ÌÇÐÄvlog

Instructions for Authors

Contact Information

How Do I?

Determine My Article Type

Categories of Articles

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How Do I?

Format My Manuscript

Manuscript Preparation and Submission Requirements

Manuscript Submission

All manuscripts must be submitted online via the .

At the time of submission, complete contact information (affiliation, postal/mail address, email address, and telephone numbers) for the corresponding author is required. First and last names, email addresses, and institutional affiliations of all coauthors are also required. After the manuscript is submitted, the corresponding author will receive an acknowledgment confirming receipt and a manuscript number. Authors will be able to track the status of their manuscripts via the online system. After manuscript submission, all authors of papers under consideration for publication will be sent a link to the Authorship Form to complete and submit. See other details in these instructions for additional requirements.^2,4

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Copies of Previous Editorial and Reviewer Comments

As recommended by the ICMJE, "if the manuscript has been submitted previously to another journal, it is helpful to include the previous editors' and reviewers' comments with the submitted manuscript, along with the authors' responses to those comments."⁴ It is not uncommon for manuscripts to have been submitted to and peer reviewed by other journals and sharing this information will not bias an editor's decision for this journal. Thus, authors are encouraged to submit these previous comments in their entirety and indicate how they have revised the manuscript in response to these comments, which may expedite the review process. In the submission system, there is a file type for Previous Peer Review and Editorial Comments.

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Cover Letter

Include a cover letter and complete contact information for the corresponding author (affiliation, postal/mail address, email address, and telephone number) and whether the authors have published, posted, or submitted any related papers from the same study (see Previous Publication, Related Manuscripts and Reports, and Preprints).

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Manuscript Style

Manuscripts should be prepared in accordance with the , 11th edition,² and/or the .⁴

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Manuscript Components

Include in the manuscript file a title page, abstract, text, references, and as appropriate, figure legends and tables. Start each of these sections on a new page, numbered consecutively, beginning with the title page. Figures should be submitted as separate files (1 file per figure) and not included in the manuscript text.

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Recommended File Sizes

We recommend individual file sizes of no more than 500 kB and not exceeding 1 MB, with the total size for all files not exceeding 5 MB (not including any video files).

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Manuscript File Formats

For submission and review, please submit the manuscript as a Word document. Do not submit your manuscript in PDF format.

Use 10-, 11-, or 12-point font size, double-space text, and leave right margins unjustified (ragged).

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Title Page

The title page should be the first page of your manuscript file. It should include a manuscript title; the full names, highest academic degrees, and affiliations of all authors (if an author's affiliation has changed since the work was done, the new affiliation also should be listed); name and complete contact information for corresponding author; and manuscript word count (not including title, abstract, acknowledgment, references, tables, and figure legends).

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Title

Titles should be concise, specific, and informative.^2(p8) Please limit the length of titles to 100 characters (including spaces) for reports of research and other major articles and 60 characters for shorter article types such as opinion articles and Letters as well as for subtitles to major articles. For scientific manuscripts, do not use overly general titles, declarative titles, titles that include the direction of study results, or questions as titles. For reports of clinical trials, meta-analyses, and systematic reviews, include the type of study as a subtitle (eg, A Randomized Clinical Trial, A Meta-analysis, A Systematic Review). For reports of other types of research, do not include study type or design in the title or subtitle. Depending on the context, avoid inclusion of specific locations (eg, state, province, or country) and specific years. To read more about titles, see the .

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Key Points

In the manuscript, include a separate section called "Key Points" before the Abstract.

This feature provides a quick structured synopsis of the findings of your manuscript (required only for research and review manuscripts), following 3 key points: Question, Findings, and Meaning. Limit this section to 75-100 words or less.

Question: Focused question based on the study hypothesis or goal/purpose. Limit to 1 sentence.

Findings: Results of the study/review. Include the design (eg, clinical trial, cohort study, case-control study, meta-analysis). Focus on primary outcome(s) and finding(s). Do not emphasize secondary outcomes. Report basic numbers only but state if results are statistically significant or not significant; do not include results of statistical tests or measures of variance (see example below). Can include 1 to 2 sentences.

Meaning: Key conclusion and implication based on the primary finding(s). Limit to 1 sentence.

Example of Research Article

Question: What is the immunogenicity of an inactivated influenza A vaccine with and without adjuvant?

Findings: In this randomized clinical trial that included 980 adults, the proportion achieving an effective antibody response was 84% with adjuvant vs 2% without adjuvant, a significant difference.

Meaning: In an influenza pandemic the use of an adjuvant with inactivated influenza A vaccine may be warranted.

Include: All Journals except JNO and JHF

Exclude: JNO and JHF

Comments: Example of Review Article

Example of Review Article

Question: What are the most effective medical treatments for adult chronic sinusitis?

Findings: In this systematic review, symptoms of chronic sinusitis were improved with saline irrigation and topical corticosteroid therapy compared to no therapy. Compared with placebo, 3-week courses of systemic corticosteroids or oral doxycycline were associated with reduced polyp size, and a 3-month course of macrolide antibiotic was associated with improved symptoms in patients without polyps.

Meaning: First-line therapy for chronic sinusitis should begin with daily topical intranasal corticosteroid in conjunction with saline irrigation; subsequent therapies should be based on the patient's polyp status and severity of symptoms.

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Abstracts

Include a structured abstract for reports of original data, meta-analyses, and systematic reviews. Abstracts should be prepared in ÌÇÐÄvlog style—see instructions for preparing abstracts below. Abstracts are not required for Editorials, Viewpoints, and special features. No information should be reported in the abstract that does not appear in the text of the manuscript. To read more about abstracts, see the .

Abstracts for Reports of Original Data:

Reports of original data should include an abstract of no more than 350 words using the headings listed below. For brevity, parts of the abstract may be written as phrases rather than complete sentences. Each section should include the following content:

Importance: The abstract should begin with a sentence or 2 explaining the clinical (or other) importance of the study question.

Objective: State the precise objective or study question addressed in the report (eg, "To determine whether..."). If more than 1 objective is addressed, the main objective should be indicated and only key secondary objectives stated. If an a priori hypothesis was tested, it should be stated.

