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正畸干预不良反应报告、解读及外推中的偏差:一项系统评价横断面研究的方案

Spin in the reporting, interpretation, and extrapolation of adverse effects of orthodontic interventions: protocol for a cross-sectional study of systematic reviews.

作者信息

Steegmans Pauline A J, Di Girolamo Nicola, Meursinge Reynders Reint A

机构信息

Department of Orthodontics, Academisch Centrum Tandheelkunde Amsterdam (ACTA), University of Amsterdam, Gustav Mahlerlaan 3004, 1081 LA Amsterdam, The Netherlands.

2Center for Veterinary Health Sciences, Oklahoma State University, 2065 W Farm Road, Stillwater, OK 74078 USA.

出版信息

Res Integr Peer Rev. 2019 Dec 19;4:27. doi: 10.1186/s41073-019-0084-4. eCollection 2019.

Abstract

BACKGROUND

Titles and abstracts are the most read sections of biomedical papers. It is therefore important that abstracts transparently report both the beneficial and adverse effects of health care interventions and do not mislead the reader. Misleading reporting, interpretation, or extrapolation of study results is called "spin". In this study, we will assess whether adverse effects of orthodontic interventions were reported or considered in the abstracts of both Cochrane and non-Cochrane reviews and whether spin was identified and what type of spin.

METHODS

Eligibility criteria were defined for the type of study designs, participants, interventions, outcomes, and settings. We will include systematic reviews of clinical orthodontic interventions published in the five leading orthodontic journals and in the Cochrane Database. Empty reviews will be excluded. We will manually search eligible reviews published between 1 August 2009 and 31 July 2019. Data collection forms were developed a priori. All study selection and data extraction procedures will be conducted by two reviewers independently. Our main outcomes will be the prevalence of reported or considered adverse effects of orthodontic interventions in the abstract of systematic reviews and the prevalence of "spin" related to these adverse effects. We will also record the prevalence of three subtypes of spin, i.e., misleading reporting, misleading interpretation, and misleading extrapolation-related spin. All statistics will be calculated for the following groups: (1) all journals individually, (2) all journals together, and (3) the five leading orthodontic journals and the Cochrane Database of Systematic Reviews separately. Generalized linear models will be developed to compare the various groups.

DISCUSSION

We expect that our results will raise the awareness of the importance of reporting and considering of adverse effects and the presence of the phenomenon of spin related to these effects in abstracts of systematic reviews of orthodontic interventions. This is important, because an incomplete and inadequate reporting, interpretation, or extrapolation of findings on adverse effects in abstracts of systematic reviews can mislead readers and could lead to inadequate clinical practice. Our findings could result in policy implications for making judgments about the acceptance for publication of systematic reviews of orthodontic interventions.

摘要

背景

标题和摘要为生物医学论文中阅读量最高的部分。因此,摘要需透明地报告医疗保健干预措施的有益和不良影响,且不能误导读者,这一点很重要。对研究结果进行误导性的报告、解读或推断被称为“夸大”。在本研究中,我们将评估Cochrane综述和非Cochrane综述的摘要中是否报告或考虑了正畸干预措施的不良影响,是否识别出夸大情况以及夸大的类型。

方法

为研究设计类型、参与者、干预措施、结局和研究背景定义了纳入标准。我们将纳入发表在五本主要正畸期刊和Cochrane数据库中的临床正畸干预措施的系统评价。空的综述将被排除。我们将手动检索2009年8月1日至2019年7月31日期间发表的符合条件的综述。数据收集表预先制定。所有研究选择和数据提取程序将由两名评审员独立进行。我们的主要结局将是系统评价摘要中报告或考虑的正畸干预措施不良影响的发生率,以及与这些不良影响相关的“夸大”发生率。我们还将记录三种夸大亚型的发生率,即误导性报告、误导性解读和误导性推断相关的夸大。将针对以下几组计算所有统计数据:(1)各本期刊单独计算;(2)所有期刊一起计算;(3)五本主要正畸期刊和Cochrane系统评价数据库分别计算。将建立广义线性模型以比较不同组。

讨论

我们预计我们的结果将提高人们对在正畸干预措施系统评价摘要中报告和考虑不良影响以及与这些影响相关的夸大现象的重要性的认识。这很重要,因为在系统评价摘要中对不良影响的发现进行不完整和不充分的报告、解读或推断可能会误导读者,并可能导致临床实践不足。我们的研究结果可能会对判断正畸干预措施系统评价的发表接受度产生政策影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d8c6/6921451/4d0e827165c1/41073_2019_84_Fig1_HTML.jpg

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