PLOS Medicine publishes original research articles of outstanding medical importance. We will consider manuscripts of any length; we encourage the submission of both substantial full-length bodies of work and shorter manuscripts that report novel findings that might be based on a more limited range of experiments.
The writing style should be concise and accessible, avoiding jargon so that the paper is understandable for readers outside a specialty or those whose first language is not English. Editors will make suggestions for how to achieve this, as well as suggestions for deletions or additions that could be made to the article to strengthen the argument. Our aim is to make the editorial process rigorous and consistent, but not intrusive or overbearing. Authors are encouraged to use their own voice and to decide how best to present their ideas, results, and conclusions.
PLOS Medicine is committed to the highest ethical standards in medical research. Accordingly, we ask authors to provide specific information regarding ethical treatment of research participants, patient consent, patient privacy, protocols, authorship, and competing interests. We also ask that reports of certain specific types of studies adhere to generally accepted standards. Our requirements are based on the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, issued by the International Committee for Medical Journal Editors.
Manuscript files should be submitted in DOC, DOCX, RTF, or PDF formats and should not be locked or protected.
LaTeX manuscripts must be submitted to Editorial Manager as PDFs. Read the LaTeX guidelines.
|Manuscripts can be any length. There are no restrictions on word count, number of figures, or amount of supporting information.
Use a standard font size and any standard font, except for Symbol font.
|Limit manuscript sections and sub-sections to 3 heading levels. Make sure heading levels are clearly indicated in the manuscript text.|
Manuscript text should be double-spaced.
Do not format text in multiple columns.
|Include page numbers and line numbers in the manuscript file.|
|Footnotes are not permitted. If your manuscript contains footnotes, move the information into the main text or the reference list, depending on the content.|
Manuscripts must be submitted in English.
You may submit translations of the manuscript or abstract as supporting information. Read the supporting information guidelines.
Define abbreviations upon first appearance in the text.
Do not use non-standard abbreviations unless they appear at least three times in the text. List all non-standard abbreviations (with definitions) in alphabetical order in a separate section at the beginning of the manuscript.
Keep abbreviations to a minimum.
PLOS uses “Vancouver” style, as outlined in the ICMJE sample references.
We recommend using MathType for display and inline equations, as it will provide the most reliable outcome. If this is not possible, Equation Editor is acceptable.
Avoid using MathType or Equation Editor to insert single variables (e.g., “a² + b² = c²”), Greek or other symbols (e.g., β, Δ, or ′ [prime]), or mathematical operators (e.g., x, ≥, or ±) in running text. Wherever possible, insert single symbols as normal text with the correct Unicode (hex) values.
Do not use MathType or Equation Editor for only a portion of an equation. Rather, ensure that the entire equation is included. Avoid “hybrid” inline or display equations, in which part is text and part is MathType, or part is MathType and part is Equation Editor.
Use correct and established nomenclature wherever possible.
Most manuscripts should be organized as follows. Instructions for each element appear below.
- Methods (or Methods and Materials)
- Supporting information captions
- Upon editorial acceptance, figure files should be uploaded separately from the manuscript, and each figure caption should be inserted in read order after the first paragraph where the figure is cited. Read more information about our figure requirements during each stage of editorial review.
- Tables are inserted immediately after the first paragraph in which they are cited.
- Supporting information files are uploaded separately.
Include a full title and a short title for the manuscript.
|Full title||200 characters||Specific, descriptive, concise, and comprehensible to readers outside the field||
Impact of Cigarette Smoke Exposure on Innate Immunity: A Caenorhabditis elegans ModelSolar Drinking Water Disinfection (SODIS) to Reduce Childhood Diarrhoea in Rural Bolivia: A Cluster-Randomized, Controlled Trial
|Short title||70 characters||State the topic of the study||
Cigarette Smoke Exposure and Innate ImmunitySODIS and Childhood Diarrhoea
Titles should be written in title case (all words capitalized except articles, prepositions, and conjunctions). Avoid specialist abbreviations if possible. For clinical trials, systematic reviews, or meta-analyses, the subtitle should include the study design.
All authors must meet the criteria for authorship as outlined in the authorship policy. Read the policy. Those who contributed to the work but do not meet the criteria for authorship can be mentioned in the Acknowledgments. Read more about Acknowledgments.