Design: Describe the basic design of the study and include the specific study type (eg, randomized clinical trial, cohort, cross-sectional, case-control, case series, survey, meta-analysis, bibliometric analysis). State the years of the study and the duration of follow-up. For older studies (eg, those completed >3 years ago), add the date of the analysis being reported. If applicable, include the name of the study (eg, the Framingham Heart Study). As relevant, indicate whether observers were blinded to patient groupings, particularly for subjective measurements.

Setting: Describe the study setting to assist readers to determine the applicability of the report to other circumstances, for example, multicenter, population-based, primary care or referral center(s), etc.

Participants: State the clinical disorders, important eligibility criteria, and key sociodemographic features of patients (or other study participants). The numbers of eligible participants and how they were selected should be provided, including the number approached but who refused or were excluded. For selection procedures, these terms should be used, if appropriate: random sample (where random refers to a formal, randomized selection in which all eligible individuals have a fixed and usually equal chance of selection); population-based sample; referred sample; consecutive sample; volunteer sample; convenience sample. If matching is used for comparison groups, characteristics that are matched should be specified. In follow-up studies, the proportion of participants who completed the study must be indicated.

Note: The preceding 3 sections are usually combined for accepted papers during the editing process as "Design, Setting, and Participants," but for manuscript submission these sections should be kept separate.

Intervention(s) (for clinical trials) or Exposure(s) (for observational studies): The essential features of any interventions, or exposures, should be described, including their method and duration. The intervention, or exposure, should be named by its most common clinical name, and nonproprietary drug names should be used.

Main Outcome(s) and Measure(s): Indicate the primary study outcome measurement(s) as planned before data collection began. If the manuscript does not report the main planned outcomes of a study, this fact should be stated and the reason indicated. State clearly if the hypothesis being tested was formulated during or after data collection. Explain outcomes or measurements unfamiliar to a general medical readership.

Results: Summary demographic information (eg, characteristics such as sex and age) and the number of study participants should be reported in the first sentence of the Results paragraph. The main outcomes of the study should be reported and quantified, including final included/analyzed sample. When possible, present numerical results (eg, absolute numbers and/or rates) with appropriate indicators of uncertainty, such as confidence intervals. Include absolute numbers and/or rates with any ratio measures and avoid redundant reporting of relative data (eg, % increase or decrease). Use means and standard deviations (SDs) for normally distributed data and medians and ranges or interquartile ranges (IQRs) for data that are not normally distributed. Avoid solely reporting the results of statistical hypothesis testing, such as P values, which fail to convey important quantitative information. For most studies, P values should follow the reporting of comparisons of absolute numbers or rates and measures of uncertainty (eg, 0.8%, 95% CI −0.2% to 1.8%; P =.13). P values should never be presented alone without the data that are being compared. See also Reporting Standards and Data Presentation. Measures of relative risk also may be reported (eg, relative risk, hazard ratios) and should include confidence intervals. Studies of screening and diagnostic tests should report sensitivity, specificity, and likelihood ratio. If predictive value or accuracy is reported, prevalence or pretest likelihood should be given as well. All randomized clinical trials should include the results of intention-to-treat analysis as well. In intervention studies, the number of patients withdrawn because of adverse effects should be given. Approaches such as number needed to treat to achieve a unit of benefit may be included when appropriate. All surveys should include response/participation rates.

Conclusions and Relevance: Provide only conclusions of the study that are directly supported by the results. Give equal emphasis to positive and negative findings of equal scientific merit. Also, provide a statement of relevance indicating implications for clinical practice or health policy, avoiding speculation and overgeneralization. The relevance statement may also indicate whether additional study is required before the information should be used in clinical settings.

Trial Registration: For clinical trials only (not nontrial observational studies), the name of the trial registry, registration number, and URL of the registry must be included. See Trial Registration.

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Abstracts for Meta-analysis:

Manuscripts reporting the results of meta-analyses should include an abstract of no more than 350 words using the headings listed below. The text of the manuscript should also include a section describing the methods used for data sources, study selection, data extraction, and data synthesis. Each heading should be followed by a brief description:

Importance: A sentence or 2 explaining the importance of the systematic review question that is used to justify the meta-analysis.

Objective: State the precise primary objective of the meta-analysis. Indicate whether the systematic review for the meta-analysis emphasizes factors such as cause, diagnosis, prognosis, therapy, or prevention and include information about the specific population, intervention, exposure, and tests or outcomes that are being analyzed.

Data Sources: Succinctly summarize data sources, including years searched. The search should include the most current information possible, ideally with the search being conducted within several months before the date of manuscript submission. Potential sources include computerized databases and published indexes, registries, meeting abstracts, conference proceedings, references identified from bibliographies of pertinent articles and books, experts or research institutions active in the field, and companies or manufacturers of tests or agents being reviewed. If a bibliographic database is used, state the exact indexing terms used for article retrieval, including any constraints (for example, English language or human study participants). If abstract space does not permit this level of detail, summarize sources in the abstract including databases and years searched, and place the remainder of the information in the Methods section.

Study Selection: Describe inclusion and exclusion criteria used to select studies for detailed review from among studies identified as relevant to the topic. Details of selection should include particular populations, interventions, outcomes, or methodological designs. The method used to apply these criteria should be specified (for example, blinded review, consensus, multiple reviewers). State the proportion of initially identified studies that met selection criteria.

Data Extraction and Synthesis: Describe guidelines (eg, , MOOSE) used for abstracting data and assessing data quality and validity. The method by which the guidelines were applied should be stated (for example, independent extraction by multiple observers). Indicate whether data were pooled using a fixed-effect or random-effects model.

Main Outcome(s) and Measure(s): Indicate the primary study outcome(s) and measurement(s) as planned before data collection began. If the manuscript does not report the main planned outcomes of a study, this fact should be stated and the reason indicated. State clearly if the hypothesis being tested was formulated during or after data collection. Explain outcomes or measurement unfamiliar to a general medical readership.

