系统评价正畸干预措施的不良反应：一项横断面研究的方案。

Seeking adverse effects in systematic reviews of orthodontic interventions: protocol for a cross-sectional study.

机构信息

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

Department of Radiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.

出版信息

Syst Rev. 2019 Apr 5;8(1):89. doi: 10.1186/s13643-019-1000-1.

DOI:10.1186/s13643-019-1000-1

PMID:30953538

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6449933/

Abstract

BACKGROUND

Before implementing healthcare interventions, clinicians need to weigh the beneficial and adverse effects of interventions. However, a large body of evidence has demonstrated that seeking and reporting of adverse effects is suboptimal in clinical trials and in systematic reviews of interventions. This cross-sectional study will investigate the status of this problem in orthodontics. This study will assess whether adverse effects were sought and whether findings related to adverse effects were reported in systematic reviews of orthodontic interventions in the five leading orthodontic journals and in the Cochrane Database of Systematic Reviews.

METHODS

Systematic reviews of clinical orthodontic interventions published between 01 August 2009 and 31 July 2019 in the five leading orthodontic journals and in the Cochrane Database will be included. Empty reviews will be excluded. The reporting of outcomes on adverse effects will not determine eligibility, i.e., reviews will not be excluded, because they did not report usable data. Study selection and data extraction will be conducted independently by two authors. Our primary outcome will be the prevalence of systematic reviews of orthodontic interventions that sought any findings related to adverse effects in the included studies. Additional prevalence statistics will be calculated on a series of items related to seeking of adverse effects in the eligible reviews. All statistics will be calculated for (1) all journals together, (2) the group of five orthodontic journals and the Cochrane Database of Systematic Reviews separately, and (3) each individual journal separately. Chi-square tests of independence will be used to compare these groups.

DISCUSSION

This study will assess whether adverse effects were sought in systematic reviews of orthodontic interventions. This knowledge is important, because reviews that present an incomplete picture on adverse effects can have unfavorable consequences for the end-users. Also not reporting that no adverse effects were assessed in eligible studies included in a systematic review can mislead pertinent stakeholders. Our findings could have policy implications for making judgments on accepting or rejecting an intervention systematic review for publication, for example, by directing editors and peer-reviewers to adopt the various items on adverse effects defined in the MECIR standards and in the PRISMA harm checklist.

摘要

背景

在实施医疗干预措施之前，临床医生需要权衡干预措施的有益和不利影响。然而，大量证据表明，临床试验和干预措施的系统评价中对不良事件的报告和评估并不完善。本横断面研究将调查正畸领域中这一问题的现状。本研究将评估在五个主要正畸期刊和 Cochrane 系统评价数据库中发表的正畸干预措施的系统评价中是否评估了不良事件，以及是否报告了与不良事件相关的发现。

方法

将纳入 2009 年 8 月 1 日至 2019 年 7 月 31 日期间在五个主要正畸期刊和 Cochrane 系统评价数据库中发表的临床正畸干预措施的系统评价。将排除空的综述。不良事件结局的报告将不会决定入选，即不会因为未报告可用数据而排除综述。研究选择和数据提取将由两名作者独立进行。我们的主要结局是评估正畸干预措施系统评价中是否评估了纳入研究中与不良事件相关的任何发现。将对合格综述中与评估不良事件相关的一系列项目进行额外的流行率统计。所有统计数据将针对以下内容进行计算：（1）所有期刊汇总，（2）五个正畸期刊和 Cochrane 系统评价数据库组，（3）每个期刊单独计算。将使用独立性卡方检验比较这些组。

讨论

本研究将评估正畸干预措施的系统评价中是否评估了不良事件。了解这一点很重要，因为呈现不完整的不良事件图像的综述可能会对最终用户产生不利影响。另外，在系统评价中未报告纳入研究中未评估不良事件也会误导相关利益相关者。我们的研究结果可能对判断是否接受或拒绝发表干预措施的系统评价产生政策影响，例如，指导编辑和同行评审者采用 MECIR 标准和 PRISMA 伤害清单中定义的不良事件各项标准。