The corresponding author must provide an ORCID iD at the time of submission by entering it in the user profile in the submission system. Read more about ORCID.
Author names and affiliations
Enter author names on the title page of the manuscript and in the online submission system.
On the title page, write author names in the following order:
- First name (or initials, if used)
- Middle name (or initials, if used)
- Last name (surname, family name)
Each author on the list must have an affiliation. The affiliation includes department, university, or organizational affiliation and its location, including city, state/province (if applicable), and country.
If an author has multiple affiliations, enter all affiliations on the title page only. In the submission system, enter only the preferred or primary affiliation.
The submitting author is automatically designated as the corresponding author in the submission system. The corresponding author is the primary contact for the journal office and the only author able to view or change the manuscript while it is under editorial consideration.
The corresponding author role may be transferred to another coauthor. However, note that transferring the corresponding author role also transfers access to the manuscript. (To designate a new corresponding author while the manuscript is still under consideration, watch the video tutorial below.)
Only one corresponding author can be designated in the submission system, but this does not restrict the number of corresponding authors that may be listed on the article in the event of publication. Whoever is designated as a corresponding author on the title page of the manuscript file will be listed as such upon publication. Include an email address for each corresponding author listed on the title page of the manuscript.
How to select a new corresponding author in Editorial Manager
Consortia and group authorship
If a manuscript is submitted on behalf of a consortium or group, include the consortium or group name in the author list, and include the full list of members in the Acknowledgments or in a supporting information file. Read the group authorship policy.
Enter all author contributions in the submission system during submission. The contributions of all authors must be described using the CRediT Taxonomy of author roles. Read the policy.
To qualify for authorship, all contributors must meet at least one of the seven core contributions (conceptualization, methodology, software, validation, formal analysis, investigation, data curation), as well as at least one of the writing contributions (original draft preparation, review and editing). Authors may also satisfy the other remaining contributions; however, these alone will not qualify them for authorship.
Contributions will be published with the final article, and they should accurately reflect contributions to the work. The submitting author is responsible for completing this information at submission, and it is expected that all authors will have reviewed, discussed, and agreed to their individual contributions ahead of this time.
Upload a cover letter as a separate file in the online system.
The cover letter should address the following questions:
- Why is this manuscript suitable for publication in PLOS Medicine?
- Why will your study inspire researchers or clinicians, and how will it improve patient care or public health, or drive the understanding of disease forward?
The title, authors, and affiliations should all be included on a title page as the first page of the manuscript file.
The Abstract comes after the title page in the manuscript file. The abstract text is also entered in a separate field in the submission system.
The research article Abstract is divided into the following three sections: Background, Methods and Findings, and Conclusions. It should contain all the following elements (items in square brackets are needed only for some study types).
Please use the same format for abstracts submitted as presubmission inquiries. PLOS Medicine does not have a specific length requirement for abstracts submitted as part of the manuscript, but no more than 300 words can be submitted in the online interface of the manuscript submission system. If abstracts are longer than 300 words, please submit the first 300 words to the system.
This section should clearly describe the rationale for the study. It should end with a statement of the specific study hypothesis and/or study objectives.
Methods and Findings
- Describe the study participants or what was studied (e.g., patient population, cell lines; be as specific as possible, including numbers of individuals studied). Describe the study design, intervention if applicable, main methods used, primary outcome measure(s), and length of follow up if applicable.
- [If appropriate, include how many participants were assessed out of those enrolled. For survey research, include the response rate.]
- [If critical to the understanding of the paper, describe how results were analyzed, i.e., which specific statistical tests were used.]
- Describe the main outcomes and quantify the results using a measure of precision (e.g., 95% confidence interval). Describe any adverse events.
- Describe the main limitations of the study.
- Provide a general interpretation of the results with any important recommendations for future research.
- [For a clinical trial, provide any trial identification number(s) and name(s) (e.g., trial registration number, protocol number or acronym).]
The Introduction should put the focus of the manuscript into a broader context. As you compose the Introduction, think of readers who are not experts in this field. Include a brief review of the key literature. If there are relevant controversies or disagreements in the field, they should be mentioned so that a non-expert reader can delve into these issues further. The Introduction should conclude with a brief statement of the overall aim of the experiments and a comment about whether that aim was achieved.
