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自体脂肪移植乳房的验证结局:VOGUE 研究。研究和审核的核心结局集的制定。

Validated Outcomes in the Grafting of Autologous Fat to the Breast: The VOGUE Study. Development of a Core Outcome Set for Research and Audit.

机构信息

East Grinstead, Birmingham, London, Liverpool, and Nottingham, United Kingdom; and Boston, Mass.

From the Department of Plastic Surgery, Queen Victoria Hospital NHS Foundation Trust; the Department of Plastic Surgery and Burns, Birmingham Children's Hospital; the Department of Plastic Surgery, Guy's and St. Thomas' NHS Foundation Trust; Barts and The London School of Medicine and Dentistry; the University of Liverpool; the University of Nottingham; the College of Medical and Dental Sciences, University of Birmingham; and the Division of Plastic Surgery, Brigham and Women's Hospital.

出版信息

Plast Reconstr Surg. 2018 May;141(5):633e-638e. doi: 10.1097/PRS.0000000000004273.

DOI:10.1097/PRS.0000000000004273
PMID:29697603
Abstract

BACKGROUND

Autologous fat grafting is an important part of the reconstructive surgeon's toolbox when treating women affected by breast cancer and subsequent tumor extirpation. The debate over safety and efficacy of autologous fat grafting continues within the literature. However, work performed by the authors' group has shown significant heterogeneity in outcome reporting. Core outcome sets have been shown to reduce heterogeneity in outcome reporting. The authors' goal was to develop a core outcome set for autologous fat grafting in breast reconstruction.

METHODS

The authors published their protocol a priori. A Delphi consensus exercise among key stakeholders was conducted using a list of outcomes generated from their previous work. These outcomes were divided into six domains: oncologic, clinical, aesthetic and functional, patient-reported, process, and radiologic.

RESULTS

In the first round, 55 of 78 participants (71 percent) completed the Delphi consensus exercise. Consensus was reached on nine of the 13 outcomes. The clarity of the results and lack of additional suggested outcomes deemed further rounds to be unnecessary.

CONCLUSIONS

The VOGUE Study has led to the development of a much-needed core outcome set in the active research front and clinical area of autologous fat grafting. The authors hope that clinicians will use this core outcome set to audit their practice, and that researchers will implement these outcomes in their study design and reporting of autologous fat grafting outcomes. The authors encourage journals and surgical societies to endorse and encourage use of this core outcome set to help refine the scientific quality of the debate, the discourse, and the literature.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

摘要

背景

自体脂肪移植是乳腺癌患者和随后肿瘤切除后重建外科医生工具箱中的重要组成部分。文献中仍在继续讨论自体脂肪移植的安全性和有效性。然而,作者小组的工作表明,结果报告的异质性很大。核心结局集已被证明可以减少结果报告的异质性。作者的目标是为乳腺癌重建中的自体脂肪移植制定一个核心结局集。

方法

作者事先公布了他们的方案。通过对来自他们以前工作的一系列结果进行分类,在关键利益相关者中进行了德尔菲共识研究。这些结果分为六个领域:肿瘤学、临床、美学和功能、患者报告、过程和影像学。

结果

在第一轮中,78 名参与者中有 55 名(71%)完成了德尔菲共识研究。就 13 项结果中的 9 项达成了共识。结果的清晰度和没有额外建议的结果使得不需要进行进一步的轮次。

结论

VOGUE 研究导致了自体脂肪移植这一活跃研究前沿和临床领域急需的核心结局集的发展。作者希望临床医生将使用这个核心结局集来审核他们的实践,研究人员将在他们的自体脂肪移植结果研究设计和报告中实施这些结果。作者鼓励期刊和外科协会支持和鼓励使用这个核心结局集,以帮助提高关于自体脂肪移植的科学质量的辩论、讨论和文献。

临床问题/证据水平:治疗,V。

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