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全球成年非黑素瘤皮肤癌患者手术不完全切除的发生率:一项观察性研究的系统评价和荟萃分析研究方案。

Global incidence of incomplete surgical excision in adult patients with non-melanoma skin cancer: study protocol for a systematic review and meta-analysis of observational studies.

机构信息

Division of Surgery and Interventional Science, University College London, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.

Whiston Hospital, St Helens and Knowsley Teaching Hospitals NHS Trust, Warrington Road, Prescot, Merseyside, L35 5DR, UK.

出版信息

Syst Rev. 2020 Apr 17;9(1):83. doi: 10.1186/s13643-020-01350-5.

Abstract

BACKGROUND

Non-melanoma skin cancer, which includes basal cell carcinoma and cutaneous squamous cell carcinoma, is the commonest malignancy worldwide. The mainstay of treatment is surgical excision. Despite this being an exceptionally common procedure, it is not known what the accepted standard is for incomplete excision. Multiple single-centre, regional and national studies have previously reported their incidence of incomplete excision in isolation. Furthermore, is it not known what effect potential risk factors such as the operating group, location of lesions, type of reconstruction, histological components or use of loupe magnification have on the incidence of incomplete excisions. The objective of this study will be to systematically evaluate observational data that present incidence of incomplete surgical excision amongst adult patients with non-melanoma skin cancer worldwide.

METHODS

We designed and registered a study protocol for a systematic review and meta-analysis of descriptive epidemiology data. A comprehensive literature search will be conducted (from January 2000 onwards) in MEDLINE, EMBASE, Scopus, CINAHL, EMCare and Cochrane Library. Grey literature will be identified through searching Open Grey, dissertation databases (e.g. Open Access Theses and Dissertations) and clinical trial registers (e.g. WHO ICTRP). Observational studies (cohort, cross-sectional, case series and clinical audits) reporting the incidence of incomplete surgical excision and conducted in adult patients with non-melanoma skin cancer will be included. The primary outcome will be the incidence of incomplete surgical excision (defined as residual tumour at either the peripheral or deep margin). Secondary outcomes will be risk factors that may affect incomplete excision (e.g. operating group, location of lesions, types of reconstruction, histological components). Data will not be extracted if the study uses other surgical techniques such as Mohs micrographic surgery, intra-operative frozen section, incision, shave or punch biopsies. Two investigators will independently screen all citations, full-text articles and abstract data. Potential conflicts will be resolved through discussion. No limitations will be imposed on publication status or language of publication. The study methodological quality (or bias) will be appraised using an appropriate tool. If feasible, we will conduct a random effect meta-analysis of observational data. Incidence estimates will be stratified according to cancer type (e.g. basal cell carcinoma vs squamous cell carcinoma) and operating group (e.g. dermatology, plastic surgery and general practice). Additional analyses will be conducted to explore the potential sources of heterogeneity (e.g. methodological quality, sample size).

DISCUSSION

This systematic review will summarise the best available evidence and definitively establish the incidence of incomplete surgical excision in non-melanoma skin cancer. It will determine if there is variation observed amongst different operating groups and provide some evidence for potential other factors causing this difference. This knowledge will provide a standard for future audits and will contribute to improving the treatment of non-melanoma skin cancer treatment.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO CRD42019157936.

摘要

背景

非黑色素瘤皮肤癌包括基底细胞癌和皮肤鳞状细胞癌,是全球最常见的恶性肿瘤。治疗的主要方法是手术切除。尽管这是一种非常常见的手术,但目前尚不清楚不完整切除的公认标准是什么。以前有多项单中心、区域性和全国性研究分别报告了他们孤立的不完整切除的发生率。此外,目前尚不清楚潜在的危险因素(如手术组、病变位置、重建类型、组织学成分或使用放大镜放大倍数)对不完整切除的发生率有何影响。本研究的目的将是系统地评估目前全球非黑色素瘤皮肤癌成年患者手术切除不完全的观察性数据。

方法

我们设计并注册了一项系统评价和描述性流行病学数据荟萃分析的研究方案。将进行全面的文献检索(从 2000 年 1 月开始),检索 MEDLINE、EMBASE、Scopus、CINAHL、EMCare 和 Cochrane 图书馆。通过搜索 Open Grey、论文数据库(例如开放获取论文和论文)和临床试验登记处(例如世卫组织传染病和临床研究培训计划)确定灰色文献。将纳入报告非黑色素瘤皮肤癌成年患者手术切除不完全发生率的观察性研究(队列、横断面、病例系列和临床审计)。主要结局是手术切除不完全的发生率(定义为周边或深部边缘残留肿瘤)。次要结局将是可能影响不完全切除的危险因素(例如手术组、病变位置、重建类型、组织学成分)。如果研究使用其他手术技术,如莫氏显微外科手术、术中冷冻切片、切开、刮除或打孔活检,则不会提取数据。两名研究人员将独立筛选所有引文、全文文章和摘要数据。潜在的冲突将通过讨论解决。不会对发表状态或语言施加限制。将使用适当的工具评估研究的方法学质量(或偏倚)。如果可行,我们将对观察性数据进行随机效应荟萃分析。发病率估计将根据癌症类型(例如基底细胞癌与鳞状细胞癌)和手术组(例如皮肤科、整形外科和普通科)进行分层。将进行额外的分析以探索潜在的异质性来源(例如方法学质量、样本量)。

讨论

本系统评价将总结最佳现有证据,并明确确定非黑色素瘤皮肤癌手术切除不完全的发生率。它将确定不同手术组之间是否存在差异,并为导致这种差异的其他潜在因素提供一些证据。这方面的知识将为未来的审计提供一个标准,并有助于改善非黑色素瘤皮肤癌的治疗。

系统评价注册

PROSPERO CRD42019157936。

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