The Methods should provide enough detail for reproduction of the research. Protocols for new methods should be included, but well-established methodological procedures may simply be referenced. A full description of the methods should be included in the manuscript itself rather than in a supplemental file.
Methods should also include a section with descriptions of any statistical methods used. The description should conform to the criteria outlined by the Uniform Requirements, as follows:
The Results section should include all primary and secondary outcome measures analyzed. The section may be divided into subsections, each with a concise subheading. Tables and figures central to the study should be included in the main paper. The Results section should be written in past tense.
PLOS journals require authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception.
Large data sets, including raw data, may be deposited in an appropriate public repository. See our list of recommended repositories.
For smaller data sets and certain data types, authors may provide their data within Supporting Information files accompanying the manuscript. Authors should take care to maximize the accessibility and reusability of the data by selecting a file format from which data can be efficiently extracted (for example, spreadsheets or flat files should be provided rather than PDFs when providing tabulated data).
For more information on how best to provide data, read our policy on data availability. PLOS does not accept references to “data not shown.”
As outlined in the Uniform Requirements:
The Discussion should be concise and tightly argued. It should start with a brief summary of the main findings. It should include paragraphs on the generalizability, clinical relevance, strengths, and limitations of your study.
You may wish to discuss the following points also:
- How do the conclusions affect the existing knowledge in the field?
- How can future research build on these observations and what are the key experiments that must be done?
Those who contributed to the work but do not meet our authorship criteria should be listed in the Acknowledgments with a description of the contribution.
Authors are responsible for ensuring that anyone named in the Acknowledgments agrees to be named.
Any and all available works can be cited in the reference list. Acceptable sources include:
- Published or accepted manuscripts
- Manuscripts on preprint servers, if the manuscript is submitted to a journal and also publicly available as a preprint
Do not cite the following sources in the reference list:
- Unavailable and unpublished work, including manuscripts that have been submitted but not yet accepted (e.g., “unpublished work,” “data not shown”). Instead, include those data as supplementary material or deposit the data in a publicly available database.
- Personal communications (these should be supported by a letter from the relevant authors but not included in the reference list)
References are listed at the end of the manuscript and numbered in the order that they appear in the text. In the text, cite the reference number in square brackets (e.g., “We used the techniques developed by our colleagues  to analyze the data”). PLOS uses the numbered citation (citation-sequence) method and first six authors, et al.
Do not include citations in abstracts or author summaries.
Make sure the parts of the manuscript are in the correct order before ordering the citations.
PLOS uses the reference style outlined by the International Committee of Medical Journal Editors (ICMJE), also referred to as the “Vancouver” style. Example formats are listed below. Additional examples are in the ICMJE sample references.
Journal name abbreviations should be those found in the National Center for Biotechnology Information (NCBI) databases.
Hou WR, Hou YL, Wu GF, Song Y, Su XL, Sun B, et al. cDNA, genomic sequence cloning and overexpression of ribosomal protein gene L9 (rpL9) of the giant panda (Ailuropoda melanoleuca). Genet Mol Res. 2011;10: 1576-1588.
Devaraju P, Gulati R, Antony PT, Mithun CB, Negi VS. Susceptibility to SLE in South Indian Tamils may be influenced by genetic selection pressure on TLR2 and TLR9 genes. Mol Immunol. 2014 Nov 22. pii: S0161-5890(14)00313-7. doi: 10.1016/j.molimm.2014.11.005
Note: A DOI number for the full-text article is acceptable as an alternative to or in addition to traditional volume and page numbers.
|Accepted, unpublished articles||Same as published articles, but substitute “Forthcoming” for page numbers or DOI.|
|Web sites or online articles||
Huynen MMTE, Martens P, Hilderlink HBM. The health impacts of globalisation: a conceptual framework. Global Health. 2005;1: 14. Available from: http://www.globalizationandhealth.com/content/1/1/14.
