在报告观察性研究时遵守STROBE检查表的重要性:不仅仅是打勾练习

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在报告观察性研究时遵守STROBE检查表的重要性:不仅仅是打勾练习

2024-07-12 09:58| 来源: 网络整理| 查看: 265

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With increasing interest in the quality of published research within the scientific community, inadequate reporting has been identified as a widespread issue in biomedical research for several years (Glasziou et al., 2014). Poor reporting of research is unethical, it wastes time and valuable resources and can be potentially detrimental to patient care (Moher, 2018). Poor, or insufficient, reporting may hinder the possibility of nurses being able to effectively translate the findings of a nursing observational study into practice-based improvements. If an author forgets or neglects to report important information about their study, it can lead to a delay in the publication of the paper, reduce the chances of the study being cited and potentially prevent it from being included in evidence-synthesis studies. If a study has not been reported clearly, completely and transparently, replication can be near impossible. Insufficient attention to reporting may also make it difficult for the reader to fully assess the strengths and weaknesses of a study. To deal with all these issues, the EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research; 2020), an international initiative that aims to systematically address issues of poor reporting in biomedical research, was established in 2006. EQUATOR provides robust guidelines that confirm that academic papers are rigorously and transparently reported.

Within nursing research, high-quality observational studies can provide the answers to important research questions, these studies can be descriptive, comparative and analytical. As part of the EQUATOR Network, the Strengthening of Reporting of Observational Studies in Epidemiology (STROBE) guidelines were originally formulated in 2007 (von Elm et al., 2007). Constantly evolving since its inception, STROBE was developed to improve the transparency and accuracy in the reporting of observational studies, across cohort, case−control and cross-sectional studies. The 22-item STROBE checklist which relates to the conventional sections of an academic research paper can be found on the STROBE website.org. An explanatory and elaborative paper outlining the meaning and rationale of the STROBE accompanies the checklist (Vandenbroucke et al., 2014). STROBE has increasingly become a requisite for authors wishing to publish observational studies in biomedical journals.

STROBE adherence can greatly enhance the quality and transparency in observational research, an important ethical obligation in publication.

In this editorial, we examine the use and misuse of STROBE in nursing research. Specific attention is given to the need for greater guideline awareness to ensure better adherence, with focus on the importance of reporting of confounding in observational research.

At the Journal of Advanced Nursing, we require authors of observational research to adhere to the STROBE guidelines. When applied appropriately, we believe that STROBE can have a positive impact on the quality of reporting an observational study. Therefore, we encourage researchers to become familiar with STROBE as early as possible, from the study design phase through to the reporting stages of an observational study. However, even when academic journals mandate responsible reporting practices, it does not imply that authors will necessarily appreciate their importance. Worryingly, in one study of quality of reporting in observational research, Pouwels et al. (2016) reported that many authors were often unaware of the use of STROBE or its existence.

Despite its strengths, the STROBE checklist does come with limitations, it is only limited to three main types of observational study design; however, several extensions now exist. The checklist was originally conceived as ‘a life jacket not a strait jacket’, as such, it was not intended to be a strict and rigid method of reporting findings, it merely provides guidance on the most important items that need to be considered in a manuscript. However, some authors believe that the constraints of STROBE are too rigid, adhering to the level of methodological rigour required can be very challenging (Larsson, 2022).

If inadequate attention is given to publication reporting in observational research, there is always the potential risk of bias, including confounding. In observational studies, addressing bias that is related to confounding is of great importance. Confounders, which are extraneous variables that can distort the distinction between exposure and outcome can be common in observational research, mainly due to lack of randomization which is not applicable in this type of research.

