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全踝关节置换术中不良事件报告的不一致性:文献系统评价

Inconsistency in the Reporting of Adverse Events in Total Ankle Arthroplasty: A Systematic Review of the Literature.

作者信息

Mercer Jeff, Penner Murray, Wing Kevin, Younger Alastair S E

机构信息

Department of Orthopaedics, University of British Columbia, Vancouver, British Columbia, Canada.

Department of Orthopaedics, University of British Columbia, Vancouver, British Columbia, Canada

出版信息

Foot Ankle Int. 2016 Feb;37(2):127-36. doi: 10.1177/1071100715609719. Epub 2015 Oct 7.

DOI:10.1177/1071100715609719
PMID:26445992
Abstract

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.

摘要

背景

许多外科亚专业都提出了并发症分类系统。本系统评价的目的是分析全踝关节置换术中用于识别并发症的不同术语的数量和频率。我们假设该术语会有很大差异,这支持了对标准化报告系统的需求。

方法

分析符合预定义纳入/排除标准的研究,以确定用于描述不良事件的术语。然后将所有术语列表,并就所有纳入研究中使用的多样性和频率进行量化。术语还被分为10类,并计算每个不良事件的报告发生次数。然后开发了一个报告工具。

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)仅在一项研究中使用。报告最频繁的类别是翻修手术,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

全踝关节置换术并发症和不良结局的报告差异很大。这种缺乏一致性阻碍了为终末期踝关节关节炎制定连贯的、基于证据的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。本研究提出了一个用于不良事件标准化评估和报告的原型工作表。

证据水平

三级,决策分析,对三级及以上研究的系统评价。

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