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[文章类型] 论著(Articles):说明和临床研究文章的要求

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JEBM 发表于 2023-12-25 19:49:24 | 显示全部楼层 |阅读模式

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文章类型:


说明:


稿件来源:


写作要求:


建议供写作参考的文献



论著(Articles),又称为Original Article 或者 Original Research。

论著强调数据可靠。
CTONG专家组成员推荐的文章优先,推荐人必需阅读过论文签字推荐。最终发表将公布推荐人姓名。
按照国内情况,主要是回顾性数据文献。选择有代表性的文章加评论后刊出。

选择标准:
  • 有创新性、新颖,对于临床有指导意义或者是临床关注的方向。
  • 国际国内主要临床试验相关的周边研究
  • 中国创新药物的发展
  • 回顾性,样本量可不足,但写作尚佳。

JEBM特色:
  • JEBM将请审稿或者有关的专家或者学有专长的学者对文章进行评论和讨论。同时发布作者的回应。



投稿要点:
  • 摘要可以长至400-500左右。
  • 要求论著为中英文双语发表。达到能够国际网络检索和浏览全文的目标。


文章的要求:




原创性论著:可按前言、资料(对象)与方法、结果、讨论四部分的结构进行撰写。

前言应简要阐明研究设计的背景、采用的研究方法及拟达到的目的,需引用文献,以200~300字为宜。研究方法中应明确提出研究类型,研究类型的关键信息也需在摘要或题名中体现。具体内容包括:(1)临床研究或实验研究;(2)前瞻性研究或回顾性研究;(3)病例系列研究、病例对照研究、队列研究、非随机对照研究或随机对照研究。结果需与方法一一对应,避免出现评论性语句。讨论中出现的结果必须在结果部分有所表述。前瞻性临床试验研究可参照CONSORT报告规范撰写。



描述性文章(病例报告等):病例报告应选择诊治过程有特殊之处,能够为临床诊治同类病例提供启示的病例;避免进行罕见病例的简单累积。病例资料应详尽,包括主诉、现病史、既往史、体检、实验室检查、影像学检查、诊断、治疗方式、病理学检查、预后等。尤其是对诊断、治疗有重要参考意义的检查结果,需重点描述。有创新的治疗手段也应详述。讨论部分应结合病例的诊治特点进行简要点评,避免进行文献综述。
🌴论著 - 栏目和模板 - 阳光肺科 (yangmdt.com)
胸有朝阳 发表于 2023-12-29 00:39:33 | 显示全部楼层

《英国医学杂志》-BMJ官网 (bmjchina.com.cn)

以下参考自BMJ。



报告指南


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和Flow Diagram。
- 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Checklist和Flow Diagram。
● 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
- 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Checklist和Flow 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。



MJ  基本投稿要求

请确保您向The BMJ 递交的所有内容首先符合国际医学期刊编辑委员会(ICMJE)的建议(ICMJE Recommendations 2013)。同时,The BMJ 针对不同类型的文章有特定要求,尤其是研究型文章。强烈建议您仔细阅读。本篇为大家列出对The BMJ 所有投稿的基本要求。

● 所有文章适用 – 标题页,请按照本样例:Title page
● 所有文章适用 – 所有作者的姓名、地址和职位,以及通讯作者的邮件地址,并确保所列每位作者符合作者署名标准
● 所有文章适用 – 在文章中加入允许The BMJ 出版的版权声明
●  所有文章适用 – 声明所有作者的利益冲突,请按照本页的要求为您的文章类型选择相应的表格填写
● 原创性研究与教育类文章适用 – 列出所有贡献者(contributor)的详细信息与保证人(guarantor)的名字,如需要请参照本页关于Contributorship的解释  注:教育类文章包括clinical review,practice articles,state of the art reviews,Minerva pictures和Endgame
● 所有涉及患者私人信息的文章适用 – 提交签字的患者知情同意书,这里是模板
● 原创性研究文章适用 – 提交以下声明:伦理审查批准,受试者知情同意,资金,研究赞助方在研究设计、数据采集分析与解读、文章撰写以及投稿决定中的角色,研究者与资金和赞助方保持独立,研究者能看到所有数据
● RCT报告适用 – 提交按CONSORT guideline要求的checklist和flow diagram、试验方案(trial protocol)以及试验的详细注册信息。根据ICMJE的统一建议,2005年7月以后开始的临床试验必须在招募患者之前进行预注册(prospective registration);更老的临床试验可以接受后注册(retrospective registration),但必须在向期刊投稿前完成注册。