Bates B. Bargaining for life: A social history of tuberculosis. 1st ed. Philadelphia: University of Pennsylvania Press; 1992.
|Book chapters||Hansen B. New York City epidemics and history for the public. In: Harden VA, Risse GB, editors. AIDS and the historian. Bethesda: National Institutes of Health; 1991. pp. 21-28.|
|Deposited articles (preprints, e-prints, or arXiv)||Krick T, Shub DA, Verstraete N, Ferreiro DU, Alonso LG, Shub M, et al. Amino acid metabolism conflicts with protein diversity; 1991. Preprint. Available from: arXiv:1403.3301v1. Cited 17 March 2014.|
|Published media (print or online newspapers and magazine articles)||Fountain H. For Already Vulnerable Penguins, Study Finds Climate Change Is Another Danger. The New York Times. 29 Jan 2014. Available from: http://www.nytimes.com/2014/01/30/science/earth/climate-change-taking-toll-on-penguins-study-finds.html. Cited 17 March 2014.|
|New media (blogs, web sites, or other written works)||Allen L. Announcing PLOS Blogs. 2010 Sep 1 [cited 17 March 2014]. In: PLOS Blogs [Internet]. San Francisco: PLOS 2006 - . [about 2 screens]. Available from: http://blogs.plos.org/plos/2010/09/announcing-plos-blogs/.|
|Masters' theses or doctoral dissertations||Wells A. Exploring the development of the independent, electronic, scholarly journal. M.Sc. Thesis, The University of Sheffield. 1999. Available from: http://cumincad.scix.net/cgi-bin/works/Show?2e09|
|Databases and repositories (Figshare, arXiv)||Roberts SB. QPX Genome Browser Feature Tracks; 2013 [cited 2013 Oct 5]. Database: figshare [Internet]. Available from: http://figshare.com/articles/QPX_Genome_Browser_Feature_Tracks/701214.|
|Multimedia (videos, movies, or TV shows)||Hitchcock A, producer and director. Rear Window [Film]; 1954. Los Angeles: MGM.|
Authors can submit essential supporting files and multimedia files along with their manuscripts. All supporting information will be subject to peer review. All file types can be submitted, but files must be smaller than 10 MB in size.
Authors may use almost any description as the item name for a supporting information file as long as it contains an “S” and number. For example, “S1 Appendix” and “S2 Appendix,” “S1 Table” and “S2 Table,” and so forth.
Supporting information files are published exactly as provided, and are not copyedited.
Supporting information captions
List supporting information captions at the end of the manuscript file. Do not submit captions in a separate file.
The file number and name are required in a caption, and we highly recommend including a one-line title as well. You may also include a legend in your caption, but it is not required.
S1 Text. Title is strongly recommended. Legend is optional.
We recommend that you cite supporting information in the manuscript text, but this is not a requirement. If you cite supporting information in the text, citations do not need to be in numerical order.
If you are submitting a new manuscript, embed each figure in the manuscript in read order, immediately following the paragraph where the figure is first mentioned and above the related figure caption.
Upon revision, each figure must be prepared and submitted to the submission system as an individual file. Additionally, embed the same figures in the manuscript in read order, and ensure that they match the figure files that you uploaded.
Upon acceptance, figure files should be uploaded to the submission system, with no embedded figures in the manuscript.
Cite figures in ascending numeric order upon first appearance in the manuscript file.
Figure captions must be inserted in the text of the manuscript, immediately following the paragraph in which the figure is first cited (read order). Do not include captions as part of the figure files themselves or submit them in a separate document.
At a minimum, include the following in your figure captions:
- A figure label with Arabic numerals, and “Figure” abbreviated to “Fig” (e.g. Fig 1, Fig 2, Fig 3, etc). Match the label of your figure with the name of the file uploaded at submission (e.g. a figure citation of “Fig 1” must refer to a figure file named “Fig1.tif”).
- A concise, descriptive title
The caption may also include a legend as needed.
As part of our efforts to improve published figure quality, we routinely and thoroughly check all main and supporting figures for all papers editorially accepted for publication in PLOS Medicine. In doing so, we not only ensure that all figure files meet our requirements for publication and are available to publish under our CC BY license, but also that we remain vigilant to image manipulation of photographic images.
Image files should not be manipulated or adjusted in any way that could lead to misinterpretation of the information present in the original image. For full details on best practices regarding your figures, read our figure guidelines.
If evidence is found of inappropriate manipulation, we reserve the right to ask for original data and, if that is not satisfactory, we may decide not to accept the manuscript, and may also contact the authors' institutions to ask them to assist with investigation.