Results: Provide the number of studies and patients/participants in the analysis and state the main quantitative results of the review. When possible, present numerical results (eg, absolute numbers and/or rates) with appropriate indicators of uncertainty, such as confidence intervals. Include absolute numbers and/or rates with any ratio measures and avoid redundant reporting of relative data (eg, % increase or decrease). Use means and standard deviations (SDs) for normally distributed data and medians and ranges or interquartile ranges (IQRs) for data that are not normally distributed. Avoid solely reporting the results of statistical hypothesis testing, such as P values, which fail to convey important quantitative information. For most studies, P values should follow the reporting of comparisons of absolute numbers or rates and measures of uncertainty (eg, 0.8%, 95% CI −0.2% to 1.8%; P = .13).&²Ô²ú²õ±è;P values should never be presented alone without the data that are being compared. See also Reporting Standards and Data Presentation. Meta-analyses should state the major outcomes that were pooled and include odds ratios or effect sizes and, if possible, sensitivity analyses. Evaluations of screening and diagnostic tests should include sensitivity, specificity, likelihood ratios, receiver operating characteristic curves, and predictive values. Assessments of prognosis should summarize survival characteristics and related variables. Major identified sources of variation between studies should be stated, including differences in treatment protocols, co-interventions, confounders, outcome measures, length of follow-up, and dropout rates.

Conclusions and Relevance: The conclusions and their applications (clinical or otherwise) should be clearly stated, limiting interpretation to the domain of the review.

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Submitted manuscripts may be reviewed with software to detect plagiarism and inappropriate duplication.

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Appeals

Authors may appeal decisions. All appeals are reviewed by the editor in chief, on a case-by-case basis, or a designated editor if the editor in chief is recused from the review.

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What to Expect

After Revision/Acceptance

Authorship Form and Publishing Agreement

All authors are required to complete an Authorship Form and Publishing Agreement. See Authorship Criteria and Contributions.

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Editing

Accepted manuscripts are edited in accordance with the ,² and returned to the corresponding author (or her/his designee) for approval. Authors are responsible for all statements made in their work, including changes made during editing and production that are authorized by the corresponding author.

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Embargo

Authors should not disclose the fact that their manuscript has been accepted to anyone, except coauthors and contributors, until it is published without permission of the editor or as described in the guidance on Previous or Planned Meeting Presentaton or Release of Information and Embargo Policy.

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Publication

What to Expect

After Publication

Corrections

Requests to publish corrections should be sent to the editorial office. Errors and requests for corrections are reviewed by editors and authors, and, if warranted, a Correction notice summarizing the errors and corrections is published promptly and linked online to the original article, and the original article is corrected online with the date of correction.¹⁵

Author CME

First and last authors of peer-reviewed articles are eligible to receive CME credit. See .

What to Expect

About Previous Release of Information, Embargo, and Access

Previous Publication, Related Manuscripts and Reports, and Preprints

Manuscripts are considered with the understanding that they have not been published previously and are not under consideration by another publication.

Copies of all related or similar manuscripts and reports by the same authors (ie, those containing substantially similar content or using the same, similar, or a subset of data) that have been previously published or posted electronically or are under consideration elsewhere must be provided at the time of manuscript submission. All related previously published articles should be cited as references and described in the submitted manuscript along with explanation of how the submitted manuscript differs from the related previously published article(s).

Manuscripts that have been previously posted on a preprint server may be submitted for consideration for publication. When the manuscript is submitted, authors must provide information about the preprint, including a link to it and a description of whether the submitted manuscript has been revised or differs from the preprint.

Previous or Planned Meeting Presentation or Release of Information

Meeting presentation: A complete manuscript submitted to the journal following or prior to presentation at a scientific meeting or publication of preliminary findings elsewhere (ie, as an abstract) is eligible for consideration for publication. Authors considering presenting or planning to present the work at an upcoming scientific meeting should indicate the name and date of the meeting on the manuscript submission form. For accepted papers, the editors may be able to coordinate publication with the meeting presentation. Authors of submitted papers, including those accepted but not yet published, should not disclose the status of such papers during such meeting presentations that occur before the work is published. Authors who present information contained in a manuscript that is under consideration by this journal during scientific or clinical meetings should not distribute complete reports (ie, copies of manuscripts) or full data presented as tables and figures to conference attendees or journalists. Publication of abstracts in print and online conference proceedings, as well as posting of slides or videos from the scientific presentation on the meeting website, is acceptable. However, for manuscripts under consideration by this journal, publication of full reports in meeting proceedings or online, issuing detailed news releases reporting the results of the study that go beyond the meeting abstract, or participation in formal news conferences will ordinarily jeopardize chances for publication of the submitted manuscript in this journal.⁵ Media coverage of presentations at scientific meetings will not jeopardize consideration, but direct release of information through press releases or news media briefings may preclude consideration of the manuscript by this journal.⁵ Rare instances of papers reporting public health emergencies should be discussed with the editor. Authors submitting manuscripts or letters to the editor regarding adverse drug or medical device reactions, reportable diseases, etc, should also report this information to the relevant government agency.

Authors should not release information about accepted manuscripts via social media until publication.

See also Previous Publication, Related Manuscripts and Reports, and Preprints. For more information, see the .

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Embargo Policy

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Editorial Policies for Authors

Author Responsibilities

All authors (ie, the corresponding author and each coauthor) must read, complete, and submit an electronic Authorship Form with required statements on Authorship Responsibility, Criteria, and Contributions; Disclosure of Potential Conflicts of Interest; and Publishing Agreement.^2(pp128-133) In addition, authors are required to identify their specific contributions to the work described in the manuscript. Requests by authors to designate equal contributions or shared authorship positions (eg, co-first authorship) may be considered if justified and within reason.⁶ An email with links to the Authorship Form will be sent to authors for completion after manuscripts have been submitted.

For reports of original data, authors' specific contributions will be published in the Acknowledgment section (see Manuscript Preparation and Submission Requirements, Acknowledgment section).² All other persons who have made substantial contributions to the work reported in this manuscript (eg, data collection, analysis, or writing or editing assistance) but who do not fulfill the authorship criteria should be named with their specific contributions and affiliations in an Acknowledgment in the manuscript. Written permission to include the names of individuals in the Acknowledgment section must be obtained.

