Preparing for Submission
1. General Principles
The text of articles reporting original research is usually divided into Introduction, Methods, Results, and Discussion sections. This so-called “IMRAD” structure is not an arbitrary publication format but a reflection of the process of scientific discovery. Articles often need subheadings within these sections to further organize their content. Other types of articles, such as meta-analyses, may require different formats, while case reports, narrative reviews, and editorials may have less structured or unstructured formats.
Electronic formats have created opportunities for adding details or sections, layering information, cross-linking, or extracting portions of articles in electronic versions. Supplementary electronic-only material should be submitted and sent for peer review simultaneously with the primary manuscript.
2. Reporting Guidelines
Reporting guidelines have been developed for different study designs; examples include CONSORT for randomized trials, STROBE for observational studies, PRISMA for systematic reviews and meta-analyses, and STARD for studies of diagnostic accuracy. Journals are encouraged to ask authors to follow these guidelines because they help authors describe the study in enough detail for it to be evaluated by editors, reviewers, readers, and other researchers evaluating the medical literature. Authors of review manuscripts are encouraged to describe the methods used for locating, select¬ing, extracting, and synthesizing data; this is mandatory for systematic reviews. Good sources for reporting guidelines are the EQUATOR Network and the NLM's Research Reporting Guidelines and Initiatives.
3. Manuscript Sections
The following are general requirements for reporting within sections of all study designs and manuscript formats.
a. Title Page
General information about an article and its authors is presented on a manuscript title page and usually includes the article title, author information, any disclaimers, sources of support, word count, and sometimes the number of tables and figures.Article title. The title provides a distilled description of the complete article and should include information that, along with the Abstract, will make electronic retrieval of the article sensitive and specific. Reporting guidelines recommend and some journals require that information about the study design be a part of the title (particularly important for randomized trials and systematic reviews and meta-analyses). Some journals require a short title, usually no more than 40 characters (including letters and spaces) on the title page or as a separate entry in an electronic submission system. Electronic submission systems may restrict the number of characters in the title. Author information: Each author's highest academic degrees should be listed, although some journals do not publish these. The name of the department(s) and institution(s) or organizations where the work should be attributed should be specified. Most electronic submission systems require that authors provide full contact information, including land mail and e-mail addresses, but the title page should list the corresponding authors' telephone and fax numbers and e-mail address. ICMJE encourages the listing of authors’ Open Researcher and Contributor Identification (ORCID). Disclaimers. An example of a disclaimer is an author's statement that the views expressed in the submitted article are his or her own and not an official position of the institution or funder. Source(s) of support. These include grants, equipment, drugs, and/or other support that facilitated conduct of the work described in the article or the writing of the article itself. Word count. A word count for the paper's text, excluding its abstract, acknowledgments, tables, figure legends, and references, allows editors and reviewers to assess whether the information contained in the paper warrants the paper's length, and whether the submitted manuscript fits within the journal's formats and word limits. A separate word count for the Abstract is useful for the same reason. Number of figures and tables. Some submission systems require specification of the number of Figures and Tables before uploading the relevant files. These numbers allow editorial staff and reviewers to confirm that all figures and tables were actually included with the manuscript and, because Tables and Figures occupy space, to assess if the information provided by the figures and tables warrants the paper's length and if the manuscript fits within the journal's space limits. Conflict of Interest declaration. Conflict of interest information for each author needs to be part of the manuscript; each journal should develop standards with regard to the form the information should take and where it will be posted. The ICMJE has developed a uniform conflict of interest disclosure form for use by ICMJE member journals and the ICMJE encourages other journals to adopt it. Despite availability of the form, editors may require conflict of interest declarations on the manuscript title page to save the work of collecting forms from each author prior to making an editorial decision or to save reviewers and readers the work of reading each author's form.
