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Reporting of interventions used in cardiothoracic surgery trials: analysis using the Template for Intervention Description and Replication (TIDieR) checklist
The Cardiothoracic Surgeon Pub Date : 2020-02-18 , DOI: 10.1186/s43057-020-0018-4
Craig Beavers , Jessica Sosio , Samuel Jellison , Matt Vassar

To the editor,

Randomized controlled trials (RCTs) are the gold standard for evaluating intervention effectiveness [1] and advancing clinical practice in cardiothoracic surgery. Considering the importance of RCTs in cardiothoracic surgery, it is important that RCTs be reported in a thorough, clear, and complete manner. In this study, we evaluated the completeness of intervention reporting of cardiothoracic surgery RCTs using the Template for Intervention Reporting (TIDieR) checklist [2].

Our sample included trials published before the 2011–2013 and after 2016–2018 publication of the TIDieR checklist from the top 20 cardiothoracic surgery journals as ranked by Google Scholar h5-index. Title/abstract screening, evaluation of TIDieR adherence, and data extraction were performed by two investigators independently.

In 170 analyzed trials, the mean number of TIDieR items reported was 7.4 (SD = 1.2) out of 12. Five items were completely reported > 80% of the time and included (1) a brief description of the intervention, (2) the rationale for intervention, (3) a description of activities/processes used in the intervention, (4) a description of the mode of delivery and if it was provided individually or in a group, and (5) the number of times the intervention was delivered and over what period of time. Three items were reported in fewer than 20% of the trials including (1) whether modifications were made to the intervention, (2) fidelity assessment (planned), and (3) fidelity assessment (reality). Table 1 presents the results per TIDieR item for all analyzed trials. No included trials provided sufficient intervention description to fulfill all 12 TIDieR items.

Table 1 Characteristics of the included studies (N = 170)
Full size table

Our findings suggest incomplete reporting of RCTs published in cardiothoracic surgery journals. Complete reporting is important to allow for replication of the intervention in future trials, for physicians to implement the intervention into their clinical practice, and for systematic reviewers to have sufficient intervention information to include them for evidence synthesis [3]. The TIDieR checklist was developed to address incomplete reporting. Our results suggest, however, that the publication of TIDieR had no effect on completeness of intervention reporting among trials in our sample. More comprehensive dissemination strategies may be warranted to increase awareness of its existence. Alternatively, TIDieR could be incorporated into the well-established CONSORT guideline, the gold standard for reporting clinical trials. Given that CONSORT has a clear gap in intervention reporting guidance, the addition of TIDieR would contribute positively to the CONSORT items. Tiruvoipati et al. [4] reported that only 7.8% of cardiothoracic trials adequately reported a detailed description of trial setting and location and 26.6% of included trials provided details of the intervention. Findings from our study, coupled with previous investigations, support the need for improved reporting of cardiothoracic surgery trial interventions.

The methods, results, and data sets generated and/or analyzed during the current study are available on Open Science Framework, https://osf.io/hpx9g/

CONSORT:

Consolidated Standards of Reporting Trials

RCT:

Randomized controlled trial

SD:

Standard deviation

TIDieR:

Template for Intervention Description and Replication

  1. 1.

    Schulz KF, Altman DG, Moher D (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 340:c332

    Article Google Scholar

  2. 2.

    Hoffmann TC, Glasziou PP, Boutron I et al (2014) Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 348:g1687

    Article Google Scholar

  3. 3.

    Agha R, Cooper D, Muir G (2007) The reporting quality of randomised controlled trials in surgery: a systematic review. Int J Surg 5(6):413–422

    Article Google Scholar

  4. 4.

    Tiruvoipati R, Balasubramanian SP, Atturu G et al (2006) Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: the way forward. J Thorac Cardiovasc Surg 132(2):233–240

    Article Google Scholar

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Not applicable

This investigation was not funded.

Affiliations

  1. Oklahoma State University Center for Health Sciences, 1111 W 17th St., Tulsa, OK, 74107, USA
    • Craig Beavers
    • , Samuel Jellison
    •  & Matt Vassar
  2. Kansas City University of Medicine and Biosciences, 2901 St. John’s Boulevard, Joplin, MO, 74804, USA
    • Jessica Sosio
Authors
  1. Craig BeaversView author publicationsYou can also search for this author in
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    • Google Scholar
  2. Jessica SosioView author publicationsYou can also search for this author in
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  3. Samuel JellisonView author publicationsYou can also search for this author in
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  4. Matt VassarView author publicationsYou can also search for this author in
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    • Google Scholar

Contributions

CB and JS collected the data and performed the analysis. SJ conceived and designed the analysis. CB and SJ drafted the manuscript and performed critical revision of the manuscript. MV provided oversight of the study. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Craig Beavers.