Nonhuman artificial intelligence, language models, machine learning, or similar technologies do not qualify for authorship. If these models or tools are used to create content or assist with writing or manuscript preparation, authors must take responsibility for the integrity of the content generated by these tools. Authors should report the use of artificial intelligence, language models, machine learning, or similar technologies to create content or assist with writing or editing of manuscripts in the Acknowledgment section or Methods section if this is part of formal research design or methods. See also Use of AI in Publication and Research, Reproduced and Re-created Material, and Image Integrity.

The authors also must certify that the manuscript represents valid work and that neither this manuscript nor one with substantially similar content under their authorship has been published or is being considered for publication elsewhere (see also About Previous Release of Information, Embargo, and Access).² Authors of manuscripts reporting original data or systematic reviews must provide an access to data statement from 1 or 2 named authors, often the corresponding author (see also Data Access, Responsibility, and Analysis). If requested, authors should be prepared to provide the data and must cooperate fully in obtaining and providing the data on which the manuscript is based for examination by the editors or their assignees.

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Role of the Corresponding Author

A single corresponding author (or coauthor designee in the event that the corresponding author is unavailable) will serve on behalf of all coauthors as the primary correspondent with the editorial office during the submission and review process. If the manuscript is accepted, the corresponding author will review an edited manuscript and proof, make decisions regarding release of information in the manuscript to the news media or federal agencies, handle all postpublication communications and inquiries, and will be identified as the corresponding author in the published article.

The corresponding author also is responsible for ensuring that the Acknowledgment section of the manuscript is complete (see Acknowledgment Section) and that the conflict of interest disclosures reported in the Acknowledgment section of the manuscript are accurate, up-to-date, and consistent with the information provided in each author's potential conflicts of interest section in the Authorship Form (see Conflicts of Interest and Financial Disclosures).

The corresponding author also must complete the Acknowledgment statement part of the Authorship Form confirming that all persons who have contributed substantially but who are not authors are identified in the Acknowledgment section and that written permission from each person acknowledged has been obtained (see Acknowledgment Section).

Requests for co-corresponding authors will be considered on a very limited basis if justified, but no more than 2 co-corresponding authors will be permitted. In such cases, a primary corresponding author must be designated as the point of contact responsible for all communication about the manuscript and article, manage the tasks described above, and will be listed first in the corresponding author section.⁶ To read more about the role and responsibilities of corresponding authors, see the .

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Changes in Authorship

Authors should determine the order of authorship among themselves and should settle any disagreements before submitting their manuscript. Changes in authorship (ie, order, addition, and deletion of authors) should be discussed and approved by all authors. Any requests for such changes in authorship after initial manuscript submission and before publication should be explained in writing to the editor in a letter or email from all authors.^2(pp128-133)

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Name Change Policy

The ÌÇÐÄvlog recognizes that authors may change their names for personal reasons, and the editors respect authors' rights to autonomy and privacy in this regard. Authors who request confidential name changes after publication because of changes in identity, marital status, religion, or other reasons may have their names changed in articles without indication of the reason for the change and without a formal correction notice. If an author prefers this change to be public, a formal Correction notice can be issued, with or without the reason per author preference. The journal will not request the approval of coauthors, but the requesting author may wish to notify coauthors if this change will affect subsequent citations to the article. The requester may be asked to notify the corresponding author about this change to the published article; alternatively, the journal may inform the corresponding author of this change (without explaining the reason for the change). The journal will make this change to the online and PDF versions of the published article and will notify postpublication indexes and databases as a standard process but cannot guarantee when or if the change will be reflected in these indexes and databases.

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Group Authorship

If authorship is attributed to a group (either solely or in addition to 1 or more individual authors), all members of the group must meet the full criteria and requirements for authorship as described above, and all group member authors must complete Authorship Forms.⁶ If all members of a group do not meet all authorship criteria, a group must designate 1 or more individuals as authors or members of a writing group who meet full authorship criteria and requirements and who will take responsibility for the group.^2,6 Group names should appear at the end of the byline and should not be interspersed within the list of individually named authors. Group authors may not be included for article types with limited numbers of authors (eg, opinion articles).

For articles with a large number of authors (eg, >50), a long list of authors will not fit in the byline of a print/PDF version of the article. In such cases, a group byline will be recommended with the individual names of each author listed at the end of the article. All author names would still be individually indexed, displayed, and easily searchable in bibliographic records such as PubMed.⁶

Nonauthor Collaborators: Other group members who do not meet the criteria for authorship (eg, investigators, advisors, assistants) may be identified. For group author manuscripts, a Nonauthor Collaborator Template (with names, academic degrees, institution, location, role/contribution, and subgroup) must be completed during revision. The template will be available to authors with the request for revision. The collaborators will be published in an online Supplement based on this template and will be deposited to PubMed.

To read more about authorship, click .

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Conflicts of Interest and Financial Disclosures

A conflict of interest may exist when an author (or the author's institution or employer) has financial or personal relationships or affiliations that could influence (or bias) the author's decisions, work, or manuscript. All authors are required to report potential conflicts of interest including specific financial interests relevant to the subject of their manuscript in the Acknowledgment section of the manuscript² and in the Disclosure of Potential Conflicts of Interest section of the Authorship Form. Note: These forms will be requested after a manuscript has been submitted, but authors should also include conflict of interest disclosures in the Acknowledgment section of the submitted manuscript.

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Definitions and Terms of Conflicts of Interest Disclosures:

Authors are expected to provide detailed information about all relevant financial interests, activities, relationships, and affiliations (other than those affiliations listed in the title page of the manuscript) including, but not limited to, employment, affiliation, funding and grants received or pending, consultancies, honoraria or payment, speakers' bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Following the guidelines of the ICMJE,⁴ the definitions and terms of such disclosures include

Any potential conflicts of interest "involving the work under consideration for publication" (during the time involving the work, from initial conception and planning to present),

Any "relevant financial activities outside the submitted work" (over the 3 years prior to submission), and

Any "other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing" what is written in the submitted work (based on all relationships that were present during the 3 years prior to submission).

Authors without conflicts of interest, including relevant financial interests, activities, relationships, and affiliations, should indicate such in their disclosures and include a statement of no such interests in the Acknowledgment section of the manuscript. Failure to include this information in the manuscript may delay evaluation and review of the manuscript. Authors should err on the side of full disclosure and should contact the editorial office if they have questions or concerns.

