“研究方案”作者投稿须知

《中西医结合学报》将于2011年开设一个新的栏目——研究方案，欢迎广大作者及读者踊跃投稿。投稿作者请登陆《中西医结合学报》网站http://www.jcimjournal.com，使用本刊ScholarOne Manuscripts在线投稿系统完成投稿，投稿时请在稿件类型选项中选择“研究方案（Study Protocol）”。

在本刊发表的研究方案将会成为一篇可被全文引用的开放获取文章，同时还将被收录于PubMed。本刊所接收的研究方案可以是计划中的研究或者是正在进行中的研究。如果该研究获得了相关伦理委员会审查通过并由较大规模的基金支持（需提供证明），则通常这类研究方案不再需要同行评议；而没有基金支持或未经伦理委员会审查的研究方案将需要通过同行评议才能考虑被本刊录用。作者在投稿时应该提供伦理审查和基金资助情况的证明。

随机对照试验的研究方案应遵照CONSORT声明的要求，并需要在摘要的最后提供临床试验注册号码。

在本刊发表研究方案的作者不一定要将其后期的研究结果投递至本刊，但本刊将十分欢迎这些后续投稿。

研究方案应提供该研究设计的假设、主要论据及方法学。研究方案的撰写应按顺序分为以下几个部分：

文题页

请在文题页中列出文章题目及所有作者的全名、单位地址及E-mail，并需指明通讯作者。

摘要

按照结构式摘要的格式，应将摘要分为“背景、方法/设计、讨论、临床试验注册”等几部分。如果所投递的研究方案为对照干预的临床设计方案，则需要在摘要最后提供临床试验注册的相关信息及临床试验注册号码，如“Trial registration: Current Controlled Trials ISRCTN73824458”。请注意不要在临床试验注册号码的字母和数字间键入任何空格或其他字母。请注意在摘要内不要使用缩写或标注参考文献。

背景及研究意义/前期研究

请在这一部分描述开展本研究的研究背景，阐述所要解决的问题（需附相关参考文献）并对当前的相关文献做一回顾。请对与本研究相关的前期研究及现有资料做一客观的评价，并阐明本研究如何能提高对相关领域的认识和拓展。

研究目的

请在这一部分描述本研究的研究目的，主要的研究目标或假设，必要的话描述本研究的次要目的。

研究设计及方法

该部分应概括以下内容：试验设计（如采用何种盲法）；研究对象的大致描述；干预及对照措施的详细描述；样本量的确定及把握度分析；研究结果或主要结局指标。

讨论

该部分可讨论在研究中所遇到的各种实际的或操作性的问题，或其他一切没有在前两部分中涉及的问题。

致谢及基金项目

请在致谢部分对所有对该研究作出过重要贡献或提供了重要帮助的个人或机构表示感谢。在致谢的同时需要提及这些个人或机构所提供帮助的资金来源。作者在致谢时需要得到被致谢人允许在文章“致谢”中提及其姓名的许可。

请在这一部分一并提及研究或作者个人所获得的基金资助。作者有必要阐明资助机构在研究的设计，数据的收集、分析和解释，文章的撰写以及稿件的投递和发表等各方面所产生的影响。

利益冲突

请在这一部分公开任何与研究或任一作者有关的财务或非财务方面的利益冲突，以免这些利益冲突在文章发表后为作者带来不必要的麻烦和尴尬。作者需要公开一份利益冲突声明，所有被公开的利益冲突将被列于文章结尾处。如果作者没有任何利益冲突需要公布，则在文章结尾处需做如下声明“作者声明不存在任何利益冲突（The author(s) declare that they have no competing interests）”。

作者贡献

请将文中每一作者对研究的分工和贡献列于此处。

参考文献

文中所有参考文献请按其在正文、表格或图表说明中出现的顺序依次编号。请不要在文章题目或图表标题处添加参考文献。没一条参考文献要有其唯一的序号。

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Instructions for Study Protocol authors

Journal of Chinese Integrative Medicine(JCIM) will publish a new section for Study Protocol.JCIMbelieves that publishing clinical study protocols will help improve the standard of medical research by:

l Enabling researchers to obtain feedback on draft study protocols through peer review;

l Enabling readers to compare what was originally intended with what was actually done, thus preventing both "data dredging" and post-hoc revisions of study aims;

l Enabling funders and researchers to see what studies are underway and hence reduce duplication of research effort;

l Enabling systematic reviewers to find trials, which may in turn reduce distortion of the evidence from publication bias;

l Enabling patients to see what studies are underway that they may wish to volunteer for.

