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预防科研与出版领域不当行为并促进诚信的干预措施。

Interventions to prevent misconduct and promote integrity in research and publication.

作者信息

Marusic Ana, Wager Elizabeth, Utrobicic Ana, Rothstein Hannah R, Sambunjak Dario

机构信息

Department of Research in Biomedicine and Health, University of Split School of Medicine, Soltanska 2, Split, Croatia, 21000.

出版信息

Cochrane Database Syst Rev. 2016 Apr 4;4(4):MR000038. doi: 10.1002/14651858.MR000038.pub2.

Abstract

BACKGROUND

Improper practices and unprofessional conduct in clinical research have been shown to waste a significant portion of healthcare funds and harm public health.

OBJECTIVES

Our objective was to evaluate the effectiveness of educational or policy interventions in research integrity or responsible conduct of research on the behaviour and attitudes of researchers in health and other research areas.

SEARCH METHODS

We searched the CENTRAL, MEDLINE, LILACS and CINAHL health research bibliographical databases, as well as the Academic Search Complete, AGRICOLA, GeoRef, PsycINFO, ERIC, SCOPUS and Web of Science databases. We performed the last search on 15 April 2015 and the search was limited to articles published between 1990 and 2014, inclusive. We also searched conference proceedings and abstracts from research integrity conferences and specialized websites. We handsearched 14 journals that regularly publish research integrity research.

SELECTION CRITERIA

We included studies that measured the effects of one or more interventions, i.e. any direct or indirect procedure that may have an impact on research integrity and responsible conduct of research in its broadest sense, where participants were any stakeholders in research and publication processes, from students to policy makers. We included randomized and non-randomized controlled trials, such as controlled before-and-after studies, with comparisons of outcomes in the intervention versus non-intervention group or before versus after the intervention. Studies without a control group were not included in the review.

DATA COLLECTION AND ANALYSIS

We used the standard methodological procedures expected by Cochrane. To assess the risk of bias in non-randomized studies, we used a modified Cochrane tool, in which we used four out of six original domains (blinding, incomplete outcome data, selective outcome reporting, other sources of bias) and two additional domains (comparability of groups and confounding factors). We categorized our primary outcome into the following levels: 1) organizational change attributable to intervention, 2) behavioural change, 3) acquisition of knowledge/skills and 4) modification of attitudes/perceptions. The secondary outcome was participants' reaction to the intervention.

MAIN RESULTS

Thirty-one studies involving 9571 participants, described in 33 articles, met the inclusion criteria. All were published in English. Fifteen studies were randomized controlled trials, nine were controlled before-and-after studies, four were non-equivalent controlled studies with a historical control, one was a non-equivalent controlled study with a post-test only and two were non-equivalent controlled studies with pre- and post-test findings for the intervention group and post-test for the control group. Twenty-one studies assessed the effects of interventions related to plagiarism and 10 studies assessed interventions in research integrity/ethics. Participants included undergraduates, postgraduates and academics from a range of research disciplines and countries, and the studies assessed different types of outcomes.We judged most of the included randomized controlled trials to have a high risk of bias in at least one of the assessed domains, and in the case of non-randomized trials there were no attempts to alleviate the potential biases inherent in the non-randomized designs.We identified a range of interventions aimed at reducing research misconduct. Most interventions involved some kind of training, but methods and content varied greatly and included face-to-face and online lectures, interactive online modules, discussion groups, homework and practical exercises. Most studies did not use standardized or validated outcome measures and it was impossible to synthesize findings from studies with such diverse interventions, outcomes and participants. Overall, there is very low quality evidence that various methods of training in research integrity had some effects on participants' attitudes to ethical issues but minimal (or short-lived) effects on their knowledge. Training about plagiarism and paraphrasing had varying effects on participants' attitudes towards plagiarism and their confidence in avoiding it, but training that included practical exercises appeared to be more effective. Training on plagiarism had inconsistent effects on participants' knowledge about and ability to recognize plagiarism. Active training, particularly if it involved practical exercises or use of text-matching software, generally decreased the occurrence of plagiarism although results were not consistent. The design of a journal's author contribution form affected the truthfulness of information supplied about individuals' contributions and the proportion of listed contributors who met authorship criteria. We identified no studies testing interventions for outcomes at the organizational level. The numbers of events and the magnitude of intervention effects were generally small, so the evidence is likely to be imprecise. No adverse effects were reported.

AUTHORS' CONCLUSIONS: The evidence base relating to interventions to improve research integrity is incomplete and the studies that have been done are heterogeneous, inappropriate for meta-analyses and their applicability to other settings and population is uncertain. Many studies had a high risk of bias because of the choice of study design and interventions were often inadequately reported. Even when randomized designs were used, findings were difficult to generalize. Due to the very low quality of evidence, the effects of training in responsible conduct of research on reducing research misconduct are uncertain. Low quality evidence indicates that training about plagiarism, especially if it involves practical exercises and use of text-matching software, may reduce the occurrence of plagiarism.

