Instructions for Study Protocol Authors

Instructions for Study Protocol authors

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

 Enabling researchers to obtain feedback on draft study protocols through peer review;  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;  Enabling funders and researchers to see what studies are underway and hence reduce duplication of research effort;  Enabling systematic reviewers to find trials, which may in turn reduce distortion of the evidence from publication bias;  Enabling patients to see what studies are underway that they may wish to volunteer for.

Publishing your study protocol in JCIM By publishing your study protocol in JCIM, 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 number included as the last line of the abstract.

Publishing your study protocol in JCIM does 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 to JCIM should 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 headed Background, Methods/Design,

1 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

2 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.

Figure legends (if any) Tables and captions (if any) 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.