Publishing your study protocol inJCIM

By publishing your study protocol inJCIM, it becomes a fully citable open-access article—freely and universally accessible online, permanently archived. It will also be included in PubMed, further increasing its visibility.

The study protocol can be for proposed or ongoing research. Study protocols will usually be published without peer review if the study has received ethics approval and a grant from a major funding body (proof will be required). Study protocols without funding or ethical approval will be peer reviewed. Proof of both ethics and funding will be required and we recommend that authors provide the relevant documentation on submission.

Protocols of randomized controlled trials should follow the CONSORT guidelines and must have a trial registration numberincluded as the last line of the abstract.

Publishing your study protocol inJCIMdoes not commit you to submitting subsequent reports of the study to us, although we do, of course, welcome such submissions.

Protocols should provide a detailed account of the hypothesis, rationale and methodology of the study. Manuscripts for Study Protocol articles submitted toJCIMshould be divided into the following sections:

Protocol Outline

Title Page

This should list the title of the article and the full names, institutional addresses and e-mail addresses for all authors. The corresponding author should also be indicated.

Abstract

The abstract should be structured into separate sections headedBackground, Methods/Design, Discussion,Trial Registration. If your study protocol is a protocol of a controlled health care intervention, please list the trial registry, along with the unique identifying number, e.g. Trial registration: Current Controlled Trials ISRCTN73824458. Please note that there should be no space between the letters and numbers of your trial registration number. Please do not use abbreviations or references in the abstract.

Background and Significance/Preliminary Studies

Describe the current environment that is the basis for the proposed research, including a presentation of the problem (with references) and a review of current literature. Include a critical evaluation of current knowledge and preliminary studies related to the proposed research and describe how this proposal will enhance this knowledge.

Study Aims

Describe the purpose of the study, including identification of specific primary objectives/hypotheses. Secondary objectives/hypotheses should be described as necessary.

Study Design/Methods

a. Experimental design of the study (e.g., single-blind, double-blind)

b. General description of study population

c. A clear description of all interventions and comparisons,

d. Sample size determination and power analyses

e. Study outcomes/endpoints

Discussion

This can include discussion of any practical or operational issues involved in performing the study, and any other issues linked to the study that do not fall within the previous two headings.

Acknowledgements and Funding

Please acknowledge anyone who contributed towards the study by making substantial contributions to conception, design, acquisition of data, or analysis and interpretation of data, or who was involved in drafting the manuscript or revising it critically for important intellectual content, but who does not meet the criteria for authorship. Please also include their source(s) of funding. Please also acknowledge anyone who contributed materials essential for the study. Authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements.

Please list the source(s) of funding for the study, for each author, and for the manuscript preparation in the acknowledgements section. Authors must describe the role of the funding body, if any, in study design; in the collection, analysis, and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.

Competing interests

A competing interest exists when your interpretation of data or presentation of information may be influenced by your personal or financial relationship with other people or organizations. Authors should disclose any financial competing interests but also any non-financial competing interests that may cause them embarrassment were they to become public after the publication of the manuscript. Authors are required to complete a declaration of competing interests. All competing interests that are declared will be listed at the end of published articles. Where an author gives no competing interests, the listing will read “The author(s) declare that they have no competing interests.”

Authors' contributions

In order to give appropriate credit to each author of a paper, the individual contributions of authors to the manuscript should be specified in this section.

References

All references must be numbered consecutively in the order in which they are cited in the text, tables or legends. Reference citations should not appear in titles or headings. Each reference must have an individual reference number.

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Description of additional data files(if any)

Please submit your manuscript at the website of JCIM (http://www.jcimjournal.com) via ScholarOne Manuscripts submitting system.