Although many universities and other institutions and organizations have established policies and thresholds for reporting financial interests and other conflicts of interest, the ÌÇÐÄvlog requires complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value. For example, authors of a manuscript about hypertension should report all financial relationships they have with all manufacturers and owners of products, devices, tests, and services used in the management of hypertension, not only those relationships with entities whose specific products, devices, tests, and services are mentioned in the manuscript. If authors are uncertain about what constitutes a relevant financial interest or relationship, they should contact the editorial office.

For all accepted manuscripts, the corresponding author will have been asked to confirm that each coauthor's disclosures of conflicts of interest and relevant financial interests, activities, relationships, and affiliations and declarations of no such interests are accurate, up-to-date, and consistent with the disclosures reported in the Acknowledgment section of the manuscript because this information will be published in the Acknowledgment section of the article. Decisions about whether such information provided by authors should be published, and thereby disclosed to readers, are usually straightforward. Although editors are willing to discuss disclosure of specific conflicts of interest with authors, ÌÇÐÄvlog policy is one of complete disclosure of all potential conflicts of interest, including relevant financial interests, activities, relationships, and affiliations (other than those affiliations listed in the title page of the manuscript). The policy requiring disclosure of conflicts of interest applies for all manuscript submissions, including letters to the editor. If an author's disclosure of potential conflicts of interest is determined to be inaccurate or incomplete after publication, a correction will be published to rectify the original published disclosure statement, and additional action may be taken as necessary.

All authors must also complete the Disclosure of Potential Conflicts of Interest section of the Authorship Form.⁷

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Funding/Support and Role of Funder/Sponsor

All financial and material support for the research and the work should be clearly and completely identified in an Acknowledgment section of the manuscript. At the time of submission, information on the funding source (including grant identification) must also be completed via the online manuscript submission and review system. The specific role of the funding organization or sponsor in each of the following should be specified: "design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication."⁷ To read more about reporting funding and other support, see the .

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Data Access, Responsibility, and Analysis

For all reports (regardless of funding source) containing original data, at least 1 named author (eg, the principal investigator), and no more than 2 authors, must indicate that she or he "had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis."⁷ This exact statement should be included in the Acknowledgment section at the end of the manuscript. Modified statements or generic statements indicating that all authors had such access are not acceptable. In addition, for all reports containing original data, the names and affiliations of all authors (or other individuals) who conducted and are responsible for the data analysis must be indicated in the Acknowledgment section of the manuscript. If the individual who conducted the analysis is not named as an author, a detailed explanation of his/her contributions and reasons for his/her involvement with the data analysis should be included.

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Data Sharing Statement

For all reports of research, authors are required to provide a Data Sharing Statement to indicate if data will or will not be shared. Specific questions regarding the sharing of data are included in the manuscript submission system. If authors choose to share or not share data, this information will be published in a Data Sharing Statement in an online supplement linked to the published article. Authors will be asked to identify the data, including individual patient data, a data dictionary that defines each field in the data set, and supporting documentation (eg, statistical/analytic code), that will be made available to others; when, where, and how the data will be available (eg, a link to a data repository); types of analyses that are permitted; and if there will be any restrictions on the use of the data. Authors also have the option to explain why data may not be shared. A list of generalist public repositories that authors may consider using is available from the .

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Acknowledgment Section

The Acknowledgment section is the general term for the list of contributions, disclosures, credits, and other information included at the end of the text of a manuscript but before the references. The Acknowledgment section includes authors' contributions; information on author access to data; disclosure of potential conflicts of interest, including financial interests, activities, relationships, and affiliations; sources of funding and support; an explanation of the role of funder(s)/sponsor(s); names, degrees, and affiliations of participants in a large study or other group (ie, collaborators); any important disclaimers; information on previous presentation of the information reported in the manuscript; and the contributions, names, degrees, affiliations, and indication if compensation has been received for all persons who have made substantial contributions to the work but who are not authors.²

All other persons who have made substantial contributions to the work reported in the manuscript (eg, data collection, analysis, and writing or editing assistance) but who do not fulfill the authorship criteria should be named with their specific contributions in an Acknowledgment in the manuscript.

Authors must obtain written permission to include the names of all individuals included in the Acknowledgment section, and the corresponding author must confirm that such permission has been obtained in the Authorship Form.

Authors should report the use of artificial intelligence, language models, machine learning, or similar technologies to create content or assist with writing or editing of manuscripts in the Acknowledgment section or the Methods section if this is part of formal research design or methods. This should include a description of the content that was created or edited and the name of the language model or tool, version and extension numbers, manufacturer, date(s) of use, and confirmation that the authors take responsibility for the integrity of the content generated. (Note: this does not include basic tools for checking grammar, spelling, references, etc.) See also Use of AI in Publication and Research and Statistical Analysis Subsection.

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Editorial Policies for Authors

Requirements for Reporting

EQUATOR Reporting Guidelines

Authors of research articles should follow the . See specific Study Types for detailed guidance on reporting.

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Use of Causal Language

Causal language (including use of terms such as effect and efficacy) should be used only for randomized clinical trials. For all other study designs (including meta-analyses of randomized clinical trials), methods and results should be described in terms of association or correlation and should avoid cause-and-effect wording. To read more about use of causal language, see the .

Timeliness of Data

Research reports should be timely and current and should be based on data collected as recently as possible. Manuscripts based on data from randomized clinical trials should be reported as soon as possible after the trial has ended, ideally within 1 year after follow-up has been completed.

For cohort studies, the date of final follow-up should be no more than 5 years before manuscript submission. Likewise, data used in case-control or cross-sectional studies should have been collected as recently as possible, but no more than 5 years before manuscript submission. Manuscripts in which the most recent data have been collected more than 5 years ago ordinarily will receive lower priority for publication; thus, authors of such manuscripts should provide a detailed explanation of the relevance of the information in light of current knowledge and medical practice as well as the most recent date(s) of analysis of the study.