Confounders can lead to the masking of a true effect or association or can make it appear that there is an association between the exposure and outcome when no true association exists. Within the psychiatric specialty journals, Munkholm et al. (2020) identified poor quality of reporting of confounding to be widespread and potentially problematic as bias related to confounding may present as a major limitation in observational research. Specifically, they noted the term ‘confounding’ was only mentioned in the abstract or discussion of around half (55%) of identified papers and only around a fifth of authors gave any acknowledgement of confounding in their findings. With multiple items within the STROBE checklist devoted to confounding, attention has been given to assess whether reporting of confounding can be enhanced with STROBE adherence. Using STROBE, authors are encouraged to provide a clear rationale for their choice of statistical covariates, all confounders should be identified and defined. In relation to precision, STROBE requests that due attention is given to providing unadjusted and adjusted confounder-adjusted estimates. It has been suggested that even when STROBE is applied appropriately, the standard of reporting studies can remain sub-optimal (Sharp et al., 2019). Despite noting improvements in the reporting of confounding, Pouwels et al. (2016) found little difference in reporting quality between those journals that endorsed STROBE, and those that did not, this may be potentially related to STROBE misuse. For several years, concerns have been raised about the misuse of STROBE, it has commonly been used as a tool to assess methodological quality of a study or as a template for study design, despite clear indication for the developers that it is a guide to reporting research (da Costa et al., 2011). As confounding can be a major limitation of observational research, closer attention, with careful interpretation of study findings, needs to be given to this issue in nursing research, addressing confounding and other aspects of bias.

More than just endorsing STROBE reporting guidelines, we feel that is timely and important for our authors to have a greater awareness of STROBE and ways to adhere to it. It is important for prospective authors to realize that STROBE adherence is much more than just a ‘tick box’ exercise, but that appropriate time and consideration are needed to ensure that they have correctly interpreted and applied the tool. In our experience, this may not always be clearly apparent. At the Journal of Advanced Nursing, authors of observational studies are strongly encouraged to dedicate sufficient time to familiarize themselves with STROBE guidelines and to complete the checklist thoroughly and correctly, this requires more than just stating page numbers. So how can our potential authors enhance STROBE adherence? Although vital, endorsing reporting guidelines within journal author guidelines may not be enough. Some journals, like PLOS Medicine, have gone one step further and require authors not only to submit a completed checklist, but they also require authors to submit text from their manuscript to provide justification for their responses to the checklist questions (PLOS Medicine Editors, 2014).

Merely attaching a STROBE checklist with a manuscript does not demonstrate adherence within a study, and at the Journal of Advanced Nursing, we also request that reference should be made to the checklist in the abstract and in the main body of the text within the methods section. Appropriate completion of the checklist allows reviewers and readers a greater appreciation on key aspects of an observational study, like issues of bias, confounding and generalizability. In addition to the checklist, we also encourage our authors to take the time to consult the explanatory and elaborative paper, outlining the meaning, rationale and use of the STROBE checklist (Vandenbroucke et al., 2014). Authors should also provide key information about their study design and population providing clear definition of outcomes predictors and potential confounders. Any attempts to eliminate or reduce bias should be clearly outlined by the author in the methods section of the paper.

The integrity and validity of journal publications in any academic discipline are dependent on a high-quality peer review process (Smith & Jackson, 2022). Awareness of reporting guidelines may also help peer reviewers in their assessment of a manuscript. At the Journal of Advanced Nursing, reviewers are strongly encouraged to refer to STROBE reporting guidelines to ensure methodological rigour in observational studies.

It has been suggested that training and education on the use of reporting checklists, including STROBE, should be incorporated within postgraduate nursing education (McEvoy et al., 2022). We advocate the core teaching of all reporting guidelines, including STROBE, at an early stage of postgraduate research training to ensure awareness of the existence and importance of these checklists and guidelines. In the communication and dissemination phases of the research process, students could be taught about the ways to achieve STROBE adherence, leading to the enhancement of the quality of their manuscript, rather than just being seen as an onerous administrative task. Although time consuming to complete, when used appropriately, STROBE guidelines can improve the overall quality of an observational paper, potentially enhancing the chances of publication acceptance.

At the Journal of Advanced Nursing, we aim to publish the highest quality nurse research papers for our readership and require that reporting guidelines are precisely followed to ensure that our publications, including observational studies, have transparency and can be judged appropriately by our readers. Although using this guideline does not reflect the methodological quality of a study, greater effort needs to be given to ways to encourage nursing authors to fully adhere to STROBE reporting guidelines when reporting observational research.

