Haase G M
Department of Pediatric Surgery, Children's Hospital, University of Colorado School of Medicine, Denver 90218.
Cancer. 1994 Nov 1;74(9 Suppl):2630-7. doi: 10.1002/1097-0142(19941101)74:9+<2630::aid-cncr2820741808>3.0.co;2-z.
Prospective clinical trials are used to evaluate therapeutic interventions. Because surgery is involved in the diagnosis, staging, and therapy of solid malignancies, active surgical leadership in these cancer studies is important. There are currently barriers to widespread surgical participation in clinical trials. This report defines the obstacles as well as documents efforts to overcome them and improve surgical quality assurance in cooperative group research. The surgical leadership of several clinical cooperative groups sponsored by the National Cancer Institute (NCI) were interviewed. Cooperative group reports were analyzed with respect to internal audits, quality assurance and activities of surgical monitoring committees. Minutes from meetings of the NCI's workshops on "Surgeons in Clinical Trials" were reviewed. Six concerns present impediments to surgical quality in clinical trials. To address these, substantive surgical leadership is being developed throughout the cooperative group system. Surgical co-principal investigators for institutions and protocols are being appointed. Uniform surgical standards and operative guidelines are being developed. Surgical data review occur at the local institution as well as through central audits and surgical monitoring committees. Coordinators in surgical data management are being trained. Surgical education is organized at cooperative group meetings and disseminated to the surgical community by seminars, workshops, audiovisual teaching sessions, and scientific publications. Surgeons are playing increasing leadership roles in the cancer trials performed by cooperative groups. Surgical leaders are dedicated to a broad-scale quality assurance effort. Enhanced surgical commitment, widespread clinical participation, and focused leadership should affect a high level of surgical quality care in clinical trials research.
前瞻性临床试验用于评估治疗性干预措施。由于手术涉及实体恶性肿瘤的诊断、分期和治疗，因此在这些癌症研究中积极发挥手术主导作用很重要。目前，手术广泛参与临床试验存在障碍。本报告定义了这些障碍，并记录了为克服这些障碍以及在合作组研究中提高手术质量保证所做的努力。对由美国国立癌症研究所（NCI）赞助的几个临床合作组的手术负责人进行了访谈。对合作组报告进行了关于内部审计、质量保证和手术监测委员会活动的分析。查阅了NCI“临床试验中的外科医生”研讨会会议记录。有六个问题对临床试验中的手术质量构成了障碍。为解决这些问题，正在整个合作组系统中发展实质性的手术领导作用。正在为各机构和方案任命外科共同主要研究者。正在制定统一的手术标准和操作指南。手术数据审查在当地机构进行，也通过中央审计和手术监测委员会进行。正在培训手术数据管理协调员。在合作组会议上组织手术教育，并通过研讨会、讲习班、视听教学课程和科学出版物传播给外科界。外科医生在合作组进行的癌症试验中发挥着越来越重要的领导作用。手术负责人致力于广泛的质量保证工作。加强手术投入、广泛的临床参与和有针对性的领导应能在临床试验研究中实现高水平的手术质量护理。