● 如您向The BMJ 投稿以下类型的文章,请分别参照:
    针对随机试验和其它评估研究的systematic review或meta-analysis,请使用PRISMA guidelines(注:已经取代QUOROM guidelines),如有研究方案(study protocol),请以补充材料的形式提交
    针对观察性研究的meta-analysis,请使用MOOSE guidelines,如有研究方案,请以补充材料的形式提交
    诊断精确性研究,请使用STARD guidelines
    观察性研究,请使用STROBE guidelines,如有研究方案,请以补充材料的形式提交
    临床指南的文章,建议参考GRADE给出的证据等级
    卫生经济学相关文章,请使用CHEERS statement


以上及其它报告指南都整理在EQUATOR Network。EQUATOR的意思即是通过推广透明、准确的医学研究报告来提高科学出版的质量。出于帮助所收投稿提高报告质量,并为审稿人提供更全信息的目的,我们要求研究文章的作者尽量遵守相关reporting guidelines的建议,并在投稿前(最晚于送审前)准备好相关reporting checklist。我们不会以此作为衡量研究质量或决定稿件去留的核心评价工具,但是希望您的研究文章尽可能清晰完整,以便相关人士(同行评审专家、期刊编辑、医生、教育工作者、伦理学家、政策制定者、系统性综述作者、指南编写者、记者、患者以及公共)了解研究过程中真正发生了什么。


我们偏好哪些研究? (Publish your research study)

优先考虑有潜力影响临床实践或卫生政策的优秀研究

The BMJ 是影响力深远的国际综合医学期刊,发表的研究来自所有医学专科,读者群体包括临床医生、研究者以及全世界卫生政策制定者。我们倾向于发表:
- 能够把科学发现(scientific discoveries)转化为实践应用(practical applications)的研究
- 能够帮助医生在诊疗与科研(clinic and research)、公共卫生(public health)和卫生政策制定(health policy setting)过程中做出更好决策的研究
因此,如果您的研究新颖(novel)、符合伦理道德(ethical)、研究方法可靠(methodologically robust),且所研究问题与临床诊疗(clinical care)、公共卫生或医疗政策(healthcare policy)直接相关,我们邀请您向The BMJ 投稿。

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也就是说 ,我们重视与患者和医生息息相关的研究,优先考虑具有“可执行性”(能改变医生诊疗患者的方式方法)的研究。负面结果的研究对证据库(evidence base)也有积极贡献,如果该研究设计合理、执行得当,且负面结果也能帮助医生做出更优的治疗决策,那该研究依然十分重要。除此以外,我们也对以下研究感兴趣:
- Examine robustly “why” and “how” doctors do things
- Explore how and why to offer services and specific types of care to patients
- Evaluate educational and quality improvement initiatives

同时,我们也发表讨论研究方法的文章。这类“Research Methods and Reporting”的文章可以描述创新的研究和分析方法,也可以描述如何报告研究数据的新方法。我们的目标是要推广高质量的临床研究。专门探讨研究方法的文章能够帮助研究者更好地进行研究设计与执行,从而产出更佳的证据。希望也能够帮助读者看懂研究结果,帮助编辑辨别高质量的研究。

The BMJ 提倡透明的编辑过程,完善同行评审机制。因此,我们也发表探讨学术期刊、作者群体、编辑群体行为规范的研究。The BMJ一再强调透明(transparency)的重要性,希望读者明白我们发表的研究值得信赖。

在做一篇研究文章的最终决策时,我们会考虑其国际影响力。如果您的研究可能改变医学实践、制定医疗热点、改善医学研究的执行或扩大研究的影响力,我们再一次鼓励您向The BMJ投稿。

有关The BMJ 偏好什么样的研究,该PDF为您提供了非常详细的checklist,如有需要请仔细阅读,提升您的稿件被接受的几率!另附中国作者在The BMJ 上发表的研究文章作为样例,供您参考。


杨学宁医师 发表于 2024-5-19 15:36:00 | 显示全部楼层
lancet参考
Peer reviewed reports of original research that are likely to change clinical practice, policy or substantially change thinking about a disease. These include interventional clinical trials, observational studies, modelling studies, and meta-analyses. Original research papers are always externally peer reviewed.



