Surgical Innovation and Evaluation 3 No surgical innovation without evaluation: the IDEAL recommendations
Surgical Innovation and Evaluation 3 No surgical innovation without evaluation: the IDEAL recommendations
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DOI：
10.1016/s0140-6736(09)61116-8
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发表时间：
2009-09-01
期刊：
影响因子：
168.9
通讯作者：
Nicholl, Jon
中科院分区：
文献类型：
--
作者：
McCulloch, Peter;Altman, Douglas G.;Nicholl, Jon
手术和其他侵入性治疗是复杂的干预措施，其评估受到取决于操作者、团队和环境的因素的挑战，例如学习曲线、质量变化和平衡感。我们提出的建议，评估手术的基础上的五个阶段的描述手术的发展过程。我们还鼓励广泛使用前瞻性数据库和登记处。新技术的报告应作为一项职业义务登记，如果结果是不利的，必要时可以匿名。病例系列研究应被前瞻性开发研究所取代，以便进行早期技术修改，并被前瞻性研究数据库所取代，以便进行后期试验前评价。这些研究的方案应公开登记。统计过程控制技术在早期和后期评估中都很有用。应尽可能使用随机试验来研究疗效，但充分的试验前数据对于计算功效、澄清干预的定义和适应症以及制定质量指标至关重要。进行随机临床试验的困难应该通过评估学习曲线和缓解平衡问题的措施来解决。当随机试验不可行时，应使用替代的前瞻性设计，如中断时间序列研究。应使用前瞻性数据库对既定程序进行监测，以分析结局变化并识别晚期和罕见事件。外科研究的改进设计、实施和报告的实现需要编辑、卫生保健和研究的资助者、监管机构和专业协会的协调行动。
Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.