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MEDLINE索引的已发表临床研究/试验中的时间箭头:对1960年至2017年回顾性与前瞻性研究设计的系统分析。

Time arrow in published clinical studies/trials indexed in MEDLINE: a systematic analysis of retrospective vs. prospective study design, from 1960 to 2017.

作者信息

Ciulla Michele M, Vivona Patrizia

机构信息

Laboratory of Clinical Informatics and Cardiovascular Imaging; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.

Cardiovascular Diseases Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.

出版信息

PeerJ. 2019 Feb 1;7:e6363. doi: 10.7717/peerj.6363. eCollection 2019.

Abstract

Clinical studies/trials are experiments or observations on human subjects considered by the scientific community the most appropriate instrument to answer specific research questions on interventions on health outcomes. The time-line of the observations might be focused on a single time point or to follow time, backward or forward, in the so called, respectively, retrospective and prospective study design. Since the retrospective approach has been criticized for the possible sources of errors due to bias and confounding, we aimed this study to assess if there is a prevalence of retrospective vs. prospective design in the clinical studies/trials by querying MEDLINE. Our results on a sample of 1,438,872 studies/trials, (yrs 1960-2017), support a prevalence of retrospective, respectively 55% vs. 45%. To explain this result, a random sub-sample of studies where the country of origin was reported ( = 1,576) was categorized in high and low-income based onthe nominal Gross Domestic Product (GDP) and matched with the topic of the research. As expected, the absolute majority of studies/trials are carried on by high-income countries, respectively 86% vs. 14%; even if a slight prevalence of retrospective was recorded in both income groups, for the most part prospective studies are carried out by high-GDP countries, 85% vs. 15%. Finally, the differences in the design of the study are understandable when considering the topic of the research.

摘要

临床研究/试验是针对人类受试者进行的实验或观察,科学界认为这是回答有关健康结果干预措施的特定研究问题的最合适工具。观察的时间线可能集中在单个时间点,或者在所谓的回顾性和前瞻性研究设计中分别向前或向后跟踪时间。由于回顾性方法因偏差和混杂因素可能导致误差来源而受到批评,我们旨在通过查询MEDLINE来评估临床研究/试验中回顾性设计与前瞻性设计的流行情况。我们对1438872项研究/试验(1960 - 2017年)样本的结果支持回顾性设计的流行率,分别为55%对45%。为了解释这一结果,根据名义国内生产总值(GDP)将报告了原产国的研究随机子样本(= 1576)分为高收入和低收入,并与研究主题相匹配。正如预期的那样,绝大多数研究/试验由高收入国家进行,分别为86%对14%;即使在两个收入组中都记录到回顾性设计略有流行,但在很大程度上,前瞻性研究是由高GDP国家进行的,为85%对15%。最后,考虑到研究主题时,研究设计的差异是可以理解的。

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