Content Types | Nature Medicine
An Article is a report of a complete new study in any area of translational or clinical medicine.
Format
  • Main text – up to 4,000 words, excluding abstract, Methods, references and figure legends.
  • Abstract – up to 150 words, unreferenced.
  • Display items – up to 6 items (figures and/or tables).
  • Article should be divided as follows:
    • Introduction (without heading)
    • Results
    • Discussion
    • Online Methods.
  • Results and online Methods should be divided by topical subheadings; the Discussion does not contain subheadings.
  • References –  as a guideline, we typically recommend up to 60.
  • Articles include received/accepted dates.
  • Articles may be accompanied by supplementary information.
  • Articles are peer reviewed.





Instructions for Authors | JAMA Oncology | JAMA Network
  
类型
  
说明
要求
Original Investigation
full info


Clinical trial
Meta-analysis
Intervention study
Cohort study
Case-control study
Epidemiologic assessment
Survey with high response rate
Cost-effectiveness analysis
Decision analysis
Study of screening and diagnostic tests
Other observational study

-----
-Brief Report
full info

-Short reports of original studies or evaluations or unique, first-time reports of clinical case series.
It is very rare for this journal to publish case reports.

-
-Research Letter
full info

-Concise, focused reports of original research. Can include any of the study types listed under Original Investigation.
-
-
-
-
-
-
-

Original Investigation
These reports typically include randomized trials (see Clinical Trial), intervention studies, cohort studies, case-control studies, epidemiologic assessments, other observational studies, surveys with high response rates (see Reports of Survey Research), cost-effectiveness analyses and decision analyses (see Reports of Cost-effectiveness Analyses and Decision Analyses), and studies of screening and diagnostic tests (see also Reports of Diagnostic Tests). A study type is required. Each manuscript should clearly state an objective or hypothesis; the design and methods (including the study type and setting and dates, patients or participants with inclusion and exclusion criteria and/or participation or response rates, or data sources, and how these were selected for the study); the essential features of any interventions; the main outcome measures; the main results of the study; a discussion section placing the results in context with the published literature and addressing study limitations; and the conclusions and relevant implications for clinical practice or health policy. Data included in research reports must be original and should be as timely and current as possible (see Timeliness of Data). Follow EQUATOR Reporting Guidelines.
A structured abstract is required; for more information, see instructions for preparing Abstracts for Reports of Original Data. A list of 3 Key Points is required (see guidance on preparing Key Points). Maximum length: 3000 words of text (not including abstract, tables, figures, acknowledgments, references, and online-only material) with no more than a total of 5 tables and/or figures.


Brief Report
These manuscripts are short reports of original studies or evaluations or unique, first-time reports of clinical case series. Follow EQUATOR Reporting Guidelines. A structured abstract is required; for more information, see instructions for preparing Abstracts for Reports of Original Data. A list of 3 Key Points is required (see guidance on preparing Key Points). Recommended length: 1200 words (not including abstract, tables, figures, acknowledgments, references, and online-only material) with no more than a total of 3 tables and/or figures and no more than 15 references. Note: It is very rare for this journal to publish case reports.


Brief Communication
Content Types | Nature Medicine

A Brief Communication is a format intended for reporting of timely new results that, while limited in scope, are of substantial clinical or public health importance, and that therefore need to be quickly vetted and shared.
Format
  • Abstract – up to 150 words, unreferenced.
  • Main text – up to 2,000 words, including abstract, references and figure legends, and contains no headings.
  • Display items – up to 2 items, although this may be flexible at the discretion of the editor, provided the page limit is observed.
  • Online Methods section should be included.
  • References - as a guideline, we typically recommend up to 20. Article titles are omitted from the reference list.
  • Brief Communications should include received/accepted dates.
  • Brief Communications may be accompanied by supplementary information.
  • Brief Communications are peer reviewed.



