Clinical Medicine manuscripts — first submissions

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• Reports of interest
  • Clinical trials
  • Observational analyses
• Formatting requirements
• Content of Clinical Medicine manuscripts

Reports of interest

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• Clinical trials

  • Reporting requirements for clinical trials

    • In accordance with Uniform Requirements for Manuscripts Submitted to Biomedical Journals, issued by the International Committee for Medical Journal Editors (ICMJE), authors must provide specific information regarding the ethical treatment of research participants, patient consent, patient privacy, protocols, authorship, and competing interests.
    • The Editors recommend that authors consult the Equator Network for a list of reporting guidelines for each study type.
    • The Journal encourages (but does not require) authors to submit the protocols associated with their studies in the supplemental material.
      • In Methods, indicate where study protocols can be accessed (e.g., provide a URL).

  • Required supporting materials for clinical trials

    • Conflict of interest documentation: ICMJE uniform disclosure form are required for all authors and should be uploaded as supplemental material
    • Clinical trial registry and trial registration number
    • Declaration of institutional review board approval and informed patient consent
    • Flow diagrams and checklists appropriate to study type: include the appropriate flow diagram as a figure in the manuscript and the corresponding checklist in the supplemental material.
      • Randomized controlled trials (RCTs): CONSORT checklist and flow diagram. If appropriate, the CONSORT Checklist for Reporting of Harms in RCTs should be consulted.
      • Nonrandomized studies (NRSs): Transparent Reporting of Evaluations with Nonrandomized Designs (TREND)

• Observational analyses

  • The Journal defines observational studies as those in which the investigator observes the effect a therapeutic or risk factor without intervention.
  • Trial registration. While registration is not required for all observational studies under ICMJE guidelines, the Editors encourage authors to register with any of the trial registries approved by the World Health Organization (WHO).
  • Reporting guidelines. Trial authors must adhere to STROBE statement reporting guidelines. Visit the STROBE statement website for information concerning specific study types, including observational studies in epidemiology, genetic association studies, biomarker studies, cohort studies, case-control studies, and cross-sectional studies.
  • Authors of observational studies should include a flow diagrams describing the study design and included patients.

Formatting requirements for Clinical Medicine manuscripts

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• Recommended length, 9,000 words; maximum, 12,000 (all text inclusive of title page, full text, references, figure legends, and tables).
• Double-spacing throughout, including references and tables; figure legends may be single spaced if necessary to keep a figure and its legend on the same page.
• All pages are numbered.
• Standard JCI Insight abbreviations and acronyms may be used without definition; all others are defined at first mention (with the abbreviated form appearing in parentheses) and used without definition thereafter.
• Gene and protein names and symbols conform to official NCBI Gene Nomenclature and are presented according to Journal style.

Note: After reviewing this section, authors are strongly encouraged to read Editorial policies and practices.

Content of Clinical Medicine manuscripts

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Ensure that each section begins on a new page.

• Title page

  • Manuscript title
  • • Clear, concise, and limited to 15 words, including conjunctions
    • Refers to the relevant disease or disease model studied
    • No subtitles, colons, periods, or nonstandard abbreviations
  • Authors and affiliations
    • Full names of all authors (for example, “Jane L. Doe”); no titles, honorifics, degrees, or certifications
    • List of authors’ affiliations (departments, institutions, and locations, but not mailing addresses) during the period when the work was performed.
    • Affiliation footnotes assigned consecutively using superscript numbers (1, 2, 3, etc.)
    • Corresponding author’s complete name, address, telephone number (including country code, where applicable), and email address.
    • Consortium/study groups shown as authors (e.g., CARDIoGRAM Consortium): Unless the members of each group appear as authors, list each individual member and their affiliation in the supplemental material.
    • In an unnumbered footnote, clearly indicate any instances of shared senior or first authorship or of equal contributions.
    • For manuscripts with 2 or more co–first authors, state the method used to assign the authorship order among these authors in Author contributions.
  • Conflict-of-interest statement
    • A statement consistent with the Journal's conflict-of-interest policy. If no author has a conflict, state: “The authors have declared that no conflict of interest exists.”

• Structured abstract

  • Maximum 250 words
  • Study information summarized in the following sections:
    • Background. Provide context or background for the study and state the study’s primary objective or hypothesis in 1–2 sentences.
    • Methods. Describe the basic procedures used during the study, including selection of study participants and observational and analytical methods. Define the primary outcomes that were measured for each group of subjects.
    • Results. Summarize the main findings, including specific effect sizes and their statistical significance, if possible. Include (if relevant) the number of participants in each group, the primary outcome for each group, and any significant adverse events or side effects.
    • Conclusion. In 1–2 sentences, state the principal conclusions, emphasizing new and important aspects of the study or observations.
    • Trial registration. List the public registry and trial registration number, e.g., ClinicalTrials.gov NCT00950003.
    • Funding. List all sources.

• Graphical abstract (optional)

  • Details are available here.

• Main text

  • Introduction
  • Results
  • Discussion
  • Methods
    • Statistics. Methods of statistical analysis summarized in a stand-alone paragraph located at the end of Methods right BEFORE “Study approval.”
    • Study approval. Declaration of approval of human and animal studies by the appropriate institutional review board(s) in a stand-alone paragraph titled “Study approval” at the end of Methods. For human studies, include a statement indicating that written informed consent was received prior to participation.

• Author contributions

  • Specify the contribution of each author (identified by initials) to the work.
  • Examples: designing research studies, conducting experiments, acquiring data, analyzing data, providing reagents, writing the manuscript
  • Multiple contributions may be listed for a single individual, and more than one author may be associated with a single contribution.
  • For manuscripts with 2 or more co–first authors, state the method used to assign the authorship order among these authors. For details, see the related JCI Editorial.

• Acknowledgments

  • State sources of support in the form of grants, equipment, or drugs.
  • Other appropriate acknowledgments (for example, of other scientists for help or advice) may also be included.

• References

  • See “How to prepare references for submission”

• Figures

  • See “How to prepare figures for submission”

• Tables

• Supplemental material

  • Supplemental material may include figures, tables, videos, or appendices but excludes large data sets.
  • Combine supplemental material (except videos and spreadsheets) into a single PDF file.
  • Before submission, carefully review all files; they will not be checked by a copy editor. JCI Insight is not responsible for any errors contained in data supplements.
  • In the case of accepted articles, the supplemental material will be posted online along with the final published article.