (EC) is understudied. Incorporation of QoL questionnaires and patient-reported outcomes in clinical trials has been inconsistent, and the tools and interpretation of these measures are unfamiliar to most practitioners. In 2012, the Gynecologic Cancer InterGroup Symptom Benefit Working Group convened for a brainstorming collaborative session to address deficiencies and work toward improving the quality and quantity of QoL research in women with EC.
Through literature review and international expert contributions, we compiled a comprehensive appraisal of current generic and disease site-specific QoL assessment tools, strengths and weaknesses of these measures, assessment of sexual health, statistical considerations, and an exploration of the unique array of histopathologic and clinical factors that may influence QoL outcomes in women with EC.
This collaborative composition is the first publication specific to EC that addresses methodology in QoL research and the components necessary to achieve high quality QoL data in clinical trials. Future recommendations regarding (1) the incorporation of patient-reported outcomes in all clinical trials in EC, (2) definition of an a priori hypothesis, (3) utilization of validated tools and consideration of new tools corresponding to new therapies or specific symptoms, (4) publication within the same time frame as clinical outcome data, and (5) attempt to correct for disease site-specific potential confounders are presented.
Improved understanding of methodology in QoL research and an increased undertaking of EC-specific QoL research in clinical trials are imperative if we are to improve outcomes in women with EC.
子宫内膜癌（EC）患者的生活质量（QoL）研究不足。在临床试验中纳入生活质量问卷和患者报告结局的情况并不一致，大多数从业者对这些测量工具及其解读并不熟悉。2012年，妇科癌症国际协作组症状获益工作组召开了一次头脑风暴协作会议，以解决不足之处，并努力提高EC女性生活质量研究的质量和数量。
通过文献综述和国际专家的贡献，我们对当前通用的和疾病部位特异性的生活质量评估工具、这些测量方法的优缺点、性健康评估、统计学考量以及对可能影响EC女性生活质量结局的一系列独特的组织病理学和临床因素进行了全面评估。
这一协作成果是第一篇专门针对EC的出版物，阐述了生活质量研究的方法以及在临床试验中获得高质量生活质量数据所需的组成部分。提出了未来的建议，包括（1）在所有EC临床试验中纳入患者报告结局；（2）定义先验假设；（3）使用经过验证的工具，并考虑与新疗法或特定症状相对应的新工具；（4）与临床结局数据在同一时间框架内发表；（5）尝试校正疾病部位特异性的潜在混杂因素。
如果我们要改善EC女性的结局，就必须更好地理解生活质量研究的方法，并在临床试验中增加针对EC的生活质量研究。
