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系统评价作者联系情况:一项横断面研究和调查的方案。

Contacting of authors by systematic reviewers: protocol for a cross-sectional study and a survey.

机构信息

Department of Oral and Maxillofacial Surgery, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.

Private practice of orthodontics, Via Matteo Bandello 15, 20123, Milan, Italy.

出版信息

Syst Rev. 2017 Dec 8;6(1):249. doi: 10.1186/s13643-017-0643-z.

Abstract

BACKGROUND

Synthesizing outcomes of underreported primary studies can pose a serious threat to the validity of outcomes and conclusions of systematic reviews. To address this problem, the Cochrane Collaboration recommends reviewers to contact authors of eligible primary studies to obtain additional information on poorly reported items. In this protocol, we present a cross-sectional study and a survey to assess (1) how reviewers of new Cochrane intervention reviews report on procedures and outcomes of contacting of authors of primary studies to obtain additional data, (2) how authors reply, and (3) the consequences of these additional data on the outcomes and quality scores in the review. All research questions and methods were pilot tested on 2 months of Cochrane reviews and were subsequently fine-tuned.

METHODS FOR THE CROSS-SECTIONAL STUDY: Eligibility criteria are (1) all new (not-updates) Cochrane intervention reviews published in 2016, (2) reviews that included one or more primary studies, and (3) eligible interventions refer to contacting of authors of the eligible primary studies included in the review to obtain additional research data (e.g., information on unreported or missing data, individual patient data, research methods, and bias issues). Searching for eligible reviews and data extraction will be conducted by two authors independently. The cross-sectional study will primarily focus on how contacting of authors is conducted and reported, how contacted authors reply, and how reviewers report on obtained additional data and their consequences for the review.

METHODS FOR THE SURVEY

The same eligible reviews for the cross-sectional study will also be eligible for the survey. Surveys will be sent to the contact addresses of these reviews according to a pre-defined protocol. We will use Google Forms as our survey platform. Surveyees are asked to answer eight questions. The survey will primarily focus on the consequences of contacting authors of eligible primary studies for the risk of bias and Grading of Recommendations, Assessment, Development and Evaluation scores and the primary and secondary outcomes of the review.

DISCUSSION

The findings of this study could help improve methods of contacting authors and reporting of these procedures and their outcomes. Patients, clinicians, researchers, guideline developers, research sponsors, and the general public will all be beneficiaries.

摘要

背景

综合未报告的主要研究结果可能会严重威胁系统评价结果和结论的有效性。为了解决这个问题, Cochrane 协作组建议评论员联系有资格的主要研究的作者,以获取有关报告不充分项目的额外信息。在本方案中,我们进行了一项横断面研究和一项调查,以评估:(1)新 Cochrane 干预性评论的评论员如何报告联系主要研究作者以获取额外数据的程序和结果;(2)作者的回复情况;(3)这些额外数据对评论结果和质量评分的影响。所有研究问题和方法都在 2 个月的 Cochrane 评论中进行了试点测试,并随后进行了微调。

横断面研究方法

纳入标准为:(1)2016 年发表的所有新(非更新)Cochrane 干预性评论;(2)包括一项或多项主要研究的评论;(3)合格干预措施是指联系合格的主要研究作者以获取额外研究数据(例如,关于未报告或缺失数据、个体患者数据、研究方法和偏倚问题的信息)。由两名作者独立进行合格评论的搜索和数据提取。横断面研究将主要关注联系作者的方式以及报告方式、联系作者的回复方式,以及评论员报告获取的额外数据及其对评论的影响。

调查方法

横断面研究中的相同合格评论也将有资格参加调查。将根据预定义的方案,向这些评论的联系人地址发送调查。我们将使用 Google 表单作为我们的调查平台。调查对象被要求回答八个问题。调查将主要关注联系合格主要研究作者对偏倚风险和推荐、评估、制定和评估评分以及评论的主要和次要结果的影响。

讨论

本研究的结果可能有助于改进联系作者的方法以及这些程序和结果的报告。患者、临床医生、研究人员、指南制定者、研究赞助商和公众都将受益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e68/5721423/c1d0f97cc1ea/13643_2017_643_Fig1_HTML.jpg

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