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Statistical Methods and Data Presentation

General Considerations

Authors are encouraged to consult "Reporting Statistical Information in Medical Journal Articles."¹ In the Methods section, describe statistical methods with enough detail to enable a knowledgeable reader with access to the original data to reproduce the reported results. Such description should include appropriate references to the original literature, particularly for uncommon statistical methods. For more advanced or novel methods, provide a brief explanation of the methods and appropriate use in the text and consider providing a detailed description in an online supplement.

In the reporting of results, when possible, quantify findings and present them with appropriate indicators of measurement error or uncertainty, such as confidence intervals (see Reporting Standards and Data Presentation). Avoid relying solely on statistical hypothesis testing, such as the use of P values, which fails to convey important quantitative information. For observational studies, provide the numbers of observations. For randomized trials, provide the numbers randomized. Report losses to observation or follow up (see Missing Data). For multivariable models, report all variables included in models, and report model diagnostics and overall fit of the model when available (see Statistical Procedures).

Define statistical terms, abbreviations, and symbols, if included. Avoid nontechnical uses of technical terms in statistics, such as correlation, normal, predictor, random, sample, significant, trend. Do not use inappropriate hedge terms such as marginal significance or trend toward significance for results that are not statistically significant. Causal language (including use of terms such as effect and efficacy) should be used only for randomized clinical trials. For all other study designs (including meta-analyses of randomized clinical trials), methods and results should be described in terms of association or correlation and should avoid cause-and-effect wording.

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Sample Size Calculations

For randomized trials, a statement of the power or sample size calculation is required (see the ). For observational studies that use an established population, a power calculation is not generally required when the sample size is fixed. However, if the sample size was determined by the researchers, through any type of sampling or matching, then there should be some justification for the number sampled. In any case, describe power and sample size calculations at the beginning of the Statistical Methods section, following the general description of the study population.

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Descriptive Statistics

It is generally not necessary to provide a detailed description of the methods used to generate summary statistics, but the tests should be briefly noted in the Methods section (eg, ANOVA or Fisher exact test).

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Statistical Procedures

Identify regression models with more than 1 independent variable as multivariable and regression models with more than 1 dependent variable as multivariate. Report all variables included in models, as well as any mathematical transformations of those variables. Provide the scientific rationale (clinical, statistical, or otherwise) for including variables in regression models.

For regression models fit to dependent data (eg, clustered or longitudinal data), the models should account for the correlations that arise from clustering and/or repeated measures. Failure to account for such correlation will result in incorrect estimates of uncertainty (eg, confidence intervals). Describe how the model accounted for correlation. For example, for an analysis based on generalized estimating equations, identify the assumed correlation structure and whether robust (or, sandwich) variance estimators were used. Or, for an analysis based on mixed-effects models, identify the assumed structure for the random effects, such as the level of random intercepts and whether any random slopes were included. Fixed-effects estimation should be described as conditional likelihood. Avoid the term fixed effects for describing covariates.

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Missing Data

Report losses to observation, such as dropouts from a clinical trial or those lost to follow-up or unavailable in an observational study. If some participants are excluded from analyses because of missing or incomplete data, provide a supplementary table that compares the observed characteristics between participants with complete and incomplete data. Consider multiple imputation methods to impute missing data and include an assessment of whether data were missing at random. Approaches based on "last observation carried forward" should not be used.

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Primary Outcomes, Multiple Comparisons, and Post Hoc Comparisons

Both randomized and observational studies should identify the primary outcome(s) before the study began, as well as any prespecified secondary, subgroup, and/or sensitivity analyses. Comparisons arrived at during the course of the analysis or after the study was completed should be identified as post hoc. For analyses of more than 1 primary outcome, corrections for multiple testing should generally be used. For secondary outcomes, address multiple comparisons or consider such analyses as exploratory and interpret them as hypothesis-generating. The reporting of all outcomes should match that included in study protocols. For randomized clinical trials, protocols with complete statistical analysis plans should be cited in the Methods section and submitted as online supplementary content. Randomized clinical trials should be primarily analyzed according to the intention-to-treat approach. Deviations from strict intention-to-treat analysis should be described as "modified intention-to-treat," with the modifications clearly described.

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Statistical Analysis Subsection

At the end of the Methods section, briefly describe the statistical tests used for the analysis. State any a priori levels of significance and whether hypothesis tests were 1- or 2-sided. Also include the statistical software used to perform the analysis, including the version and manufacturer, along with any extension packages (eg, the svy suite of commands in Stata or the survival package in R). Do not describe software commands (eg, SAS proc mixed was used to fit a linear mixed-effects model). If analysis code is included, it should be placed in the online supplementary content.

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Reporting Standards and Data Presentation

Analyses should follow and be consistent with the protocol and statistical analysis plan, or described as post hoc.

When possible, present numerical results (eg, absolute numbers and/or rates) with appropriate indicators of uncertainty, such as confidence intervals. Include absolute numbers and/or rates with any ratio measures and avoid redundant reporting of relative data (eg, % increase or decrease). Use means and standard deviations (SDs) for normally distributed data and medians and ranges or interquartile ranges (IQRs) for data that are not normally distributed. Avoid solely reporting the results of statistical hypothesis testing, such as P values, which fail to convey important quantitative information. For most studies, P values should follow the reporting of comparisons of absolute numbers or rates and measures of uncertainty (eg, 0.8%, 95% CI −0.2% to 1.8%; P = .13). P values should never be presented alone without the data that are being compared. If P values are reported, follow standard conventions for decimal places: for P values less than .001, report as "P<.001"; for P values between .001 and .01, report the value to the nearest thousandth; for P values greater than or equal to .01, report the value to the nearest hundredth; and for P values greater than .99, report as "P>.99." For studies with exponentially small P values (eg, genetic association studies), P values may be reported with exponents (eg, P = 1×10^−5). In general, there is no need to present the values of test statistics (eg, F statistics or χ² results) and degrees of freedom when reporting results.

For secondary and subgroup analyses, there should be a description of how the potential for type I error due to multiple comparisons was handled, for example, by adjustment of the significance threshold. In the absence of some approach, these analyses should generally be described and interpreted as exploratory, as should all post hoc analyses.