In checking for manipulation, we may request higher resolution versions of your images, or the original images, so that we can efficiently and accurately check all figures.
If you ever need to email files to the journal office, our system has a 10 MB attachment limit, meaning that we will not receive any emails larger than this size. If your files are larger than 10 MB, please either send them one email at a time, or look into reducing the size of the files. If you are having problems sending us large files, please contact the journal office for details of how we can help you transfer your files.
Cite tables in ascending numeric order upon first appearance in the manuscript file.
Place each table in your manuscript file directly after the paragraph in which it is first cited (read order). Do not submit your tables in separate files.
Tables require a label (e.g., “Table 1”) and brief descriptive title to be placed above the table. Place legends, footnotes, and other text below the table.
All data and related metadata underlying the findings reported in a submitted manuscript should be deposited in an appropriate public repository, unless already provided as part of the submitted article.
Repositories may be either subject-specific (where these exist) and accept specific types of structured data, or generalist repositories that accept multiple data types. We recommend that authors select repositories appropriate to their field. Repositories may be subject-specific (e.g., GenBank for sequences and PDB for structures), general, or institutional, as long as DOIs or accession numbers are provided and the data are at least as open as CC BY. Authors are encouraged to select repositories that meet accepted criteria as trustworthy digital repositories, such as criteria of the Centre for Research Libraries or Data Seal of Approval. Large, international databases are more likely to persist than small, local ones.
To support data sharing and author compliance of the PLOS data policy, we have integrated our submission process with a select set of data repositories. The list is neither representative nor exhaustive of the suitable repositories available to authors. Current repository integration partners include Dryad and FlowRepository. Please contact firstname.lastname@example.org to make recommendations for further partnerships.
Instructions for PLOS submissions with data deposited in an integration partner repository:
- Deposit data in the integrated repository of choice.
- Once deposition is final and complete, the repository will provide you with a dataset DOI (provisional) and private URL for reviewers to gain access to the data.
- Enter the given data DOI into the full Data Availability Statement, which is requested in the Additional Information section of the PLOS submission form. Then provide the URL passcode in the Attach Files section.
If you have any questions, please email us.
All appropriate data sets, images, and information should be deposited in an appropriate public repository. See our list of recommended repositories.
Accession numbers (and version numbers, if appropriate) should be provided in the Data Availability Statement. Accession numbers or a citation to the DOI should also be provided when the data set is mentioned within the manuscript.
In some cases authors may not be able to obtain accession numbers of DOIs until the manuscript is accepted; in these cases, the authors must provide these numbers at acceptance. In all other cases, these numbers must be provided at submission.
As much as possible, please provide accession numbers or identifiers for all entities such as genes, proteins, mutants, diseases, etc., for which there is an entry in a public database, for example:
- Entrez Gene
- Mouse Genome Database (MGD)
- Online Mendelian Inheritance in Man (OMIM)
Identifiers should be provided in parentheses after the entity on first use.
This section should describe sources of funding that have supported the work. Please include relevant grant numbers and the URL of any funder's web site. Please also include this sentence: “The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.” If this statement is not correct, you must describe the role of any sponsors or funders, and amend the aforementioned sentence as needed.
This section should list specific competing interests associated with any of the authors. If authors declare that no competing interests exist, the article will include a statement to this effect.
All authors will be contacted by email at submission of the full paper to declare whether they have any financial, personal or professional interests that could be construed to have influenced their paper. Any relevant competing interests of authors must be available to editors and reviewers during the review process and will be stated in published articles.
When submitting a manuscript, all authors are asked to indicate that they do not have a related or duplicate manuscript under consideration (or accepted) for publication elsewhere. If related work has been or will be submitted elsewhere or is in press elsewhere, then a copy must be uploaded with the article submitted to PLOS. Reviewers will be asked to comment on the overlap between related submissions.
PLOS does support authors who wish to share their work early and receive feedback before formal peer review. Deposition of manuscripts with preprint servers does not impact consideration of the manuscript at any PLOS journal.
Authors choosing bioRxiv may now concurrently submit directly to select PLOS journals through bioRxiv’s direct transfer to journal service.
Authors must check the EQUATOR Network site for any reporting guidelines that apply to the particular study design and ensure they include any required supporting information recommended by the relevant guidelines.