Research Letter
Research Letters are concise, focused reports of original research. These should not exceed 600 words of text and 6 references and may include up to 2 tables or figures. Online supplementary material is only allowed for brief additional and absolutely necessary methods but not for any additional results or discussion. Research Letters may have no more than 7 authors. The text should include the full name, academic degrees, and a single institutional affiliation for each author and the email address for the corresponding author. Other persons who have contributed to the study may be indicated in an Acknowledgment, with their permission, including their academic degrees, affiliation, contribution to the study, and an indication if compensation was received for their role. Letters must not duplicate other material published or submitted for publication. In general, Research Letters should be divided into the following sections: Introduction, Methods, Results, and Discussion. They should not include an abstract or key points, but otherwise should follow all of the guidelines in Manuscript Preparation and Submission Requirements. Letters not meeting these specifications are generally not considered.



Specific Components of a Systematic Review
Key Points (75-100 words)
This feature provides a quick structured synopsis of the Review, following 3 key points: Question, Findings, and Meaning. Limit to no more than 100 words. This is different from the Abstract.
Example
Question: What are the most effective medical treatments for adult chronic sinusitis?
Findings: In this systematic review, symptoms of chronic sinusitis were improved with saline irrigation and topical corticosteroid therapy compared to no therapy. Compared with placebo, 3-week courses of systemic corticosteroids or oral doxycycline were associated with reduced polyp size, and a 3-month course of macrolide antibiotic was associated with improved symptoms in patients without polyps.
Meaning: First-line therapy for chronic sinusitis should begin with daily topical intranasal corticosteroid in conjunction with saline irrigation; subsequent therapies should be based on the patient's polyp status and severity of symptoms.
Abstract (350 words)
A structured abstract is required; Systematic Review articles should include a structured abstract of no more than 350 words using the headings listed below.
Importance: Include 1 or 2 sentences describing the clinical question or issue and its importance in clinical practice or public health.
Objective: State the precise primary objective of the review. Indicate whether the review emphasizes factors such as cause, diagnosis, prognosis, therapy, or prevention and include information about the specific population, intervention, exposure, and tests or outcomes that are being reviewed.
Evidence Review: Describe the information sources used, including the search strategies, years searched, and other sources of material, such as subsequent reference searches of retrieved articles. Methods used for inclusion of identified articles and quality assessment should be explained.
Findings: Include a brief summary of the number of articles included, numbers of various types of studies (eg, clinical trials, cohort studies), and numbers of patients/participants represented by these studies. Summarize the major findings of the review of the clinical issue or topic in an evidence-based, objective, and balanced fashion, with the highest-quality evidence available receiving the greatest emphasis. Provide quantitative data.
Conclusions and Relevance: The conclusions should clearly answer the questions posed if applicable, be based on available evidence, and emphasize how clinicians should apply current knowledge. Conclusions should be based only on results described in the abstract Findings subsection.
Introduction (150-250 words)
The first 2 to 3 sentences of the Introduction should draw in readers such that they want to continue reading the article and should establish the importance of the Review. Reviews should include the clinical question or issue and its importance for general medical practice, specialty practice, or public health. The first paragraph should provide a general summary of the clinical problem (eg, obesity). The next paragraph should focus on the specific aspect of the clinical problem the article will explore (eg, treatments for obesity). The epidemiology of the disease or condition should be briefly summarized and generally should include disease prevalence and incidence. The third paragraph should discuss exactly what material will be covered in the Review (eg, obesity treatments reported in trials with a minimum follow-up of 2 years including 80% of the original cohort).
Methods/Literature Search (150-250 words)
The literature search should be as current as possible, ideally with end dates within a month or two before manuscript submission. A search of the primary literature should be conducted, including multiple bibliographic databases (eg, PubMed/MEDLINE, Embase, CINAHL, PsycINFO). This can be facilitated by collaborating with a medical librarian to help with the search.
Briefly describe characteristics of the literature searched and included in the review, following the PRISMA reporting guidelines, including the bibliographic databases and other sources searched, search terms used, dates included in the search, date the literature search was conducted, screening process, language limitations, and inclusion and exclusion criteria. The rating system used to evaluate the quality of the evidence should be specified (see table below) and the methods used to evaluate quality should be described, including number of quality raters, how agreement on quality ratings was assessed, and how disagreements on quality ratings were resolved.
