Editor in Chief DONALD Y. M. LEUNG, MD, PhD
Managing Editor GEORGE WOODWARD
Senior Journal Manager LAURA DINKINS-WHITE

All manuscripts must be submitted online through the JACI's Elsevier Editorial System (EES) Web site at http://ees.elsevier.com/jaci/. Electronic files of the manuscript contents must be uploaded at that Web site, and the onscreen steps should be followed to submit the manuscript to the Editorial Office.

Items pertaining to manuscripts submitted for publication should be sent to:

The Journal of Allergy and Clinical Immunology
Editorial Office
National Jewish Health
1400 Jackson St., Suite K012k
Denver, CO 80206

Telephone: (303) 398-1963
Fax: (303) 270-2269
Email: jaci@njhealth.org

This document contains complete guidelines for the preparation of your manuscript. For instructions regarding statistical analyses and reporting and for special instructions regarding (a) submissions having to do with allergen identification or allergen structure and (b) submissions having to do with animal models, see "Special Instructions" (below). For instructions regarding online submission, please visit http://support.elsevier.com/app/answers/detail/a_id/116. Technical support is available by email at jacistaff@njhealth.org. In any correspondence, please provide the corresponding author's name, title of the manuscript, manuscript number (if assigned), and a clear description of the problem.

Please note:
(A) To be listed as an author, an individual must meet the requirements approved by the International Committee of Medical Journal Editors (ICMJE). In order to be included in the list of authors, an individual must have done all of the following: (1) made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; (2) drafted the article or reviewed it critically for important intellectual content; and (3) given final approval of the version to be published.
(B) The JACI does not allow "ghostwriting," or uncredited authorship. All writers of a manuscript should be clearly identified.
(C) Statements and opinions expressed in the articles and communications in the Journal are those of the author(s) and not necessarily those of the Editor(s) or publisher, and the Editor(s) and publisher disclaim any responsibility or liability for such material. Neither the Editor(s) nor the publisher guarantee, warrant, or endorse any product or service advertised in this publication, nor do they guarantee any claim made by the manufacturer of such product or service.

Article Types

The Journal will consider publication of several types ofmanuscripts:

A. Original articles. These should describe fully, but as concisely as feasible, the results of original clinical and/or laboratory research. Special note regarding case studies: Case studies will be considered for publication only in the Letters to the Editor section of the Journal.

The average Original Article fills 7 pages in the printed journal, although manuscripts that exceed this may be occasionally accepted for publication at the Editors' discretion. In general, an Original Article should not exceed 3500 words, not including the abstract, figure legends, and references. Abstracts should be 250 words or less. If possible, each figure legend should be held to 60 words or less. Each Original Article may be accompanied by no more than 8 graphic presentations (tables and/or figures)-for example, 3 tables + 5 figures. (Additional text, tables, or figures can be designated as "supplemental" material, which will be included in the JACI's Online Repository. For more on this option, please see the "Online Repository Materials" section below.) Please note: Original Article manuscripts that are determined to significantly exceed these limits, or that do not include all of the elements listed below, may be returned to the authors for revision prior to review.

The title page, abstract, Capsule Summary, key words, abbreviations, text,acknowledgments, references, tables and figure legendsshould be included in one word-processing file (in .docor .wpd format). Figures should be loaded as separate filesin the format specified below.

1. Title page. The title page, abstract, clinical implications or key messages, Capsule Summary, key words, abbreviations, text, acknowledgments, references, tables, and figure legends should be included in one word-processing file (in .doc or .docx format). Figures should be loaded as separate files in the format specified below.

