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国际德尔菲共识过程定义的肱骨近端骨折治疗不良事件核心集。

Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process.

机构信息

Research and Development (L.A. and H.D) and Shoulder and Elbow, Surgery (L.A. and F.M.), Schulthess Clinic, Zurich, Switzerland.

Department of Orthopedic Surgery and Traumatology, University Hospital of Basel, Basel, Switzerland.

出版信息

BMC Musculoskelet Disord. 2021 Nov 30;22(1):1002. doi: 10.1186/s12891-021-04887-1.

DOI:10.1186/s12891-021-04887-1
PMID:34847888
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8630858/
Abstract

BACKGROUND

Proximal humerus fracture (PHF) complications, whether following surgery or nonoperative management, require standardization of definitions and documentation for consistent reporting. We aimed to define an international consensus core event set (CES) of clinically-relevant unfavorable events of PHF to be documented in clinical routine practice and research.

METHODS

A Delphi exercise was implemented with an international panel of experienced shoulder trauma surgeons selected by survey invitation of AO Trauma members. An organized list of PHF events after nonoperative or operative management was developed and reviewed by panel members using on-line surveys. The proposed core set was revised regarding event groups along with definitions, specifications and timing of occurrence. Consensus was reached with at least a two-third agreement.

RESULTS

The PHF consensus panel was composed of 231 clinicians worldwide who responded to at least one of two completed surveys. There was 93% final agreement about three intraoperative local event groups (device, osteochondral, soft tissue). Postoperative or nonoperative event terms and definitions organized into eight groups (device, osteochondral, shoulder instability, fracture-related infection, peripheral neurological, vascular, superficial soft tissue, deep soft tissue) were approved with 96 to 98% agreement. The time period for documentation ranged from 30 days to 24 months after PHF treatment depending on the event group and specification. The resulting consensus was presented on a paper-based PHF CES documentation form.

CONCLUSIONS

International consensus was achieved on a core set of local unfavorable events of PHF to foster standardization of complication reporting in clinical research and register documentation.

TRIAL REGISTRATION

Not applicable.

摘要

背景

肱骨近端骨折(PHF)并发症,无论是手术后还是非手术治疗后,都需要对定义和记录进行标准化,以便进行一致的报告。我们旨在定义一个国际共识核心事件集(CES),以记录 PHF 的临床相关不良事件,以便在临床常规实践和研究中使用。

方法

采用德尔菲法(Delphi),通过对 AO 创伤成员的调查邀请,选择了一组具有丰富肩部创伤外科经验的国际专家小组。制定了一份经手术或非手术治疗后 PHF 事件的列表,并由小组成员使用在线调查进行审查。根据事件组以及定义、规范和发生时间,对拟议的核心集进行修订。至少有三分之二的人达成一致意见。

结果

PHF 共识小组由全球 231 名临床医生组成,他们至少对完成的两次调查中的一次做出了回应。有 93%的最终共识是关于三种术中局部事件组(器械、骨软骨、软组织)。将术后或非手术的事件术语和定义组织成八个组(器械、骨软骨、肩关节不稳定、骨折相关感染、周围神经病变、血管、浅表软组织、深部软组织),得到了 96%至 98%的同意。文档记录的时间范围根据事件组和规范,从 PHF 治疗后 30 天到 24 个月不等。最终的共识以纸质的 PHF CES 文档形式呈现。

结论

国际上就 PHF 的局部不良事件核心集达成了共识,以促进临床研究和注册文档中并发症报告的标准化。

试验注册

不适用。

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