The highest-quality evidence (eg, randomized clinical trials, meta-analyses, systematic reviews, and high-quality prospective cohort studies) should receive the greatest emphasis. Clinical practice guidelines ordinarily should not be used as a primary component of the evidence base for the systematic review, although relevant guidelines should be addressed in the Discussion section of the article.
The search methods should be described in sufficient detail so the search can be reproduced based on the information provided in the manuscript. A summary of the methods of the literature search including this information should be included in the main article; details can be included in an online-only supplement. A PRISMA-style flow diagram showing this information should also be included as an online-only supplement. In addition, a completed PRISMA checklist should be submitted for the items completed that apply to systematic reviews (the checklist items that apply to meta-analyses do not need to be completed for systematic reviews without meta-analysis). The checklist will be used during review but will not be published.
Results (1000-1250 words)
First, briefly report the results of the literature search, including the number of articles reviewed and included, numbers of various types of studies (eg, clinical trials, cohort studies) included, and the aggregate numbers of patients included in the reviewed studies. Also provide a brief summary of the quality of the evidence. Details of this information can be included in a PRISMA-style flow diagram and table(s).
Next, the subsections listed below should generally appear in the Results sections of most Reviews although all of these subsections may not be necessary for some topics, depending on the specific question or issue addressed. The word counts following each subsection are suggested to assist with keeping the overall Results section limited to 1000-1250 words.
Pathophysiology (150-250 words). Provide a brief overview of the pathophysiology of the disease. The intent is to provide readers with sufficient background information about the underpinnings of a disease to provide context for the rest of the article.
Clinical Presentation (150-250 words). Briefly describe the clinical characteristics that result in a patient seeking medical care for the condition or what features of the disease should lead a clinician to evaluate or treat it.
Assessment and Diagnosis (250-300 words). Describe the clinical examination for evaluation of the disease and explain the most salient physical examination findings. If laboratory or imaging studies are necessary, provide the sensitivity and specificity and diagnostic accuracy of these tests and consider providing positive and negative likelihood ratios. Sequences of diagnostic tests are best presented as algorithms or in tables.
Treatment (250-500 words). Treatments should be based on the most recently available and highest level of evidence. Treatment options should be summarized in the text and presented in detail in tables along with an indication of the strength of evidence supporting the individual treatments. In general, treatment recommendations should be supported by a systematic review of the literature, either performed by the author of the Review or published in the form of a high-quality review or guideline. If possible, the costs for various treatments should be provided.
Prognosis (100-150 words). A section outlining the overall prognosis for the condition, once treated, should be included.
Discussion (Approximately 1000 words)
Key findings should be summarized in the first paragraph of the Discussion section. All statements made should be supported by evidence. It is very important to not simply list findings from the studies reviewed. This information is best presented in tables. The Discussion should provide a critical synthesis of data and information based on the results of the review, an assessment of the quality of studies summarized, and a description of how studies can be interpreted and used to guide clinical practice. The limitations of the evidence and of the review should be discussed, and gaps in evidence should be addressed. A discussion of controversial or unresolved issues and topics in need of future research also should be included.
Clinical Practice Guidelines: In the Discussion section, describe current clinical practice guidelines, relevant to the topic of the review, if available, and whether the conclusions of this review agree with, or disagree with, the current clinical practice guidelines. If this is done and there is more than 1 guideline, a table should be prepared comparing the major features that differ between the guidelines. Guideline quality should be discussed using the standards outlined for the JAMA Clinical Guidelines Synopsis.
Conclusions
Include a 2- to 3-sentence summary of the major conclusions of the review.
Tables
Construct tables that summarize the search results. Tables summarizing treatments should have information organized by category of treatment and then by individual treatments. Columns should include the name of the treatment, strength of evidence supporting the treatment, the treatment's effect (preferably shown as the treatment's effect as compared to control on the measured outcome together with 95% confidence intervals), adverse effects, and very brief comments, if necessary. Lengthy text-based tables should be avoided. Additional or lengthy tables may be published online only, if justified.