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随着科学界对已发表研究的质量的兴趣日益增加,不充分的报告已被确定为生物医学研究中多年来的普遍问题(Glasziou等人,& nbsp; 2014年)。研究报告不佳是不道德的,它浪费了时间和宝贵的资源,可能对患者护理造成潜在损害(Moher, 2018)。差,或不足,报告可能会阻碍护士能够有效地将护理观察性研究的结果转化为实践为基础的改进的可能性。如果作者忘记或忽略报告有关其研究的重要信息,可能会导致论文发表延迟,降低研究被引用的机会,并可能阻止其被纳入证据合成研究。如果一项研究没有得到明确、完整和透明的报告,复制几乎是不可能的。对报告关注不足也可能使读者难以充分评估研究的优点和缺点。为了解决所有这些问题,2006年成立了EQUATOR网络(增强健康研究的质量和透明度; 2020年),这是一项旨在系统地解决生物医学研究报告不足问题的国际倡议。EQUATOR提供了强有力的指导方针,确认学术论文的报告是严格和透明的。

在护理研究中,高质量的观察性研究可以为重要的研究问题提供答案,这些研究可以是描述性的,比较性的和分析性的。作为EQUATOR网络的一部分,加强流行病学观察性研究的报告(STROBE)指南最初是在2007年制定的(von Elm等人,& nbsp; 2007年)。STROBE自成立以来不断发展,旨在提高观察性研究报告的透明度和准确性,包括跨队列、病例对照和横断面研究。与学术研究论文的常规部分相关的22项STROBE检查表可以在STROBE网站上找到。概述了选通的含义和基本原理的解释性和详尽的论文伴随着检查表(Vandenbroucke等人,& nbsp; 2014年)。对于希望在生物医学期刊上发表观察性研究的作者来说,STROBE已经越来越成为一种必需品。

遵守STROBE可以大大提高观察性研究的质量和透明度,这是出版物中的一项重要道德义务。

在这篇社论中,我们研究的使用和误用频闪在护理研究。特别注意的是需要更大的指南意识,以确保更好的遵守,重点是观察性研究中的混杂报告的重要性。

在《高级护理杂志》上,我们要求观察性研究的作者遵守STROBE指南。如果应用得当,我们认为STROBE可以对观察性研究的报告质量产生积极影响。因此,我们鼓励研究人员尽早熟悉STROBE,从研究设计阶段到观察性研究的报告阶段。然而,即使学术期刊要求负责任的报道实践,这并不意味着作者一定会意识到它们的重要性。令人担忧的是,在一项关于观察性研究报告质量的研究中,Pouwels等人& nbsp;(2016)报告称,许多作者通常不知道STROBE的使用或其存在。

尽管STROBE检查表有其优点,但也有局限性,它仅限于三种主要类型的观察性研究设计;然而,现在存在几个扩展。检查表最初被设想为“救生衣而不是紧身衣”,因此,它并不打算成为报告结果的严格和僵化的方法,它只是为手稿中需要考虑的最重要的项目提供指导。然而,一些作者认为STROBE的约束过于严格,坚持所需的方法学严格性水平可能非常具有挑战性(Larsson, 2022)。

如果对观察性研究中的出版物报告关注不足,则始终存在偏倚的潜在风险,包括混杂。在观察性研究中,解决与混杂相关的偏倚非常重要。混杂因素是可能扭曲暴露和结局之间区别的外来变量,在观察性研究中可能很常见,主要是由于缺乏随机化,这在此类研究中不适用。