• Keep the title succinct: Limit it to 12 words or fewer.
• Communicate a single subject or idea in the title.
• Construct the title around the article's key words.
• Include the specific symptom, condition, intervention, mechanism, or function of the paper's central focus.
• Mention any defining population, age, gender, or animal species that distinguishes the work.
• Use terms that are specific rather than general (e.g., "penicillin" rather than "betalactam antibiotic") and include terms that clarify (e.g., "CXCR4" rather than "chemokine receptors").
• Avoid using strong words (such as "robust," "innovative," "significant," "vigorous," and "aggressive"), as they may suggest exaggerated or unwarranted claims.
• Use wit carefully and appropriately; be informative first and clever second. Although a universally understood pun can work well to attract interest, ensure that it will not confuse or mislead the reader.

The title should be followed by:

• The list of authors, including their full names, highest academic degrees, and institutional affiliations. Please see the guidelines above regarding which contributors should be included in the author list.
• The name, address, telephone number, fax number, and email address of the author who should be contacted regarding the manuscript following its publication. Note: A different author may be designated as the Corresponding Author in EES for the duration of the submission and review processes.
• A declaration of all sources of funding for the research reported in the manuscript.
  

  Note regarding National Institutes of Health-sponsored research: The JACI'S publisher, Elsevier, facilitates author posting in connection with the posting request of the NIH (referred to as the NIH "Public Access Policy"; see http://publicaccess.nih.gov/). If an author indicates that the research reported in their article was sponsored by the NIH, either by checking the appropriate box on the Transfer of Copyright form or by completing the relevant field during the online submission process, Elsevier will send the accepted version of the manuscript to PubMed Central (PMC) for public access posting 12 months after final publication. Please note that the accepted version of the manuscript does not include changes that are made during the review of galley proofs. For more information about PubMed Central, please visit http://www.ncbi.nlm.nih.gov/pmc/about/faq/.

• Background: What is the major problem that prompted the study?
• Objective: What is the purpose of the study?
• Methods: How was the study done?
• Results: What are the most important findings?
• Conclusion: What is the most important conclusion drawn?

3. Clinical Implications or Key Messages. Provide ONE of the following:

either
• a very brief paragraph (consisting of no more than 30 words) summarizing the diagnostic, therapeutic, or management implications of the article. The heading for this paragraph should be Clinical Implications.

or
• (if the article is mechanistic) two or three independent bulleted statements that present the key findings or concepts in the article and comment on their implications. The heading for this small set of bulleted statements should be Key Messages.

4. Capsule summary. The Table of Contents entry for each Original Article published in the Journal includes a short summary that encapsulates the report's findings for a clinically oriented audience. To create this summary, the authors must compose one or two brief sentences (totaling no more than 35 words) that describe the article's contribution to the literature. These sentences should succinctly state why the article is important and compelling and what relevance it has for the clinician.

5. Key words. A list of up to ten key words should followthe Capsule Summary.

6. Abbreviations. Provide a list of any abbreviations/acronyms and their definitions following the key words. Only standard abbreviations are to be used. If you are uncertain whether an abbreviation is considered standard, consult Scientific Style and Format by the Council of Science Editors or the AMA's Manual of Style. A laboratory or chemical term or the name of a disease process that will be abbreviated must be spelled out at first mention, the acronym or abbreviation following in parentheses.

7. Text. The manuscript should be written in clear and concise English. Authors whose primary language is not English should obtain assistance with writing to avoid grammatical problems. The text should be organized in sections as follows: Introduction, Methods, Results, and Discussion. Each section should begin on a new page. The generic terms for all drugs and chemicals should be used.

In studies involving human subjects, a statement describing approval by the appropriate Institutional Review Board is required. Studies involving experimental animals must include a statement in the Methods section indicating which guidelines were followed for the care and use of the animals (e.g., the "Principles of Laboratory Animal Care" formulated by the National Society for Medical Research or the "Guide for the Care and Use of Laboratory Animals" prepared by the Institute of Laboratory Animal Resources, National Research Council, and published by the National Academy Press [revised 1996]).

8. Acknowledgments. General acknowledgments for consultations, statistical analyses, and the like should be listed at the end of the text, including full names of individuals involved. However, as noted above, acknowledgment of funding should be listed on the title page.