Ratings of the quality of the evidence. Tables summarizing evidence should include ratings of the quality of the evidence. Use the rating scheme listed below with ratings of 1-5 for Reviews that include individual studies (modified from the Oxford Centre for Evidence-based Medicine for ratings of individual studies).
Quality Rating Scheme for Studies and Other Evidence
1Properly powered and conducted randomized clinical trial; systematic review with meta-analysis
2Well-designed controlled trial without randomization; prospective comparative cohort trial
3Case-control studies; retrospective cohort study
4Case series with or without intervention; cross-sectional study
5Opinion of respected authorities; case reports

There are several other preferred systems for rating the quality of evidence in Review articles. For Reviews that synthesize findings from numerous studies into a single summary recommendation, use the rating scale shown above or the Oxford Centre for Evidence-based Medicine's Levels of Evidence and Grades of Recommendation or the recommendations in the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. For reviews that include diagnostic studies, use The Rational Clinical Examination Levels of Evidence table.
Follow additional instructions for preparation and submission of Tables.

Figures
A PRISMA-style flow diagram should be included as an online supplement that summarizes the results of the literature search and the numbers of articles/records/studies and patients/participants represented in the studies identified, screened, eligible, and included in the final review.

Additional figures that illustrate pathophysiology or clinical presentation may be considered. We encourage videos, if appropriate, to illustrate a point made or process described in the Review.
Follow additional instructions for preparation and submission of Figures and Video.


Clinical Trial
These manuscripts include reports of Randomized Clinical Trials, Parallel-Design Double-blind Trials, Crossover Trials, Equivalence and Noninferiority Trials, Cluster Trials, and Nonrandomized Controlled Trials.
The ICMJE defines a clinical trial as any research project that prospectively assigns human participants to intervention or comparison groups to study the cause-and-effect relationship between an intervention and a health outcome.4 Interventions include but are not limited to drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, process-of-care changes, and the like. All manuscripts reporting clinical trials, including those limited to secondary exploratory or post hoc analysis of trial outcomes, must include the following:
  • Copy of the original trial protocol, including the complete statistical analysis plan and any amendments. The journal recommends using the SPIRIT reporting guidelines when preparing original protocols (see Protocols).
  • CONSORT flow diagram (see Figure).
  • Completed trial checklist (see Checklist).
  • Registry at an appropriate online public clinical trial registry (see Trial Registration requirements).
  • A Data Sharing Statement to indicate if data will be shared or not. Specific questions regarding the sharing of data are included in the manuscript submission system.
For additional guidance on reporting Randomized Clinical Trial, Parallel-Design Double-blind Trial, Crossover Trial, Equivalence and Noninferiority Trial, Cluster Trial, and Nonrandomized Controlled Trial, see Study Types.
Each manuscript should clearly state an objective or hypothesis; the design and methods (including the study setting and dates, patients or participants with inclusion and exclusion criteria, or data sources, and how these were selected for the study); the essential features of any interventions; the primary and secondary outcome measures (consistent with those reported in the trial protocol); the main results of the study; a discussion section placing the results in context with the published literature and addressing study limitations; and the conclusions.
A structured abstract is required, and trial registration information (registry name, trial ID, and URL) must be listed at the end of the abstract; for more information, see instructions for preparing Abstracts for Reports of Original Data. A list of 3 Key Points is required (see guidance on preparing Key Points). Maximum length: 3000 words of text (not including abstract, tables, figures, acknowledgments, references, and supplemental material) with no more than a total of 5 tables and/or figures and no more than 50-75 references. The subtitle should include the phrase "A Randomized Clinical Trial" or, for Nonrandomized Controlled Trials, "A Nonrandomized Controlled Trial." To read more about clinical trials, see the AMA Manual of Style.
Trial Registration:
In concert with the ICMJE, JAMA Network requires, as a condition of consideration for publication, registration of all trials in a public trials registry that is acceptable to the ICMJE (ie, the registry must be owned by a not-for-profit entity, be publicly accessible, and require the minimum registration data set as described by ICMJE).4,8,9
Acceptable trial registries include the following and others listed at http://www.icmje.org:
  • anzctr.org.au
  • clinicaltrials.gov
  • isrctn.org
  • trialregister.nl
  • umin.ac.jp/ctr
All clinical trials, regardless of when they were completed, and secondary analyses of original clinical trials must be registered before submission of a manuscript based on the trial. Secondary data analyses of primary (parent) clinical trials should not be registered as separate clinical trials, but instead should reference the trial registration number of the primary trial. Please note: for clinical trials starting patient enrollment after July 2005, trials must have been registered before onset of patient enrollment. For trials that began before July 2005 but that were not registered before September 13, 2005, trials must have been registered before journal submission. Trial registry name, registration identification number, and the URL for the registry should be included at the end of the abstract and also in the space provided on the online manuscript submission form.
Protocols:
Authors of manuscripts reporting clinical trials must submit trial protocols (including the complete statistical analysis plan) along with their manuscripts. Protocols in non-English languages should be translated into English. This should include the original approved protocol and statistical analysis plan, and all subsequent amendments to either document. Do not submit a summary version that was published as an article in another journal. If the manuscript is accepted, the protocol and statistical analysis plan will be published as a supplement.
CONSORT Flow Diagram and Checklist:
Manuscripts reporting the results of randomized trials must include the CONSORT flow diagram showing the progress of patients throughout the trial. The CONSORT checklist also should be completed and submitted with the manuscript.10
Figure. Profile of a Randomized Clinical Trial 截图202405211245483287.png