Original research, systematic reviews, and meta-analyses require structured abstracts. The abstract should provide the context or background for the study and should state the study's purpose, basic procedures (selection of study participants, settings, measurements, analytical methods), main findings (giving specific effect sizes and their statistical and clinical significance, if possible), and principal conclusions. It should emphasize new and important aspects of the study or observations, note important limitations, and not overinterpret findings. Clinical trial abstracts should include items that the CONSORT group has identified as essential. Funding sources should be listed separately after the Abstract to facilitate proper display and indexing for search retrieval by MEDLINE.
Because abstracts are the only substantive portion of the article indexed in many electronic databases, and the only portion many readers read, authors need to ensure that they accurately reflect the content of the article. Unfortunately, information in abstracts often differs from that in the text. Authors and editors should work in the process of revision and review to ensure that information is consistent in both places. The format required for structured abstracts differs from journal to journal, and some journals use more than one format; authors need to prepare their abstracts in the format specified by the journal they have chosen.
The ICMJE recommends that journals publish the clinical trial registration number at the end of the abstract. The ICMJE also recommends that, when a registration number is available, authors list that number the first time they use a trial acronym to refer to the trial they are reporting or to other trials that they mention in the manuscript. If the data have been deposited in a public repository, authors should state at the end of the abstract the data set name, repository name and number.
Provide a context or background for the study (that is, the nature of the problem and its significance). State the specific purpose or research objective of, or hypothesis tested by, the study or observation. Cite only directly pertinent references, and do not include data or conclusions from the work being reported.
The guiding principle of the Methods section should be clarity about how and why a study was done in a particular way. Methods section should aim to be sufficiently detailed such that others with access to the data would be able to reproduce the results. In general, the section should include only information that was available at the time the plan or protocol for the study was being written; all information obtained during the study belongs in the Results section. If an organization was paid or otherwise contracted to help conduct the research (examples include data collection and management), then this should be detailed in the methods.
The Methods section should include a statement indicating that the research was approved or exempted from the need for review by the responsible review committee (institutional or national). If no formal ethics committee is available, a statement indicating that the research was conducted according to the principles of the Declaration of Helsinki should be included.
i. Selection and Description of Participants
Clearly describe the selection of observational or experimental participants (healthy individuals or patients, including controls), including eligibility and exclusion criteria and a description of the source population. Because the relevance of such variables as age, sex, or ethnicity is not always known at the time of study design, researchers should aim for inclusion of representative populations into all study types and at a minimum provide descriptive data for these and other relevant demographic variables. Ensure correct use of the terms sex (when reporting biological factors) and gender (identity, psychosocial or cultural factors), and, unless inappropriate, report the sex and/or gender of study participants, the sex of animals or cells, and describe the methods used to determine sex and gender. If the study was done involving an exclusive population, for example in only one sex, authors should justify why, except in obvious cases, (e.g., prostate cancer).” Authors should define how they determined race or ethnicity and justify their relevance.
ii. Technical Information
Specify the study's main and secondary objectives–usually identified as primary and secondary outcomes. Identify methods, equipment (give the manufacturer's name and address in parentheses), and procedures in sufficient detail to allow others to reproduce the results. Give references to established methods, including statistical methods (see below); provide references and brief descrip¬tions for methods that have been published but are not well-known; describe new or substantially modified methods, give the reasons for using them, and evaluate their limitations. Identify precisely all drugs and chemicals used, including generic name(s), dose(s), and route(s) of administration. Identify appropriate scientific names and gene names.
Describe statistical methods with enough detail to enable a knowledgeable reader with access to the original data to judge its appropriateness for the study and to verify the reported results. When possible, quantify findings and present them with appropriate indicators of mea¬surement error or uncertainty (such as confidence intervals). Avoid relying solely on statistical hypothesis testing, such as P values, which fail to convey important information about effect size and precision of estimates. References for the design of the study and statistical methods should be to standard works when possible (with pages stated). Define statistical terms, abbreviations, and most symbols. Specify the statistical software package(s) and versions used. Distinguish prespecified from exploratory analyses, including subgroup analyses.