All research involving humans and animals must have been approved by the authors' institutional review board or equivalent committee(s), and that board must be named by the authors in the manuscript.
For research involving human participants, informed consent must have been obtained or the reason for lack of consent explained, and all clinical investigations must have been conducted according to the principles expressed in the Declaration of Helsinki. The Methods section of the paper must state whether informed consent was written or oral. If informed consent was oral, it must be stated in the paper: (a) why written consent could not be obtained, (b) that the IRB approved the use of oral consent, and (c) how oral consent was documented.
Authors may be required to submit, on request, a statement from the research ethics committee or institutional review board indicating approval of the research. We also encourage authors to submit a sample of a patient consent form, and may require submission in particular instances.
For studies involving humans categorized by race/ethnicity, age, disease/disabilities, religion, sex/gender, sexual orientation, or other socially constructed groupings, authors should, as much as possible,
- make explicit their methods of categorizing human populations;
- define categories in as much detail as the study protocol allows;
- justify their choices of definitions and categories, including for example whether any rules of human categorization were required by their funding agency;
- explain whether (and if so, how) they controlled for confounding variables such as socioeconomic status, nutrition, environmental exposures, etc.
In addition, outmoded terms and potentially stigmatizing labels should be changed to more current, acceptable terminology. For example, “white” should be used rather than “Caucasian” and “patients with cancer” should be used rather than “cancer patients” or “cancer victims”.
PLOS Medicine publishes few animal studies but will consider animal studies of two kinds:
- Translational studies that establish a novel explanatory mechanism for a significant clinical problem, to an extent that will directly inform specific clinical approaches. Such papers must include or refer to human data that is sufficiently compelling to establish clinical relevance of the animal model.
- Models relevant to the treatment or prevention of major health problems, in which the interventions cannot be tested in humans for ethical reasons, but will provide compelling justification for specific changes in the design of subsequent clinical trials.
All animal work must have been conducted according to relevant national and international guidelines. In addition, PLOS Medicine requires that animal research follows the ARRIVE guidelines. In accordance with the recommendations of the Weatherall report, The use of non-human primates in research (PDF), we specifically require authors to include details of animal welfare and steps taken to ameliorate suffering in all work involving non-human primates. The institution that approved the study must be named, and it must be stated in the paper that the study was conducted adhering to the institution's guidelines for animal husbandry.
Our human participant policy conforms to the Uniform Requirements of the International Committee of Medical Journal Editors:
Patients have a right to privacy that should not be infringed without informed consent. Identifying information should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that the patient be shown the manuscript to be published. Complete anonymity is difficult to achieve, and informed consent for publication should be obtained if there is any doubt. If data are changed to protect anonymity, authors should provide assurance that alterations of the data do not distort scientific meaning. When informed consent has been obtained it should be indicated in the published article.
For papers that include identifying information, or potentially identifying information, authors must download the Consent Form for Publication in a PLOS Journal from our web site, which the patient, parent, or guardian must sign once they have read the paper and been informed about the terms of the PLOS content license.
Once authors have obtained the signed consent form, it should be filed securely in the patient's case notes and the manuscript submitted to PLOS should include this statement indicating that specific consent for publication was obtained: “The patients in this manuscript have given written informed consent (as outlined in the PLOS consent form) to publication of their case details.”
Download the PLOS consent form:
PLOS follows the World Health Organization’s (WHO) definition of a clinical trial:
Registering Clinical Trials
All clinical trials submitted to PLOS journals must be entered in a publicly accessible registry approved by the WHO or ICMJE. See the list of approved registries.
PLOS journals consider prospective trial registration (that is, registration before participant enrollment has begun) to be best publication practice, as recommended by the ICMJE. Clinical trials that began to enroll participants before ICMJE recommendations took effect on July 1, 2005 may be retrospectively registered.
More information about trial registration, including the WHO definition of a clinical trial, is in the ICMJE FAQ.
PLOS Medicine is unlikely to publish clinical trials that are not prospectively registered. We recognize, however, that in rare cases late registration may occur for exceptional reasons that merit consideration. Authors seeking evaluation by PLOS Medicine of a non–prospectively registered clinical trial must provide a compelling reason for lack of prospective registration.