Trial Protocol
These manuscripts are documents that describe the organization and plan for a randomized clinical trial, including the trial's objective(s), design, methodology, all outcomes to be measured, and statistical analysis plan. All trial protocol manuscripts must include a copy of the trial protocol including the complete statistical analysis plan (see Protocols). All clinical trials that have begun randomization must be registered at an appropriate online public registry (see Trial Registration requirements). Follow SPIRIT Reporting Guidelines.
A structured abstract is required, and trial registration information (registry name, trial ID, and URL) must be listed at the end of the abstract; for more information, see instructions for preparing Abstracts for Trial Protocols. A list of 3 Key Points is required (see guidance on preparing Key Points). Maximum length: 3000 words of text (not including abstract, tables, figures, acknowledgments, references, and supplemental material) with no more than a total of 5 tables and/or figures and no more than 50-75 references. The subtitle should include the phrase "A Trial Protocol."

Meta-analysis
These manuscripts are systematic, critical assessments of literature and data sources pertaining to clinical topics, emphasizing factors such as cause, diagnosis, prognosis, therapy, or prevention, and that includes a statistical technique for quantitatively combining the results of multiple studies that measure the same outcome into a single pooled or summary estimate. All articles or data sources should be searched for and selected systematically for inclusion and critically evaluated, and the search and selection process should be described in the manuscript. The specific type of study or analysis, population, intervention, exposure, and tests or outcomes should be described for each article or data source. The data sources should be as current as possible, ideally with the search having been conducted within several months of manuscript submission. Authors of reports of meta-analyses of clinical trials should submit the PRISMA flow diagram and checklist. Authors of meta-analyses of observational studies should submit the MOOSE checklist. Follow EQUATOR Reporting Guidelines.
A structured abstract is required; for more information, see instructions for preparing Abstracts for Meta-analysis. A list of 3 Key Points is required (see guidance on preparing Key Points). Maximum length: 3000 words of text (not including abstract, tables, figures, acknowledgments, references, and online-only material), with no more than a total of 5 tables and/or figures and no more than 50-75 references. The subtitle should include the phrase "A Meta-analysis." To read more about meta-analyses, see the AMA Manual of Style.

Other Observational Studies
These manuscripts include Cohort Study, Case-Control Study, Cross-sectional Study, Case Series, Economic Evaluation, Decision Analytical Model, Comparative Effectiveness Research, Genetic Association Study, Diagnostic/Prognostic Study, Quality Improvement Study, Survey Study, and Qualitative Study. Each manuscript should clearly state an objective or hypothesis; the design and methods (including the study setting and dates, patients or participants with inclusion and exclusion criteria and/or participation or response rates, or data sources, and how these were selected for the study); the essential features of any interventions or exposures; the main outcome measures; the main results of the study; a discussion section placing the results in context with the published literature and addressing study limitations; and the conclusions and relevant implications for clinical practice or health policy. Data included in research reports must be original and should be as timely and current as possible (see Timeliness of Data). Follow EQUATOR Reporting Guidelines.
A structured abstract is required; for more information, see instructions for preparing Abstracts for Reports of Original Data. A list of 3 Key Points is required (see guidance on preparing Key Points). Maximum length: 3000 words of text (not including abstract, tables, figures, acknowledgments, references, and supplemental material) with no more than a total of 5 tables and/or figures and no more than 50-75 references.





