Michael Nicole, Palmer Claire, Smith John T, Pan Zhaoxing, St Hilaire Tricia, Morgan Jessica, Heagy Victoria, Garg Sumeet
Children's Hospital Colorado.
Department of Pediatrics, University of Colorado, School of Medicine.
J Pediatr Orthop. 2018 Apr;38(4):e190-e193. doi: 10.1097/BPO.0000000000001130.
Growth-friendly surgery has high complication rates. The Complication Severity Score for growth-friendly surgery was developed to maintain consistency while reporting complications as part of research in this rapidly evolving field. This study evaluates the interrater and intrarater reliability of this complication classification system.
After Institutional Review Board approval, complications during treatment for early onset scoliosis were identified from a prospectively collected database. Previous validation studies and a 10-case pilot survey determined that 60 cases were needed to represent a minimum of substantial agreement. In total, 63 of 496 cases were selected randomly to evenly represent each severity classification. The cases comprised an internet survey for classification sent to faculty and research coordinators involved in early onset scoliosis research, 3 weeks apart, with questions shuffled between iterations. Fleiss Kappa and Cohen Kappa were used to assess interrater and intrarater agreement, respectively.
A total of 20 participants, 12 faculty and 8 research assistants, completed the survey twice. The overall Fleiss Kappa coefficient for interrater agreement from the second round of the survey was 0.86 (95% confidence interval, 0.86-87), which represents substantial agreement. Reviewers agreed almost perfectly on categorizing complications as Device I (0.85), Disease I (0.91), Disease II (0.94), Device IIB (0.92), and Disease IV (0.98). There was substantial agreement for categorizing Device IIA (0.73) and Device III (0.76) complications. Disease III and Device IV were not evaluated in this survey since none of these occurred in the database. There was almost perfect intrarater agreement among faculty (0.87), research coordinators (0.85), and overall (0.86).
There is strong interrater and intrarater agreement for the published complications classification scheme for growing spine surgery. The complication classification system is a reliable tool for standardizing reports of complications with growth-friendly surgery. Adoption of this classification when reporting on growth-friendly surgery is recommended to allow for comparison of complications between treatment modalities.
Level I-diagnostic study.
有利于生长的手术并发症发生率较高。为在这个快速发展的领域进行研究时报告并发症保持一致性,制定了有利于生长的手术并发症严重程度评分系统。本研究评估该并发症分类系统的评分者间信度和评分者内信度。
经机构审查委员会批准后,从前瞻性收集的数据库中确定早发性脊柱侧弯治疗期间的并发症。先前的验证研究和一项10例病例的试点调查确定,需要60例病例才能代表至少实质性的一致性。总共从496例病例中随机选择63例,以均匀代表每个严重程度分类。这些病例包括一项用于分类的网络调查,分3周发送给参与早发性脊柱侧弯研究的教员和研究协调员,每次迭代之间问题打乱顺序。分别使用Fleiss Kappa和Cohen Kappa来评估评分者间和评分者内的一致性。
共有20名参与者,12名教员和8名研究助理,完成了两次调查。第二轮调查中评分者间一致性的总体Fleiss Kappa系数为0.86(95%置信区间,0.86 - 87),这代表实质性的一致性。评审者在将并发症分类为器械I(0.85)、疾病I(0.91)、疾病II(0.94)、器械IIB(0.92)和疾病IV(0.98)方面几乎完全一致。在对器械IIA(0.73)和器械III(0.76)并发症进行分类方面存在实质性的一致性。由于数据库中未出现疾病III和器械IV,因此本调查未对其进行评估。教员(0.87)、研究协调员(0.85)和总体(0.86)的评分者内一致性几乎完美。
对于已发表的生长性脊柱手术并发症分类方案,评分者间和评分者内具有很强的一致性。该并发症分类系统是标准化有利于生长的手术并发症报告的可靠工具。建议在报告有利于生长的手术时采用此分类,以便比较不同治疗方式之间的并发症情况。
I级 - 诊断性研究。