Medical School, University of Minnesota, Minneapolis, MN, USA.
Department of Urology, University of Minnesota, Minneapolis, MN, USA.
BJU Int. 2019 Jun;123(6):1078-1085. doi: 10.1111/bju.14676. Epub 2019 Feb 27.
To assess uptake and application of the IDEAL principles in original surgical procedure- or device-related clinical research studies, as well as its reported relevance as characterized by secondary publications, editorials and reviews.
IDEAL (Idea, Development, Exploration, Assessment, Long-term study) is a framework that provides stage-specific guidance for surgical innovation and represented a major advance towards raising evidential standards. We performed a comprehensive literature search of all urology-related publications citing one or more of seven key publications on IDEAL in The Lancet and BMJ using multiple databases up to 31 December 2017.
We identified a total of 150 urology-related manuscripts citing IDEAL, of which 83 (55.3%) were original research and 67 (44.7%) were secondary publications. Among the original research articles, 40 (48.2%) did not explicitly apply IDEAL principles or were not surgical innovation studies. The IDEAL phases of the 43 (51.8%) remaining original research studies were IDEAL, in nine (20.9%), 27 (62.8%), four (9.3%), 0 (0%), and three publications (7.0%), respectively. Across IDEAL stages, 30 (75.0%) studies were prospective, 29 (85.3%) reported ethical oversight, and 39 (90.7%) captured treatment-related harms. None of the studies collected information on physician experience.
The IDEAL framework has found widespread adoption in the urology literature as witnessed by a large number of original manuscripts and secondary publications citing IDEAL; however, its application is largely limited to the early stages of surgical innovation, frequently with inappropriate and incomplete implementation. Further efforts are needed to guide investigators in the optimal use of the IDEAL framework as it relates to surgical innovation in urology.
评估 IDEAL 原则在原创手术相关或器械相关临床研究中的应用情况,以及其通过二次出版物、社论和评论来体现的相关性。
IDEAL(理念、发展、探索、评估、长期研究)是一个为外科创新提供特定阶段指导的框架,是提高证据标准的重大进展。我们使用多个数据库,对在《柳叶刀》和《英国医学杂志》上发表的涉及 IDEAL 的七篇关键出版物之一或多篇出版物的所有泌尿外科相关文献进行了全面的文献检索,检索时间截至 2017 年 12 月 31 日。
我们共确定了 150 篇引用 IDEAL 的泌尿外科相关手稿,其中 83 篇(55.3%)为原创研究,67 篇(44.7%)为二次出版物。在原创研究文章中,40 篇(48.2%)没有明确应用 IDEAL 原则或不是外科创新研究。其余 43 篇(51.8%)原创研究的 IDEAL 阶段分别为 IDEAL、9 篇(20.9%)、27 篇(62.8%)、4 篇(9.3%)、0 篇(0%)和 3 篇(7.0%)。在 IDEAL 各个阶段,30 篇(75.0%)研究为前瞻性研究,29 篇(85.3%)报告了伦理监督,39 篇(90.7%)记录了治疗相关的危害。没有研究收集关于医生经验的信息。
IDEAL 框架在泌尿外科文献中得到了广泛应用,这可以从大量引用 IDEAL 的原始手稿和二次出版物中看出;然而,其应用主要局限于外科创新的早期阶段,通常实施不恰当且不完整。需要进一步努力指导研究人员最佳使用 IDEAL 框架,以促进泌尿外科的外科创新。