Resource
A Resource presents a large data set of broad utility, interest and significance to the community.
Format
  • Main text – up to 4,000 words (excluding abstract, online Methods, references and figure legends).
  • Abstract – 150 words, unreferenced.
  • Display items – up to 6 items (figures and/or tables).
  • Resource should be divided as follows:
    • Introduction (without heading)
    • Results
    • Discussion
    • Online Methods.
  • Results and online Methods should be divided by topical subheadings; the Discussion does not contain subheadings.
  • References – as a guideline, we typically recommend up to 60.
  • Resources include received/accepted dates.
  • Resources may be accompanied by supplementary information.
  • Resources are peer reviewed.





Analysis
Content Types | Nature Medicine

An Analysis is a new analysis of existing data (typically large genomic, transcriptomic or proteomic data sets, or meta-analyses of clinical studies) that lead to novel and arresting conclusions of importance to a broad audience.
Format
  • Main text – up to 4,000 words (excluding abstract, online Methods, references and figure legends).
  • Abstract – 150 words, unreferenced.
  • Display items – up to 6 items (figures and/or tables).
  • Resource should be divided as follows:
    • Introduction (without heading)
    • Results
    • Discussion
    • Online Methods.
  • Results and online Methods should be divided by topical subheadings; the Discussion does not contain subheadings.
  • References – as a guideline, we typically recommend up to 60.
  • Analyses include received/accepted dates.
  • Analyses may be accompanied by supplementary information.
  • Analyses are peer reviewed.



For Authors : Preparing your manuscript (thelancet.com)

ObservationalGuidelines-1688712280923.pdf (thelancet.com)

metaguidelines-1668613510077.pdf (thelancet.com)

RCTguidelines-1668613849943.pdf (thelancet.com)

artwork-guidelines-1688984488897.pdf (thelancet.com)




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 楼主| JEBM 发表于 2024-5-22 23:54:05 | 显示全部楼层
原创性研究文章 Original Papers
报告原始数据的文章(如对照试验和干预研究所获结果)需注意:正文:不超过 4000 个单词
结构性摘要:不超过 250 个单词


图表:所提交的图片必须能够特异性说明文中涉及数据,且不得重复正文或表格中的信息。图片数量不限,但也并非多多益善,只能在必要时出现。
参考文献:仅限与本文密切相关的重点文献(约 50 篇)。
作者还应填写一份“概要”(summary),阐明本研究的意义。该概要将以框图形式在文内刊出,其内容包括:
本研究的背景是什么?(What is already knownabout this subject?):3-4 本研究有何新发现?(What are the new findings?):3-4
本研究在不久的将来会对临床实践产生哪些影响?(How might it impact on clinical practice in the foreseeablefuture?)
针对随机对照试验的报告应尽量遵循JAMA(2001;285:1987-91)发布的修订后的 CONSORT 声明(临床试验报告统一标准)。更多指南信息请参阅 RCTs
部分原创性研究论文依据的是在脊椎动物和/或高等无脊椎动物中开展的实验。对于此类稿件,我们建议作者参照《ARRIVE 报告指南》。 该指南于 2010 年 6 月发表在
《PLoS Biology》(纯在线版期刊),目前已被 40 多家重点期刊所采纳(这些期刊的完整目录见此)。
标题页
在选择标题时,应切记读者将通过书目检索的方式找到你的作品。请核对文章的标题是否能很好地概括文章的内容,且不会造成误导。此外,作者应列出眉题。
此外,应参照本刊的体例格式,在标题页列出标题和作者姓名。如果作者的本名的数量或使用的缩写不一致,将导致索引中出现的作者姓名有多个版本。Gut 不刊载作者的学位等信息。
摘要
研究文章必须提供结构式摘要,长度不超过 250 个单词,并使用以下小标题:
1.        目的
2.        设计
3.        结果
4.        结论 详见体例格式说明


杨学宁 发表于 2024-7-3 14:00:07 | 显示全部楼层
综述、Meta分析、系统综述:

Meta分析需严格选择符合要求的文献(临床随机对照研究)进行分析,有严格的选择与剔除标准,主题选择得当,方法科学严谨。检索数据库遴选全面、具有代表性,文献来源期刊也要进行适当遴选。

系统综述是针对某一领域的具体问题(采用国际通用PICO格式方法明确研究问题,即患者patient,干预措施intervention,对照措施comparison和结局指标outcome),全面检索当前可得的最佳研究证据,并对纳入研究进行质量评价的一种合成研究(根据情况可对数据进行Meta分析合并,也可仅作描述)的方法。可参照PRISMA报告规范进行撰写。
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