For randomized trials using parallel-group design, there is no validity in conducting hypothesis tests regarding the distribution of baseline covariates between groups; by definition, these differences are due to chance. Because of this, tables of baseline participant characteristics should not include P values or statements of statistical comparisons among randomized groups. Instead, report clinically meaningful imbalances between groups, along with potential adjustments for those imbalances in multivariable models. To read more about statistical tests and data presentation, see the .

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Reporting Demographic Information for Study Participants

Researchers are encouraged to report studies that include diverse and representative participants and to indicate participant inclusion and exclusion criteria and how the findings generalize to the population(s) that are the focus of or are compatible with the research question. Aggregate, deidentified demographic information (eg, age, sex, race and ethnicity, and socioeconomic indicators) should be reported for all research reports along all prespecified outcomes. Demographic variables collected for a specific study should be reported in the Methods section. Demographic information assessed should be reported in the Results section, either in the main article or in an online supplement or both. If any demographic characteristics that were collected are not reported, the reason should be stated. Summary demographic information (eg, baseline characteristics of study participants) should be reported in the first line of the Results section of Abstracts.

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Reporting Age

Study inclusion or exclusion criteria by age or age group should be defined in the Methods section. Stratification by age groups should be based on relevance to disease, condition, or population (eg, <5 or >65 years). The ages for study participants should be reported in aggregate (ie, mean and SD or median and IQR or range) in the Results section.

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Reporting Sex and Gender

The term sex should be used when reporting biological factors and gender should be used when reporting gender identity or psychosocial/cultural factors. The methods used to obtain information on sex, gender, or both (eg, self-reported, investigator observed or classified, or laboratory test) should be explained in the Methods section.¹² The distribution of study participants or samples should be reported in the Results section, including for studies of humans, tissues, cells, or animals. All participants should be reported, not just the category that represents the majority of the sample. Studies that address pregnancy should follow these recommendations, and if the gender identity of participants was not assessed, use the terms pregnant participants, pregnant individuals, pregnant patients, etc, as appropriate.

In research articles, follow recommendations to include all representative populations in study design, data analyses, results, and interpretation of findings. Report sex or gender of study participants, including how sex or gender was defined and assessed. Whenever possible, all main outcomes should be reported by sex or gender (or both if appropriate). In nonresearch reports, choose gender-neutral and sex-neutral terms that avoid bias, suit the material under discussion, and are not confusing to readers. See the Sex and Gender Equity in Research (SAGER) for additional guidance.

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Reporting Race and Ethnicity

The Methods section should include an explanation of who identified participant race and ethnicity and the source of the classifications used (eg, self-report or selection, investigator observed, database, electronic health record, survey instrument).

If race and ethnicity categories were collected for a study, the reasons that these were assessed also should be described in the Methods section. If collection of data on race and ethnicity was required by the funding agency, that should be noted.

Specific racial and ethnic categories are preferred over collective terms, when possible. Authors should report the specific categories used in their studies and recognize that these categories will differ based on the databases or surveys used, the requirements of funders, and the geographic location of data collection or study participants. Categories included in groups labeled as "other" should be defined.

Categories should be listed in alphabetical order in text and tables.

Race and ethnicity of the study population should be reported in the Results section.

For additional information, see "Updated Guidance on Reporting Race and Ethnicity in Medical and Science Journals" and the Summary Guide for Preferred Terms When Reporting Race and Ethnicity.

Ethical Approval of Studies and Informed Consent

For all manuscripts reporting data from studies involving human participants or animals, formal review and approval, or formal review and waiver, by an appropriate institutional review board or ethics committee is required and should be described in the Methods section.^2(p226) For those investigators who do not have formal ethics review committees, the principles outlined in the Declaration of Helsinki should be followed.¹³ For investigations of humans, state in the Methods section the manner in which informed consent was obtained from the study participants (ie, oral or written) and whether participants received a stipend. Authors of research studies involving humans should not make independent determinations of exemption or exclusion of IRB or ethical review; they should cite the institutional or regulatory policy for that determination and indicate if the data are deidentified and publicly available or protected by prior consent or privacy safeguards. Editors may request that authors provide documentation of the formal review and recommendation from the institutional review board or ethics committee responsible for oversight of the study.

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Patient Identification

A signed statement of informed consent to publish patient descriptions, photographs, video, and pedigrees should be obtained from all persons (parents or legal guardians for minors) who can be identified (including by the patients themselves) i/n such written descriptions, photographs, or pedigrees and should be submitted with the manuscript and indicated in the Acknowledgment section of the manuscript. Such persons should be offered the opportunity to see the manuscript before its submission.^2(pp229-232)

Omitting data or making data less specific to deidentify patients is acceptable, but changing any such data is not acceptable. Only those details essential for understanding and interpreting a specific case report or case series should be provided. Although the degree of specificity needed will depend on the context of what is being reported, specific ages, race/ethnicity, and other sociodemographic details should be presented only if clinically or scientifically relevant and important.² Cropping of photographs to remove identifiable personal features that are not essential to the clinical message may be permitted as long as the photographs are not otherwise altered. Please do not submit masked photographs of patients. Patients' initials or other personal identifiers must not appear in an image.

Patient Permission Form:

The Patient Permission form for publication of identifying material is available here. Translated versions in Arabic, Chinese, French, German, Hindi, Italian, Japanese, Portuguese, and Spanish are available on request.

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Use of AI in Publication and Research

AI Used in Manuscript Preparation

When traditional and generative AI technologies are used to create, review, revise, or edit any of the content in a manuscript, authors should report in the Acknowledgment section the following:

• Name of the AI software platform, program, or tool
• Version and extension numbers
• Manufacturer
• Date(s) of use
• A brief description of how the AI was used and on what portions of the manuscript or content
• Confirmation that the author(s) take responsibility for the integrity of the content generated

Note this guidance does not apply to basic tools for checking grammar, spelling, references, and similar.

AI Used in Research

When AI (eg, large language model [LLM] or natural language processing [NLP], supervised or unsupervised machine learning [ML] for predictive/prescriptive or clustering tasks, chatbots, or similar other technologies) is used as part of a scientific study, authors should:

• Follow relevant reporting guidelines for specific study designs when they exist and report each recommended guideline element with sufficient detail to enable reproducibility.
• Avoid inclusion of identifiable patient information in text, tables, and figures.
• Be aware of copyright and intellectual property concerns.
• If content protected by copyright was entered into the AI model by authors, include a copy of the permission or license from the copyright owner and describe this permission/license in the Methods section.
• If content (text, images, multimedia) generated by AI is included in a submitted manuscript or supplemental material, indicate rights or permissions to publish that content as determined by the AI service or owner in the Methods section or in the legend(s) of any AI-generated figures or multimedia.

