Glasbey J C, Magill E L, Brock K, Bach S P
Academic Department of Surgery, University of Birmingham, Birmingham, UK; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Clin Oncol (R Coll Radiol). 2017 Dec;29(12):799-810. doi: 10.1016/j.clon.2017.10.002. Epub 2017 Oct 31.
Trials of surgical procedures in the treatment of malignant disease face a unique set of challenges. This review aimed to describe recommendations for the design, delivery and reporting of randomised trials in surgical oncology. A literature search was carried out without date limits to identify articles related to trial methodology research in surgery and surgical oncology. A narrative review was framed around two open National Institute of Health Research portfolio trials in colon and rectal cancer: the STAR-TREC trial (ISRCTN14240288) and the ROCCS trial (ISRCTN46330337). Twelve specific challenges were highlighted: standardisation of technique; pilot and feasibility studies; balancing treatments; the recruitment pathway; outcome measures; patient and public representation; trainee-led networks; randomisation; novel techniques and training; learning curves; blinding; follow-up. Evidence-based recommendations were made for the future design and conduct of surgical oncology trials. Better understanding of the challenges facing trials in the surgical treatment of cancer will accelerate high-quality evaluation and rapid adoption of innovation for the benefit of patient care.
恶性疾病外科治疗的试验面临着一系列独特的挑战。本综述旨在描述外科肿瘤学随机试验的设计、实施和报告建议。进行了不限日期的文献检索，以识别与外科手术和外科肿瘤学试验方法研究相关的文章。围绕两项公开的英国国家卫生研究院投资组合试验——结肠癌和直肠癌的STAR-TREC试验（ISRCTN14240288）和ROCCS试验（ISRCTN46330337）进行了叙述性综述。突出了十二个具体挑战：技术标准化；试点和可行性研究；治疗平衡；招募途径；结局指标；患者和公众参与；由实习医生主导的网络；随机化；新技术和培训；学习曲线；盲法；随访。为未来外科肿瘤学试验的设计和实施提出了基于证据的建议。更好地理解癌症外科治疗试验所面临的挑战，将加速高质量评估，并为了患者护理的利益而迅速采用创新方法。