摘要

背景

临床研究中的不当做法和不专业行为已被证明浪费了大量医疗保健资金,并损害了公众健康。

目的

我们的目的是评估教育或政策干预措施在研究诚信或研究的负责任行为方面对健康及其他研究领域研究人员的行为和态度的有效性。

检索方法

我们检索了Cochrane中心对照试验注册库(CENTRAL)、医学文献数据库(MEDLINE)、拉丁美洲及加勒比地区卫生科学数据库(LILACS)和护理学与健康领域数据库(CINAHL)等卫生研究书目数据库,以及学术搜索完整版数据库(Academic Search Complete)、农业与生命科学数据库(AGRICOLA)、地理参考数据库(GeoRef)、心理学文摘数据库(PsycINFO)、教育资源信息中心数据库(ERIC)、Scopus数据库和科学引文索引数据库(Web of Science)。我们于2015年4月15日进行了最后一次检索,检索限于1990年至2014年(含)发表的文章。我们还检索了会议论文集以及研究诚信会议的摘要和专业网站。我们手工检索了14种定期发表研究诚信研究的期刊。

选择标准

我们纳入了测量一种或多种干预措施效果的研究,即任何可能对研究诚信和最广义的研究负责任行为产生影响的直接或间接程序,其中参与者是研究和出版过程中的任何利益相关者,从学生到政策制定者。我们纳入了随机对照试验和非随机对照试验,如前后对照研究,比较干预组与非干预组的结果或干预前后的结果。没有对照组的研究未纳入本综述。

数据收集与分析

我们采用了Cochrane预期的标准方法程序。为评估非随机研究中的偏倚风险,我们使用了一种改良的Cochrane工具,其中我们使用了六个原始领域中的四个(盲法、不完整的结局数据、选择性结局报告、其他偏倚来源)以及另外两个领域(组间可比性和混杂因素)。我们将主要结局分为以下几个层次:1)归因于干预的组织变革,2)行为改变,3)知识/技能的获得,4)态度/观念的改变。次要结局是参与者对干预的反应。

主要结果

33篇文章中描述的31项研究涉及9571名参与者,符合纳入标准。所有研究均以英文发表。15项研究为随机对照试验,9项为前后对照研究,4项为有历史对照的非等效对照研究,1项为仅进行后测的非等效对照研究,2项为干预组有前后测结果且对照组仅有后测结果的非等效对照研究。21项研究评估了与剽窃相关的干预措施的效果;10项研究评估了研究诚信/伦理方面的干预措施。参与者包括来自一系列研究学科和国家的本科生、研究生和学者,这些研究评估了不同类型的结局。我们判断大多数纳入的随机对照试验在至少一个评估领域存在高偏倚风险,对于非随机试验,未尝试减轻非随机设计中固有的潜在偏倚。我们确定了一系列旨在减少研究不当行为的干预措施。大多数干预措施涉及某种培训,但方法和内容差异很大,包括面对面和在线讲座、交互式在线模块、讨论组、作业和实践练习。大多数研究未使用标准化或经过验证的结局测量方法,因此无法综合来自具有如此多样的干预措施、结局和参与者的研究结果。总体而言,证据质量极低,表明各种研究诚信培训方法对参与者对伦理问题的态度有一定影响,但对其知识的影响极小(或短暂)。关于剽窃和释义的培训对参与者对剽窃的态度及其避免剽窃的信心有不同影响,但包括实践练习的培训似乎更有效。关于剽窃的培训对参与者关于剽窃的知识及其识别剽窃的能力有不一致的影响。积极培训,特别是如果涉及实践练习或使用文本匹配软件,通常会减少剽窃的发生,尽管结果并不一致。期刊作者贡献表的设计影响了关于个人贡献所提供信息的真实性以及符合作者标准的列出贡献者的比例。我们未发现测试组织层面结局干预措施的研究。事件数量和干预效果的大小通常较小,因此证据可能不准确。未报告不良反应。

作者结论

与改善研究诚信干预措施相关的证据基础不完整,已开展的研究具有异质性,不适用于荟萃分析,其对其他环境和人群的适用性也不确定。由于研究设计的选择,许多研究存在高偏倚风险,干预措施的报告往往不充分。即使使用了随机设计,研究结果也难以推广。由于证据质量极低,关于研究的负责任行为培训对减少研究不当行为的效果尚不确定。低质量证据表明,关于剽窃特别是涉及实践练习和使用文本匹配软件的培训可能会减少剽窃的发生。

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