Also address the following:

Methods Section

• Include the study design and, if a relevant reporting guideline exists, indicate how it was followed, with sufficient detail to enable reproducibility.
• Describe how AI was used for specific aspects of the study (eg, to generate or refine study hypotheses, assist in the generation of a list of adjustment variables, create graphs to show visual relationships).
• For studies using LLMs, provide the name of the platform or program, tool, version, and manufacturer; specify dates and prompt(s) used and their sequence and any revisions to prompts in response to initial outputs.
• For studies reporting ML and algorithm development, include details about data sets used for development, training, and validation. Clearly state if algorithms were trained and tested only on previously collected or existing data sets or if the study includes prospective deployment. Include the ML model and describe the variables and outcome(s) and selection of the fine-tuning parameters. Describe any assumptions involved (eg, log linearity, proportionality) and how these assumptions were tested.
• Indicate the metric used to evaluate the performance of the algorithms, including bias, discrimination, calibration, reclassification, and others as appropriate.
• Indicate the methods used to address missing data.
• Indicate institutional review board/ethics review, approval, waiver, or exemption.
• Describe methods or analyses included to address and manage AI-related methodologic bias and inaccuracy of AI-generated content.
• Indicate, when appropriate, if sensitivity analyses were performed to explore the performance of the AI model in vulnerable or underrepresented subgroups.
• Provide a data sharing statement, including if code will be shared.

Results Section

• When reporting comparisons, provide performance assessments (eg, against standard of care), include effect sizes and measures of uncertainty (eg, 95% CIs) and other measurements such as likelihood ratios, and include information about performance errors, inaccurate or missing data, and sufficient detail for others to reproduce the findings.
• Report the results of analyses to address methodologic bias and population representation.
• If examples of generated text or content are included in tables or figures, be sure to indicate the source and licensing information, as noted above.

Discussion Section

• Discuss the potential for AI-related bias and what was done to identify and mitigate such bias.
• Discuss the potential for inaccuracy of AI-generated content and what was done to identify and manage this.
• Discuss generalizability of findings across populations and results of analyses performed to explore the performance of the AI model in vulnerable or underrepresented subgroups.

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Personal Communications and Unpublished Data

A signed statement of permission should be included from each individual identified as a source of information in a personal communication or as a source for unpublished data, and the date of communication and whether the communication was written or oral should be specified.^2(p199) Personal communications should not be included in the list of references but added to the text parenthetically.

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Manuscripts That Pose Security Risks

Authors and reviewers are expected to notify editors if a manuscript could be considered to report dual use research of concern (ie, research that could be misused by others to pose a threat to public health and safety, agriculture, plants, animals, the environment, or material).¹⁴ The editor in chief will evaluate manuscripts that report potential dual use research of concern and, if necessary, consult additional reviewers.

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Journal Policies, Forms, Resources

Journal Policies

Decisions and Management of Editorial Conflicts of Interest

Final decisions regarding manuscript publication are made by the editor in chief or a designated editor who does not have any relevant conflicts of interest. The journal has a formal recusal process in place to help manage potential conflicts of interest of editors. In the event that an editor has a conflict of interest with a submitted manuscript or with the authors, the manuscript, review, and editorial decisions are managed by another designated editor without a conflict of interest related to the manuscript.

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Publishing Agreement

References

• 1. Cummings P, Rivara FP. Reporting statistical information in medical journal articles. Arch Pediatr Adolesc Med. 2003;157(4):321-324. doi:10.1001/archpedi.157.4.321

• 2. Iverson C, Christiansen S, Flanagin A, et al. AMA Manual of Style: A Guide for Authors and Editors. 11th ed. Oxford University Press; 2020.

• 3. Golub RM. Correspondence course: tips for getting a letter published in JAMA. JAMA. 2008;300(1):98-99. doi:10.1001/jama.300.1.98

• 4. International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Updated May 2023. Accessed May 18, 2023.

• 5. Fontanarosa PB, Flanagin A, DeAngelis CD. Update on JAMA's policy on release of information to the public. JAMA. 2008;300(13):1585-1587. doi:10.1001/jama.300.13.1585

• 6. Fontanarosa P, Bauchner H, Flanagin A. Authorship and team science. JAMA. 2017;318(24):2433-2437. doi:10.1001/jama.2017.19341

• 7. Fontanarosa PB, Flanagin A, DeAngelis CD. Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded studies. JAMA. 2005;294(1):110-111. doi:10.1001/jama.294.1.110

• 8. DeAngelis CD, Drazen JM, Frizelle FA, et al; International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292(11):1363-1364. doi:10.1001/jamainternmed.2014.6933

• 9. DeAngelis CD, Drazen JM, Frizelle FA, et al; International Committee of Medical Journal Editors. Is this clinical trial fully registered? a statement from the International Committee of Medical Journal Editors. JAMA. 2005;293(23):2927-2929. doi:10.1001/jama.293.23.jed50037

• 10. The CONSORT Group. The CONSORT statement. Updated 2014. Accessed September 23, 2016.

• 11. American Association for Public Opinion Research. Best practices for survey research. Accessed March 23, 2023.

• 12. Clayton JA, Tannenbaum C. Reporting sex, gender, or both in clinical research? JAMA. 2016;316(18):1863-1864. doi:10.1001/jama.2016.16405

• 13. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human participants. JAMA. Published online October 19, 2024. doi:10.1001/jama.2024.21972

• 14. Journal Editors and Authors Group. Statement on scientific publication and security. Science. 2003;299(5610):1149. . Published correction appears in Science. 2003;299(5614):1845.

• 15. Christiansen S, Flanagin A. Correcting the medical literature: "to err is human, to correct divine." JAMA. 2017;318(9):804-805. doi:10.1001/jama.2017.11833

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Last Updated: November 20, 2024