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[期刊发展] 资源导航:研究报告

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JEBM 发表于 2024-5-21 15:21:10 | 显示全部楼层 |阅读模式

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鼓励作者使用EQUATOR Network提供的针对不同研究类型的研究报告规范指南,确保您为编辑、审稿人和读者提供足够的信息,使他们能够理解研究是如何展开的,并评价研究结论的可靠性。

以下是一些关键的规范指南:
• 随机对照试验(RCTs):CONSORT指南
• 系统性综述和荟萃分析:PRISMA指南MOOSE指南
• 流行病学的观察性研究:STROBE指南MOOSE指南
• 诊断准确性研究:STARD指南
• 质量改进研究:SQUIRE指南
• 多变量预测模型:TRIPOD指南



研究报告指南(Research reporting guidelines)

研究文章(Research Papers)

撰写报告时请遵循以下指南。请务必按照指南规定安排文章结构。投稿时应上传完整填写的核对表、结构化摘要和研究流程图,这些也都将出现在最终刊出的文章中。

CONSORT Statement:适用于随机对照试验;需要进行提交的是Checklist中文版)和FlowDiagram中文版)。
- Checklist(清单)- 用以报告试验设计、分析及解读的过程;
- Flow Diagram(流程图)- 用以展示试验全程参与者的情况。
COREQ:适用于定性研究。
STARD:适用于诊断准确度研究;需要进行提交的是检查清单流程图
STROBE:适用于流行病学观察性研究;根据不同的研究类型选择检查清单(Checklist)。
- 队列、病例对照和横断面综合研究的检查清单
- 队列研究检查清单中文清单
- 病例对照研究检查清单
- 横断面研究检查清单
PRISMA:适用于系统综述;需要进行提交的是ChecklistFlow Diagram
MOOSE:适用于观察性研究的荟萃分析;
STREGA:适用于基因疾病相关研究;STREGA讨论会报告及指导草案
CHEERS:适用于卫生经济评估。

其他各种指南的下载见Equator Network

研究方案(Protocols)

研究方案是指计划中的或正在进行的研究。如果数据收集已经完成,投稿将不予考虑。

刊登研究方案有利于研究人员和资助机构及时了解相关领域中尚未广为人知的最新研究活动。这也有利于避免其他团队不必要的重复工作,并促进彼此的合作。此外,与仅按照试验注册的要求填写研究方案相比,全文刊登研究方案还能够使试验计划更为详尽透明,也能够使编辑、审稿人和读者更易于发现、理解试验中与方案不同的各种偏差。

研究方案的内容和结构详细要求,见这里

各种重要声明的要求同研究文章。

报告指南

SPIRIT规范(Standard Protocol Items for Randomized Trials,随机试验标准方案条款)。该规范是在对大量资源和共识进行系统综述后编制的循证工具。该标准中既借鉴了 CONSORT 声明,也强调了一些重要的伦理学问题。本刊鼓励作者在起草研究方案时遵循SPIRIT的建议。
需要提交Checklist
PRISMA-P(Preferred reporting items for systematic review and meta-analysis protocols,系统综述和荟萃分析研究方案建议写作条款)。
PRISMA-P核对清单列出了系统综述和荟萃分析研究方案的17个最基本的部分。强烈建议系统综述的作者和评价者在起草和评价综述方案时使用PRISMA-P。
需要提交Checklist
● 有多家机构提供权威的试验方案下载,如英国国家卫生/医学研究委员会提供的Clinical Trials Toolkit(临床试验操作规范)和美国国家卫生研究院提供的试验方案撰写指南等。BMJ Open接受任何设计类型的研究方案,包括观察性研究和系统综述。

强烈建议作者完成研究注册。对于临床试验来说,前瞻性注册是强制性的。点击此处查看BMJ认可的注册机构。建议系统综述在Prospero进行注册。


参考文献:

编辑政策-BMJ官网 (bmjchina.com.cn)

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 楼主| JEBM 发表于 2024-5-21 19:45:56 | 显示全部楼层
                    Clinical Research               
                                    What to submitWe consider all types of clinical research. Original studies can be submitted in any of our content types.
Preparing your submissionNature Medicine follows the recommendations from the International Committee of Medical Journal Editors (ICMJE) and the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network for registration and reporting clinical studies.
Registration
All interventional trials must be registered before enrollment of the first participant. Trial registration records must be available in a primary register of the WHO International Clinical Trials Registry Platform (ICTRP), in ClinicalTrials.gov, or in any publicly accessible database that meets the minimum 24-item trial registration dataset.
The trial number must be clearly indicated in the abstract and methods section of the manuscript. Trials with retrospective registration or with registration in a database that is not publicly accessible cannot be considered.
Study protocol
To enable proper assessment of the work by our editorial team and referees, we request that a copy of the approved study protocol, including the statistical analysis plan, be included with the initial submission. Sensitive content can be redacted. If the original protocol is in a language other than English, a translation should be provided. Any deviations from the plan indicated in the trial registry or study protocol must be justified.
Interim analyses
Interim analyses should be pre-specified in the study protocol. Preliminary analyses of ongoing clinical trials that have not been pre-specified must be justified and are considered on a case-by-case basis. Unplanned post-hoc or exploratory analyses should be clearly indicated as such in the abstract and manuscript text.
Reporting guidelines

  • Case reports or case series – if performed in the setting of a clinical trial evaluating effectiveness in a single patient, a CONSORT extension for N-of-1 trials must be provided; if treatment is provided outside a clinical trial (e.g., as compassionate use, or experimental observational study), authors must provide a statement that the research protocol was approved by IRB and ethics committees and participants gave written informed consent, according to CARE guidelines and in compliance with the Declaration of Helsinki principles.
  • Randomized trials must conform to CONSORT 2010 guidelines, and the CONSORT checklist should be submitted with the manuscript and other materials, including the protocol. Non-randomized trials are encouraged to use the CONSORT principles and framework in the reporting of the results. Reports that do not conform to the CONSORT guidelines may need to be revised before formal review.
  • Observational studies (cohort, case–control or cross-sectional designs) must be reported according to the STROBE statement.
  • Systematic reviews and meta-analyses must follow the PRISMA guidelines.
  • Studies reporting biomarkers in association with clinical outcomes should follow the STARD guidelines. For biomarker studies in oncology, we request that authors adhere to REMARK guidelines.
  • Epidemiology studies are encouraged to follow the recommendation in the GATHER statement.
Data sharing
In accordance with Nature Research policy, a Data Availability Statement (DAS) must be included with all original research manuscripts. Nature Medicine is committed to transparency in data availability, and we request that authors provide a clear statement summarizing what data is available, when and to whom, and how to access it, and clearly stating any restrictions to data access.
Following ICMJE recommendations, clinical trials that began enrolling participants 1 January 2019 and later must include a data sharing plan in the trial's registration. If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.
Competing interests
In the interests of transparency and to help readers form their own judgments of potential bias, Nature Research journals require authors to declare any competing financial and/or non-financial interests in relation to the work described. The corresponding author is responsible for submitting a competing interests statement on behalf of all authors of the paper.
The role of the sponsor in any stage of the study, including manuscript preparation, must be acknowledged.


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