Present your results in logical sequence in the text, tables, and figures, giving the main or most important findings first. Do not repeat all the data in the tables or figures in the text; emphasize or summarize only the most important observations. Provide data on all primary and secondary outcomes identified in the Methods Section. Extra or supplementary materials and technical details can be placed in an appendix where they will be accessible but will not interrupt the flow of the text, or they can be published solely in the electronic version of the journal.
Give numeric results not only as derivatives (for example, percentages) but also as the absolute numbers from which the derivatives were calculated, and specify the statistical significance attached to them, if any. Restrict tables and figures to those needed to explain the argument of the paper and to assess supporting data. Use graphs as an alternative to ta¬bles with many entries; do not duplicate data in graphs and tables. Avoid nontechnical uses of technical terms in statistics, such as “random” (which implies a randomizing device), “normal,” “significant,” “correlations,” and “sample.”
Separate reporting of data by demographic variables, such as age and sex, facilitate pooling of data for subgroups across studies and should be routine, unless there are compelling reasons not to stratify reporting, which should be explained.
It is useful to begin the discussion by brieﬂy summarizing the main ﬁndings, and explore possible mechanisms or explanations for these ﬁndings. Emphasize the new and important aspects of your study and put your finings in the context of the totality of the relevant evidence. State the limitations of your study, and explore the implications of your ﬁndings for future research and for clinical practice or policy. Discuss the influence or association of variables, such as sex and/or gender, on your findings, where appropriate, and the limitations of the data. Do not repeat in detail data or other information given in other parts of the manuscript, such as in the Introduction or the Results section.
Link the conclusions with the goals of the study but avoid unqualified statements and conclusions not adequately supported by the data. In particular, distinguish between clinical and statistical significance, and avoid making statements on economic benefits and costs unless the manuscript includes the appropriate economic data and analyses. Avoid claiming priority or alluding to work that has not been completed. State new hypotheses when war¬ranted, but label them clearly.
i. General Considerations Related to References
Authors should provide direct references to original research sources whenever possible. References should not be used by authors, editors, or peer reviewers to promote self-interests. Although references to review articles can be an efficient way to guide readers to a body of literature, review articles do not always reflect original work accurately. On the other hand, extensive lists of references to original work on a topic can use excessive space. Fewer references to key original papers often serve as well as more exhaustive lists, particularly since references can now be added to the electronic version of published papers, and since electronic literature searching allows readers to retrieve published literature efficiently.
Do not use conference abstracts as references: they can be cited in the text, in parentheses, but not as page footnotes. References to papers accepted but not yet published should be designated as “in press” or “forthcoming.” Information from manuscripts submitted but not accepted should be cited in the text as “unpublished observations” with written permission from the source.
Avoid citing a “personal communication” unless it provides essential information not available from a public source, in which case the name of the person and date of communication should be cited in parentheses in the text. For scientific articles, obtain written permission and confirmation of accuracy from the source of a personal communication.
Some but not all journals check the accuracy of all reference citations; thus, citation errors sometimes appear in the published version of articles. To minimize such errors, references should be verified using either an electronic bibliographic source, such as PubMed, or print copies from original sources. Authors are responsible for checking that none of the references cite retracted articles except in the context of referring to the retraction. For articles published in journals indexed in MEDLINE, the ICMJE considers PubMed the authoritative source for information about retractions. Authors can identify retracted articles in MEDLINE by searching PubMed for "Retracted pub¬lication [pt]", where the term "pt" in square brackets stands for publication type, or by going directly to the PubMed's list of retracted publications.
References should be numbered consecutively in the order in which they are first mentioned in the text. Identify references in text, tables, and legends by Arabic numerals in parentheses.
References cited only in tables or figure legends should be numbered in accordance with the sequence established by the first identification in the text of the particular table or figure. The titles of journals should be abbreviated according to the style used for MEDLINE (www.ncbi.nlm.nih.gov/nlmcatalog/journals). Journals vary on whether they ask authors to cite electronic references within parentheses in the text or in numbered references following the text. Authors should consult with the journal to which they plan to submit their work.
ii. Reference Style and Format
References should follow the standards summarized in the NLM's International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals: Sample References webpage and detailed in the NLM's Citing Medicine, 2nd edition. These resources are regularly updated as new media develop, and currently include guidance for print documents; unpublished material; audio and visual media; material on CD-ROM, DVD, or disk; and material on the Internet.