In addition, as for all PLOS journals, authors wishing to submit a clinical trial that was not publicly registered before participant enrollment began must register the trial retrospectively in a publicly accessible registry. They must also:
- Register all related clinical trials and confirm they have done so in the Methods section
- Explain in the Methods the specific reasons for failing to register before participant enrollment
- Confirm that future trials will be registered prospectively
PLOS journal editors may decline to further consider any clinical trial for which, in the editor’s judgment, absence of prospective registration raises concerns of selective publication or selective reporting of research outcomes.
PLOS supports the public disclosure of all clinical trial results, as mandated, for example, by the 2007 FDA Amendments Act. Prior disclosure of results on a clinical trial registry site will not affect consideration.
Clinical trial reports must adhere to the relevant reporting guidelines for their study design, such as CONSORT for randomized controlled trials, TREND for non-randomized trials, and other specialized guidelines as appropriate.
For all clinical trial submissions, authors must include the following:
- Registration details (reported in the Methods section and in the submission form)
- CONSORT checklist or relevant reporting guideline (uploaded as supporting information)
- CONSORT flow diagram (uploaded as Fig 1)
- Trial protocol (uploaded as supporting information)
- Details of prior approval for human subjects research by an institutional review board (IRB) or equivalent ethics committee(s)
The submission will not be considered if documentation is not provided. The checklist, flow diagram, and protocol will be published with the article if the manuscript is accepted.
The manuscript file must include the following information:
- An explanation of any deviation from the trial protocol
- Description of informed consent obtained from participants
- Any information on statistical methods or participants not indicated in the CONSORT documentation
Reports of systematic reviews and meta-analyses must adhere to the PRISMA Statement or alternative guidelines appropriate to the study design, and include the completed checklist and flow diagram to accompany the main text. Authors must complete the appropriate reporting checklist not only with page references, but also with sufficient text excerpted from the manuscript to explain how they accomplished all applicable items.
Abstracts should follow PRISMA for Abstracts, using the PLOS abstract format. Authors must also state within the Methods section of their paper whether a protocol exists for their systematic review, and if so, provide a copy of the protocol as supporting information.
The journal supports the prospective registration of systematic reviews. Authors whose systematic review was prospectively registered (e.g., in a registry such as PROSPERO) should provide the registry number in their abstract. Registry details and protocols will be made available to editors and reviewers, and included with the paper if the report is ultimately published.
PLOS Medicine does not publish narrative reviews except as part of invited Collections
Reports of studies of diagnostic accuracy must adhere to the STARD requirements or alternative guidelines appropriate to the study design (see the EQUATOR web site) and include a completed checklist as supporting information. Authors must complete the appropriate reporting checklist not only with page references, but also with sufficient text excerpted from the manuscript to explain how they addressed all applicable items.
For observational studies, including case control, cohort, and cross-sectional studies, authors must adhere to the STROBE Statement or alternative guidelines appropriate to the study design (see the EQUATOR web site) and include a completed checklist as supporting information. Authors must complete the appropriate reporting checklist not only with page references, but also with sufficient text excerpted from the manuscript to explain how they addressed all applicable items.
For observational studies, authors are required to clearly specify (a) What specific hypotheses the researchers intended to test, and the analytical methods by which they planned to test them; (b) What analyses they actually performed; and (c) When reported analyses differ from those that were planned, authors must provide transparent explanations for differences that affect the reliability of the study's results.
If a prospective analysis plan (from the study's funding proposal, IRB or other ethics committee submission, study protocol, or other planning document written before analyzing the data) was used in designing an observational study, authors must include the relevant prospectively written document with the manuscript submission for access by editors and reviewers and eventual publication alongside the accepted paper. If no prospectively written document exists, authors should explain how and when they determined the analyses being reported.
Reports of microarray experiments must conform to the MIAME guidelines, and the data from the experiments must be deposited in a publicly accessible database.
We recommend authors refer to the BioSharing Portal for prescriptive checklists for reporting biological and biomedical research where applicable.
Studies including animals must follow the ARRIVE guidelines and include a completed ARRIVE checklist as supporting information. Authors must complete the appropriate reporting checklist not only with page references, but also with sufficient text excerpted from the manuscript to explain how they addressed all applicable items.
If you are submitting content other than a research article, read the guidelines for other article types.