Inconsistency in the Reporting of Adverse Events in Total Ankle Arthroplasty: A Systematic Review of the Literature
Inconsistency in the Reporting of Adverse Events in Total Ankle Arthroplasty: A Systematic Review of the Literature
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DOI：
10.1177/1071100715609719
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发表时间：
2016-02-01
影响因子：
2.7
通讯作者：
Younger, Alastair S. E.
中科院分区：
文献类型：
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作者：
Mercer, Jeff;Penner, Murray;Younger, Alastair S. E.
背景：许多外科专科都提出了并发症分类系统。本系统综述的目的是分析用于识别全踝关节置换术并发症的不同术语的数量和频率。我们假设，这个术语将是高度可变的，支持需要一个标准化的系统reporting.Methods：符合预定义的纳入/排除标准的研究进行了分析，以确定用于描述不良事件的术语。然后将所有术语列表并量化所有纳入研究的多样性和使用频率。还将术语分为10类，并计算每种不良事件的报告发生次数。结果：在117项研究中用于描述不良结局的572个独特术语中，55.9%（320/572）仅用于单一研究。最常报告的类别是翻修手术，86%的论文使用115个不同术语报告了该事件。其他类别包括额外的非翻修手术（74%的论文，93个术语），松动/骨质溶解（63%的论文，86个术语），骨折（60%的论文，53个术语），伤口问题（52%的论文，27个术语），感染（52%的论文，27个术语），植入物问题（50%的论文，57个术语），软组织损伤（31%的论文，30个术语），异位骨化（22%的论文，17个术语），和疼痛（18%的论文，11个术语）。结论：全踝关节置换术的并发症和不良结局的报告是高度可变的。这种缺乏一致性的情况阻碍了对终末期踝关节炎制定有凝聚力的循证治疗指南所需数据的准确报告和解释。迫切需要标准化的报告工具。本研究提供了一个标准化评估和不良事件报告的原型工作表。证据等级：III级，决策分析，III级研究及以上的系统评价。
Background: Systems for classifying complications have been proposed for many surgical subspecialties. The goal of this systematic review was to analyze the number and frequency of different terms used to identify complications in total ankle arthroplasty. We hypothesized that this terminology would be highly variable, supporting a need for a standardized system of reporting.Methods: Studies that met predefined inclusion/exclusion criteria were analyzed to identify terminology used to describe adverse events. All terms were then tabulated and quantified with regard to diversity and frequency of use across all included studies. Terms were also grouped into 10 categories, and the number of reported occurrences of each adverse event was calculated. A reporting tool was then developed.Results: Of 572 unique terms used to describe adverse outcomes in 117 studies, 55.9% (320/572) were used in only a single study. The category that was most frequently reported was revision surgery, with 86% of papers reporting on this event using 115 different terms. Other categories included additional non-revision surgeries (74% of papers, 93 terms), loosening/osteolysis (63% of papers, 86 terms), fractures (60% of papers, 53 terms), wound problems (52% of papers, 27 terms), infection (52% of papers, 27 terms), implant problems (50% of papers, 57 terms), soft tissue injuries (31% of papers, 30 terms), heterotopic ossification (22% of papers, 17 terms), and pain (18% of papers, 11 terms).Conclusion: The reporting of complications and adverse outcomes for total ankle arthroplasty was highly variable. This lack of consistency impedes the accurate reporting and interpretation of data required for the development of cohesive, evidence-based treatment guidelines for end-stage ankle arthritis. Standardized reporting tools are urgently needed. This study presents a prototype worksheet for the standardized assessment and reporting of adverse events.Level of Evidence: Level-III, decision analyses, systematic review of Level III studies and above.