Tables capture information concisely and display it efficiently; they also provide information at any desired level of detail and precision. Including data in tables rather than text frequently makes it possible to reduce the length of the text.
Prepare tables according to the specific journal's requirements; to avoid errors it is best if tables can be directly imported into the journal's publication software. Number tables consecutively in the order of their first citation in the text and supply a title for each. Titles in tables should be short but self-explanatory, containing information that allows readers to understand the table's content without having to go back to the text. Be sure that each table is cited in the text.
Give each column a short or an abbreviated heading. Authors should place explanatory matter in footnotes, not in the heading. Explain all nonstandard abbreviations in footnotes, and use symbols to explain information if needed. Symbols may vary from journal to journal (alphabet letter or such symbols as *, †, ‡, §), so check each journal's instructions for authors for required practice. Identify statistical measures of variations, such as standard deviation and standard error of the mean.
If you use data from another published or unpublished source, obtain permission and acknowledge that source fully.
Additional tables containing backup data too extensive to publish in print may be appropriate for publication in the electronic version of the journal, deposited with an archival service, or made available to readers directly by the authors. An appropriate statement should be added to the text to inform readers that this additional information is available and where it is located. Submit such tables for consideration with the paper so that they will be available to the peer reviewers.
i. Illustrations (Figures)
Digital images of manuscript illustrations should be submitted in a suitable format for print publication. Most submission systems have detailed instructions on the quality of images and check them after manuscript upload. For print submissions, figures should be either professionally drawn and photographed, or submitted as photographic-quality digital prints.
For radiological and other clinical and diagnostic images, as well as pictures of pathology specimens or photomicrographs, send high-resolution photographic image files. Before-and-after images should be taken with the same intensity, direction, and color of light. Since blots are used as primary evidence in many scientific articles, editors may require deposition of the original photographs of blots on the journal's website.
Although some journals redraw figures, many do not. Letters, numbers, and symbols on figures should therefore be clear and consistent throughout, and large enough to remain legible when the figure is reduced for publication. Figures should be made as self-explanatory as possible, since many will be used directly in slide presentations. Titles and detailed explanations belong in the legends—not on the illustrations themselves.
Photomicrographs should have internal scale markers. Symbols, arrows, or letters used in photomicrographs should contrast with the background. Explain the internal scale and identify the method of staining in photomicrographs.
Figures should be numbered consecutively according to the order in which they have been cited in the text. If a figure has been published previously, acknowledge the original source and submit written permission from the copyright holder to reproduce it. Permission is required irrespective of authorship or publisher except for documents in the public domain.
In the manuscript, legends for illustrations should be on a separate page, with Arabic numerals corresponding to the illustrations. When symbols, arrows, numbers, or letters are used to identify parts of the illustrations, identify and explain each one clearly in the legend.
j. Units of Measurement
Measurements of length, height, weight, and volume should be reported in metric units (meter, kilogram, or liter) or their decimal multiples.
Temperatures should be in degrees Celsius. Blood pressures should be in millimeters of mercury, unless other units are specifically required by the journal.
Journals vary in the units they use for reporting hematologic, clinical chemistry, and other measurements. Authors must consult the Information for Authors of the particular journal and should report laboratory information in both local and International System of Units (SI).
Editors may request that authors add alternative or non-SI units, since SI units are not universally used. Drug concentrations may be reported in either SI or mass units, but the alternative should be provided in parentheses where appropriate.
k. Abbreviations and Symbols
Use only standard abbreviations; use of nonstandard abbreviations can be confusing to readers. Avoid abbreviations in the title of the manuscript. The spelled-out abbreviation followed by the abbreviation in parenthesis should be used on first mention unless the abbreviation is a standard unit of measurement.
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