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妇科癌症患者临床试验和临床实践中生活质量测量的应用。

Application of quality-of-life measurements in clinical trials and in clinical practice for gynecologic cancer patients.

机构信息

Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria.

出版信息

Expert Rev Pharmacoecon Outcomes Res. 2010 Feb;10(1):63-71. doi: 10.1586/erp.09.76.

DOI:10.1586/erp.09.76
PMID:20157947
Abstract

Gynecologic cancer teams care for women with malignancies of the ovaries, fallopian tubes, uterus, cervix, vagina and vulva. Gynecologic cancer therapies have become increasingly tailored to individual risk factors and are frequently multimodal. Clinical trials are necessary to assess the effectiveness of new treatment regimes, and measurement of differences in impact on quality of life (QoL) has become as important as assessment of disease-free and overall survival. Site-specific gynecologic cancer QoL measurement tools have been developed to improve the sensitivity of QoL assessment and to capture a broad range of issues relevant to each specific cancer and treatment modality. QoL assessment tools must be valid, reliable and sensitive to measure the differences in QoL domains in the populations in which they are used, and their development must be methodologically sound and transparent in order that researchers can have confidence that the instruments are fit for purpose. With improving survival rates for most gynecologic malignancies, survivorship issues are becoming increasingly important, relating to all domains of QoL. Patient-reported outcome measures are becoming integral components of cancer follow-up pathways and survivorship programs, identifying physical, psychological or functional legacies that impact on QoL during the months and years following the completion of cancer treatment. Late effects that impact on sexual functioning are becoming especially important for cancers with effective treatment regimes affecting younger women. The development of valid outcome measures for assessment of sexual function for gynecologic cancer patients is a priority.

摘要

妇科癌症团队负责治疗患有卵巢、输卵管、子宫、宫颈、阴道和外阴恶性肿瘤的女性。妇科癌症的治疗方法越来越针对个体的危险因素,并且经常采用多模式治疗。需要进行临床试验来评估新治疗方案的有效性,并且对生活质量(QoL)影响的衡量变得与无病生存和总体生存的评估一样重要。已经开发了针对特定部位的妇科癌症 QoL 测量工具,以提高 QoL 评估的敏感性,并涵盖与每种特定癌症和治疗方式相关的广泛问题。QoL 评估工具必须具有有效性、可靠性和敏感性,以衡量其在使用人群中 QoL 领域的差异,并且其开发必须在方法学上合理且透明,以便研究人员能够相信这些工具符合目的。随着大多数妇科恶性肿瘤的生存率提高,生存问题变得越来越重要,涉及到 QoL 的所有领域。患者报告的结果测量正在成为癌症随访途径和生存计划的组成部分,确定在癌症治疗完成后的数月和数年内影响 QoL 的身体、心理或功能后遗症。对性功能有影响的晚期效应对于采用有效治疗方案影响年轻女性的癌症变得尤为重要。开发用于评估妇科癌症患者性功能的有效结局测量工具是当务之急。

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