A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010.
A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010.
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范围界定审查发现了多个建议修改 SPIRIT 2013 和 CONSORT 2010 的评论。
DOI：
10.1016/j.jclinepi.2023.01.003
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发表时间：
2023
影响因子：
7.2
通讯作者：
Nejstgaard CH
中科院分区：
文献类型：
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作者：
Nejstgaard CH
目的识别、总结和分析关于随机试验方案核心报告指南的评论（标准协议项目：干预性试验[SPIRIT] 2013）和已完成试验的建议（试验报告统一标准[CONSORT] 2010），特别强调了指南修改的建议。方法我们纳入了2010年后出版的英文文献，在SPIRIT 2013或CONSORT 2010上发表评论。我们检索了四个文献数据库（Embase和MEDLINE，截至2022年6月; Web of Science和Google Scholar，截至2022年4月）和其他来源（例如，EQUATOR网络网站、BMC博客网络和BMJ快速反应部分）。两位作者独立评估了文件的合格性，并提取了基本特征和主要评论措辞的数据。我们将评论分为“对现有指南项目措辞的修改建议”、“对新项目的建议”或“对挑战或优势的反思”。我们提供了一个总结和建议的例子，并分类评论到那些直接联系到实证调查，是以前的方法论讨论的延续，或反映了新的方法developments.ResultsWe评估的2,320个潜在的合格文件的全文，包括93个文件与114条评论。共有37条评论建议修改现有指南项目。CONSORT 2010的参与者流程部分收到的评论最多（8条评论提出了不同的建议，例如，一条评论建议增加非随机筛选参与者的人数）。有46条评论提出了新的项目。多项建议与试验干预相关（8条评论提出了不同的建议，例如，1条评论建议增加关于联合干预的内容）、设盲（6条评论建议增加关于揭盲风险的内容）、统计方法（5条评论提出了不同的建议，例如，一条评论建议增加关于统计学家设盲的内容）和参与者流动（7条评论提出了不同的建议，例如，三条评论建议增加关于缺失数据的内容）。一半（53%）的建议与实证调查直接相关。六（7%）的建议是以前的方法论讨论的延续，五（6%）的建议反映了新的方法学发展，涉及利益冲突和资金，数据共享，病人和公众参与。以及使用SPIRIT 2013和CONSORT 2010的试验的读者，并告知核心指南的计划更新。
ObjectivesTo identify, summarize, and analyse comments on the core reporting guidelines for protocols of randomized trials (Standard Protocol Items: Recommendations for Interventional Trials [SPIRIT] 2013) and for completed trials (Consolidated Standards of Reporting Trials [CONSORT] 2010), with special emphasis on suggestions for guideline modifications.MethodsWe included documents written in English and published after 2010 that explicitly commented on SPIRIT 2013 or CONSORT 2010. We searched four bibliographic databases (Embase and MEDLINE to June 2022; Web of Science and Google Scholar to April 2022) and other sources (e.g., the EQUATOR Network website, the BMC Blog Network, and the BMJ rapid response section). Two authors independently assessed documents for eligibility and extracted data on basic characteristics and the wording of the main comments. We categorized comments as ‘suggestion for modification to the wording of an existing guideline item,’ ‘suggestion for a new item,’ or ‘reflections on challenges or strengths.’ We provided a summary and examples of the proposed suggestions and categorized comments into those that were directly linked to empirical investigations, were continuations of previous methodological discussions, or reflected new methodological developments.ResultsWe assessed full text of 2,320 potentially eligible documents and included 93 documents with 114 comments. In total, 37 comments suggested modifications to existing guideline items. The participant flow section of CONSORT 2010 received the most comments (eight comments made different suggestions, e.g., one comment suggested to add numbers on nonrandomized screened participants). There were 46 comments suggesting new items. Multiple suggestions were related to trial interventions (eight comments made different suggestions, e.g., one comment suggested to add content on cointerventions), blinding (six comments suggested to add content on risk of unblinding), statistical methods (five comments made different suggestions, e.g., one comment suggested to add content on blinding of statisticians), and participant flow (seven comments made different suggestions, e.g., three comments suggested to add content on missing data). Half (53%) of the suggestions were directly linked to empirical investigations. Six (7%) suggestions were continuations of previous methodological discussions and five (6%) suggestions reflected new methodological developments related to conflicts of interest and funding, data sharing, and patient and public involvement.ConclusionThe issues raised provide context to authors, peer reviewers, editors, and readers of trials using SPIRIT 2013 and CONSORT 2010 and inform the planned updates of the core guidelines.