头颈癌研究的结果工具箱
Outcomes toolbox for head and neck cancer research.
作者信息
Ringash Jolie, Bernstein Lori J, Cella David, Logemann Jerilynn, Movsas Benjamin, Murphy Barbara, Trotti Andrea, Wells Nancy, Yueh Bevan, Ridge John
机构信息
Department of Radiation Oncology and Institute of Health Policy, Management and Evaluation, The Princess Margaret Cancer Centre and The University of Toronto, Toronto, Canada.
出版信息
Head Neck. 2015 Mar;37(3):425-39. doi: 10.1002/hed.23561. Epub 2015 Jan 22.
BACKGROUND
Clinical research in head and neck cancer traditionally focused on tumor control. As survival improves, it is increasingly recognized that the side-effects of multimodality treatment can be profound and enduring. Thus, clinical trials require patient-reported and functional outcomes.
METHODS
A subcommittee of the Previously Untreated, Locally Advanced (PULA) Task Force of the Head and Neck Steering Committee of the Coordinating Centre for Clinical Trials at the National Cancer Institute (NCI) was convened to identify a set of instruments suitable for widespread application in the conduct of clinical trials for head and neck cancer.
RESULTS
Based on existing literature and expert opinion, 18 main areas of concern were identified. For each, measures suitable for use in multicenter clinical trials were recommended on the basis of validity, feasibility, and clinical acceptance.
CONCLUSION
Suitable instruments exist for most head and neck cancer concerns, but gaps require further development. Future efforts should be made to harmonize measurement across trials.
背景
头颈部癌症的临床研究传统上侧重于肿瘤控制。随着生存率的提高，人们越来越认识到多模式治疗的副作用可能是严重且持久的。因此，临床试验需要患者报告的结果和功能结局。
方法
美国国立癌症研究所（NCI）临床试验协调中心头颈指导委员会先前未治疗的局部晚期（PULA）工作组的一个小组委员会召开会议，以确定一套适合在头颈部癌症临床试验中广泛应用的工具。
结果
基于现有文献和专家意见，确定了18个主要关注领域。对于每个领域，根据有效性、可行性和临床可接受性，推荐了适用于多中心临床试验的测量方法。
结论
对于大多数头颈部癌症相关问题，都有合适的工具，但仍存在差距需要进一步开发。未来应努力使各试验的测量方法统一。
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