当代外科试验的特点、结果和报告:系统回顾和分析

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY
N. Bryce Robinson , Ajita Naik , Irbaz Hameed , Yongle Ruan , Mohamed Rahouma , Viola Weidenmann , Marco A. Zenati , Deepak L. Bhatt , Leonard N. Girardi , Paul Kurlansky , Shahzad G. Raja , David Moher , Stephen Fremes , Joanna Chikwe , Mario Gaudino
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引用次数: 1

摘要

外科和外科干预领域固有的复杂性和风险给外科随机对照试验(RCT)的设计和分析带来了独特的挑战。先前的研究已经调查了外科随机对照试验带来的实践和方法上的挑战。然而,到目前为止,对跨多个外科亚专科的当代文献的综合分析还不存在。在这一描述性分析中,我们开始对过去10年六个主要外科专业的外科随机对照试验进行特征分析。方法和分析由医学图书管理员进行文献检索,以确定2009年1月至2019年12月期间在六个外科专科影响因子最高的两种期刊和两个大型普通医学期刊上发表的所有外科随机临床试验。两名审稿人将独立筛选从文献检索中检索到的引文,并根据先前描述的方案通过预定义的数据收集表提取数据。分类变量将以计数和百分比报告。在评估正态性后,连续变量将以平均值(标准差)或中位数(四分位数间距)报告。根据数据的正态性,将使用独立t检验或Mann-Whitney U检验来比较连续变量,使用卡方检验和Fisher精确检验来比较分类变量。多组间的比较将使用方差分析或Kruskak-Wallis检验进行。将使用双侧显著性检验,p值<0.05将被认为显著,无需调整多重检验。所有的分析将使用SPSS版本24和RStudio内的R进行。普洛斯彼罗(身份证号:162797)。伦理与传播本系统综述不涉及直接相关的伦理问题。检索到的数据将根据要求提供。该研究将用英文撰写,并提交给同行评议的期刊发表。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Characteristics, results, and reporting of contemporary surgical trials: A systematic review and analysis

Introduction

The complexities and risks inherent to the field of surgery and surgical interventions present unique challenges to the design and analysis of surgical randomized controlled trials (RCT). Prior studies have investigated the practical and methodologic challenges posed by surgical RCTs. To date, however, a comprehensive analysis of the contemporary literature across multiple surgical subspecialties does not exist. In this descriptive analysis, we set out to characterize surgical RCTs over the past 10 years across six major surgical specialties.

Methods and analysis

A literature search by a medical librarian will be performed to identify all surgical randomized clinical trials published between January 2009 and December 2019 in the two journals with the highest impact factor for six surgical specialties as well as two large general medicine journals. Two reviewers will independently screen the citations retrieved from the literature search and extract data according to a previously described protocol via a pre-defined data collection form. Categorical variables will be reported as counts and percentages. Following assessment of normality, continuous variables will be reported as mean (standard deviation) or median (inter-quartile range). Based on normality of data, independent t-test or the Mann-Whitney U test will be used to compare continuous variables and chi-square and Fisher’s exact tests to compare categorical variables. Comparisons across multiple sets will be performed using ANOVA or Kruskak-Wallis tests. Two-sided significance testing will be used and a p-value <0.05 will be considered significant without adjustment for multiple testing. All analyses will be performed using SPSS version 24 and R within RStudio. PROSPERO (ID number: 162797).

Ethics and dissemination

There are no ethical concerns directly pertinent to this systematic review. The retrieved data will be made available upon request. The study will be written in English and submitted for publication in a peer-reviewed journal.

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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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