混杂因素可能导致掩盖真实效应或关联,或者可能使暴露与结果之间似乎存在关联,而实际上不存在关联。在精神病学专业期刊中,Munkholm等人和nbsp;(2020)发现混杂因素报告质量差是普遍存在的,可能存在问题,因为与混杂因素相关的偏倚可能是观察性研究的主要限制。具体来说,他们指出,“混杂”一词仅在大约一半(55%)的已识别论文的摘要或讨论中提到,只有大约五分之一的作者在他们的发现中承认了混杂。由于STROBE检查表中有多个项目专门用于混杂,因此已注意评估是否可以通过遵守STROBE来增强混杂的报告。使用STROBE,鼓励作者提供其选择统计协变量的明确理由,应识别和定义所有混杂因素。关于精确度,STROBE要求适当注意提供未调整和调整后的混杂因素调整估计值。已经提出,即使当适当地应用STROBE时,报告研究的标准也可以保持次优(Sharp等人,& nbsp; 2019年)。尽管注意到混杂因素的报告有所改善,Pouwels等人和nbsp;(2016)发现,认可STROBE的期刊与未认可STROBE的期刊之间的报告质量几乎没有差异,这可能与STROBE滥用有关。几年来,人们对STROBE的滥用提出了担忧,它通常被用作评估研究的方法学质量的工具或研究设计的模板,尽管开发者明确指出它是报告研究的指南(da Costa等人,& nbsp; 2011年)。由于混杂可能是观察性研究的一个主要局限性,因此在护理研究中需要对这一问题给予更密切的关注,并对研究结果进行仔细的解释,以解决混杂和其他方面的偏见。

不仅仅是赞同STROBE报告指南,我们认为这是及时和重要的,我们的作者有一个更大的意识STROBE和方法来坚持它。重要的是,准作者要认识到,STROBE的坚持不仅仅是一个“勾选框”的练习,但需要适当的时间和考虑,以确保他们正确地解释和应用该工具。根据我们的经验,这可能并不总是显而易见的。在《高级护理杂志》上,强烈鼓励观察性研究的作者投入足够的时间来熟悉STROBE指南,并彻底正确地完成检查表,这需要的不仅仅是说明页码。那么,我们的潜在作者如何提高STROBE的依从性呢?虽然重要,但在期刊作者指南中认可报告指南可能是不够的。一些期刊,如PLOS Medicine,更进一步,不仅要求作者提交完整的清单,而且还要求作者提交手稿中的文本,以证明他们对清单问题的回答是合理的(PLOS Medicine Editors,2014)。

仅随手稿附上STROBE检查表并不能证明研究中的依从性,在《高级护理杂志》上,我们还要求在方法部分的摘要和正文中参考检查表。适当填写检查表可以让评审者和读者更好地了解观察性研究的关键方面,如偏倚、混淆和可概括性问题。除了检查表之外,我们还鼓励我们的作者花时间查阅解释性和详细说明性论文,概述STROBE检查表的含义、原理和使用(Vandenbroucke等人,& nbsp; 2014年)。作者还应提供关于其研究设计和人群的关键信息,提供结局预测因素和潜在混杂因素的明确定义。作者应在论文的方法部分清楚地概述任何消除或减少偏倚的尝试。

任何学科期刊出版物的完整性和有效性都依赖于高质量的同行评审过程(Smith&杰克逊, 2022)。了解报告准则也有助于同行评审者对稿件的评估。在《高级护理杂志》上,强烈鼓励评论者参考STROBE报告指南,以确保观察性研究的方法学严谨性。

有人建议,应在研究生护理教育中纳入使用报告检查表(包括STROBE)的培训和教育(McEvoy等人,& nbsp; 2022年)。我们提倡在研究生研究培训的早期阶段,对所有报告指南(包括STROBE)进行核心教学,以确保对这些清单和指南的存在和重要性的认识。在研究过程的沟通和传播阶段,学生可以学习如何实现STROBE坚持,从而提高他们的手稿质量,而不仅仅是被视为一项繁重的行政任务。虽然完成起来很耗时,但如果使用得当,STROBE指南可以提高观察性论文的整体质量,潜在地增加发表接受的机会。

在《高级护理杂志》,我们的目标是为我们的读者发表最高质量的护士研究论文,并要求严格遵循报告指南,以确保我们的出版物(包括观察性研究)具有透明度,并可由我们的读者进行适当的判断。虽然使用本指南并不能反映研究的方法学质量,但需要付出更大的努力,以鼓励护理作者在报告观察性研究时完全遵守STROBE报告指南。

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