Ethics approval and consent to participate

Not applicable

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

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Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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Beavers, C., Sosio, J., Jellison, S. et al. Reporting of interventions used in cardiothoracic surgery trials: analysis using the Template for Intervention Description and Replication (TIDieR) checklist. Cardiothorac Surg 28, 6 (2020). https://doi.org/10.1186/s43057-020-0018-4

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  • DOI: https://doi.org/10.1186/s43057-020-0018-4

中文翻译：
心胸外科手术中干预措施的报告：使用干预描述和复制模板（TIDieR）清单进行分析

对于编辑，

随机对照试验（RCT）是评估干预效果[1]和推进心胸外科临床实践的金标准。考虑到RCT在心胸外科中的重要性，重要的是要以彻底，清晰和完整的方式报告RCT。在这项研究中，我们使用干预报告模板（TIDieR）清单[2]评估了心胸外科RCT的干预报告的完整性。

我们的样本包括2011-2013年之前和2016-2018年之后发表的TIDieR清单中的试验，这些试验来自Google Scholar h5指数排名的前20种心胸外科杂志。标题/摘要筛选，TIDieR依从性评估以及数据提取由两名研究人员独立进行。

在170项经过分析的试验中，报告的TIDieR项目平均数为7.4（标准差= 1.2），占12个项目中的5个项目。> 80％的时间被完全报告，其中包括（1）干预措施的简要说明，（2）干预的理由；（3）干预中使用的活动/过程的描述；（4）交付方式的描述以及是单独提供还是以小组形式提供；以及（5）干预的次数交付以及在什么时间段内。不到20％的试验报告了三项，包括（1）是否对干预措施进行了修改，（2）保真度评估（计划中）和（3）保真度评估（真实性）。表1列出了所有分析试验的每个TIDieR项目结果。没有纳入的试验提供足够的干预描述来完成所有12个TIDieR项目。

表1纳入研究的特征（N  = 170）
全尺寸表

我们的发现表明，在心胸外科杂志上发表的RCT报告不完整。完整的报告对于在将来的试验中重复进行干预，使医生将干预措施应用于其临床实践以及使系统的审阅者具有足够的干预信息以包括证据以进行证据合成[3]至关重要。TIDieR清单旨在解决不完整的报告。然而，我们的结果表明，TIDieR的发表对我们样本中试验之间干预报告的完整性没有影响。可能需要采取更全面的传播策略来提高人们对其存在的认识。或者，可以将TIDieR纳入公认的CONSORT指南，这是报告临床试验的黄金标准。鉴于CONSORT在干预报告指南方面存在明显差距，因此添加TIDieR将对CONSORT各项做出积极贡献。Tiruvoipati等。[4]报告说，只有7.8％的心胸试验充分报告了试验设置和位置的详细说明，而26.6％的纳入试验提供了干预措施的详细信息。我们的研究结果与先前的研究相结合，支持对心胸外科手术试验干预措施进行改进报告的需求。

当前研究过程中生成和/或分析的方法，结果和数据集可在Open Science Framework（https://osf.io/hpx9g/）上获得。

配偶：

综合报告审理标准

RCT：

随机对照试验

SD：

标准偏差

标题：

干预说明和复制模板

  1. 1。

    Schulz KF，Altman DG，Moher D（2010）CONSORT 2010声明：更新的平行组随机试验报告指南。BMJ 340：c332

    文章Google学术搜索

  2. 2。

    Hoffmann TC，Glasziou PP，Boutron I等人（2014）更好地报告干预措施：干预措施描述和复制（TIDieR）清单和指南模板。BMJ 348：g1687

    文章Google学术搜索

  3. 3。

    Agha R，Cooper D，Muir G（2007）手术中随机对照试验的报告质量：系统评价。国际外科杂志5（6）：413–422

    文章Google学术搜索

  4. 4。

    Tiruvoipati R，Balasubramanian SP，Atturu G等人（2006）提高心胸外科手术随机对照试验报告质量：前进的道路。胸腔心血管外科杂志132（2）：233–240

    文章Google学术搜索

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隶属关系

  1. 俄克拉何马州立大学健康科学中心，美国宾夕法尼亚州塔尔萨市1111 W 17th St.，美国74107
    • 克雷格·海狸
    • ，塞缪尔·杰里森
    •  ＆马特·瓦萨（Matt Vassar）
  2. 美国密苏里州乔普林市，圣约翰大道2901号，堪萨斯城医科与生物科学大学，美国74804
    • 杰西卡·索西奥（Jessica Sosio）
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会费

CB和JS收集了数据并进行了分析。SJ构思并设计了分析。CB和SJ起草了手稿并对其进行了严格的修订。MV提供了对研究的监督。所有作者阅读并认可的终稿。

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引用本文

Beavers，C.，Sosio，J.，Jellison，S。等。心胸外科手术中使用的干预措施的报告：使用干预描述和复制模板（TIDieR）清单进行分析。Cardiothorac外科杂志 28， 6（2020）。https://doi.org/10.1186/s43057-020-0018-4

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  • DOI ：https ：//doi.org/10.1186/s43057-020-0018-4
更新日期：2020-02-18
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