CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials.

CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials.
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DOI:
10.1186/s13063-018-2735-z
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发表时间:
2018-07-31
期刊:
影响因子:
2.5
通讯作者:
, on behalf of the CONSORT-SPI Group
, on behalf of the CONSORT-SPI Group
中科院分区:
医学4区
文献类型:
--
作者:
Grant S;Mayo-Wilson E;Montgomery P;Macdonald G;Michie S;Hopewell S;Moher D;, on behalf of the CONSORT-SPI Group

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CONSORT(报告试验的统一标准)声明的制定是为了帮助生物医学研究人员透明地报告随机对照试验(RCT)。我们开发了CONSORT 2010社会和心理干预声明(CONSORT-SPI 2018)的扩展,以帮助行为和社会科学家透明地报告这些研究。在对现有报告指南进行系统性审查后,我们进行了在线德尔菲过程,以优先考虑从系统性审查中确定的CONSORT-SPI 2018检查表的潜在项目列表。在384名国际参与者中,321人(84%)参加了两轮评级。然后,我们举行了一次由31名科学家、期刊编辑和研究资助者参加的共识会议(2014年3月),以最终确定CONSORT-SPI 2018检查表和流程图的内容。CONSORT-SPI 2018扩展了CONSORT 2010检查表中的9个项目(14个包括子项目),增加了与利益相关者参与试验相关的新项目(3个子项目),并修改了CONSORT 2010流程图。本解释和评估(E&E)文档是一份用户手册,旨在加深对CONSORT-SPI 2018的理解。它讨论了清单中每一项目的含义和理由,并提供了完整和透明的报告实例。CONSORT-SPI 2018扩展,本E&E文件和CONSORT网站(www.consort-statement.org)是改善社会和心理干预RCT报告的有用资源。本文的在线版本(10.1186/s13063-018-2735-z)包含补充材料,可供授权用户使用。
The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently. Following a systematic review of existing reporting guidelines, we conducted an online Delphi process to prioritise the list of potential items for the CONSORT-SPI 2018 checklist identified from the systematic review. Of 384 international participants, 321 (84%) participated in both rating rounds. We then held a consensus meeting of 31 scientists, journal editors, and research funders (March 2014) to finalise the content of the CONSORT-SPI 2018 checklist and flow diagram. CONSORT-SPI 2018 extends 9 items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with 3 sub-items) related to stakeholder involvement in trials, and modifies the CONSORT 2010 flow diagram. This Explanation and Elaboration (E&E) document is a user manual to enhance understanding of CONSORT-SPI 2018. It discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting. The CONSORT-SPI 2018 Extension, this E&E document, and the CONSORT website (www.consort-statement.org) are helpful resources for improving the reporting of social and psychological intervention RCTs. The online version of this article (10.1186/s13063-018-2735-z) contains supplementary material, which is available to authorized users.
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