9. References. It is the Editors' expectation that authors will perform a comprehensive search of the literature to gather the most current articles relative to the subject matter. All references that are five years old or more should be replaced with current literature, unless the referenced publication is a classic work that underscores the core subject.

References should follow "Vancouver style." See the examples below, or http://www.nlm.nih.gov/bsd/uniform_requirements.html for more information. Manuscripts in preparation, personal communications, and other unpublished information should not be cited in the reference list but may be mentioned in the text in parentheses. The references must be identified in the text by superscript Arabic numerals and numbered in consecutive order as they are mentioned in the text. The list of references, in numeric sequence, should be typed at the end of the article. In the submitted version of the manuscript, references should not appear as footnotes or endnotes, and if you have used a program such as EndNote or Reference Manager to create them, the links between the reference numbers and the citations must be removed using the following steps:

(1) Using the "Select All" feature (Ctrl-A for PCs. Cmd-A for Macs), highlight the entire text of the file, including the references.
(2) Use the keystroke command Ctrl-6 for PCs or Cmd-6 for Macs.
(3) Save. This will remove the links (permanently) without disturbing the reference numbers or the citations. It is recommended that you save one copy of your manuscript with the EndNote links in place (for your reference) and one copy of your manuscript without the EndNote links (for submission purposes).

Please note that inclusive page numbers are required. List all authors' names when there are six or fewer; when there are seven or more, list the first six and add "et al."

Examples of Reference Formatting

Journal article:
Parkin DM, Clayton D, Black RJ, Masuyer E, Friedl HP, Ivanov E, et al. Childhood leukaemia in Europe after Chernyobyl: 5-year follow-up. Br J Cancer 1996;73:1006-12.

Book:
Ringsven MD, Bond D. Gerontology and leadership skills for nurses. 2nd ed. Albany (NY): Delmar Publishers; 1996.

Chapter in a book:
Phillips SJ, Whisnant JP. Hypertension and stroke. In: Laragh JH, Brenner BM, editors. Hypertension: pathophysiology, diagnosis, and management. 2nd ed. New York: Raven Press; 1995. p. 465-78.

Internet resource:
US positions on selected issues at the third negotiating session of the Framework Convention on Tobacco Control. Washington, DC: Committee on Government Reform; 2002. Available at: http://www.house.gov/reform/min/inves_tobacco/index_accord.htm. Accessed March 4, 2002.

B. Letters to the Editor. Letters to the Editor are brief reports of clinical or laboratory observations, substantiated by controlled data but limited in scope, and without sufficient depth of investigation to qualify as Original Articles. Like Original Articles, these manuscripts are subject to peer review. Letters to the Editor are indexed in Medline, accessible to literature searches, and cited like original articles.

A Letter to the Editor must:

(1) Be brief. The average Letter to the Editor fills 2 pages in the printed journal, although manuscripts that exceed this may be occasionally accepted for publication at the Editors' discretion. In general, a Letter to the Editor should not exceed 1000 words, not including the figure legend(s) and references. If possible, the figure legend(s) should be held to 60 words or less. Please note: Letter to the Editor manuscripts that are determined to significantly exceed these limits may be returned to the authors for shortening prior to review.
(2) Have a short, relevant title. Please see the suggestions that appear above (under "A. Original Articles").
(3) Have a complete title page (see section A1).
(4) Be accompanied by a short summary that encapsulates the report's findings for a clinically oriented audience (see section A4).
(5) Begin with the salutation "To the Editor:"
(6) Close with the author's name(s), academic degree(s), institutions(s), and location(s).
(7) Have no more than nine references.
(8) List the references as complete bibliographic citations following the closure of the letter (see section A9 above for formatting).
(9) Present lists of Key words, as relevant (see sections A5 and A6 above).
(10) Be limited to a total of 2 figures and/or tables. (Additional figures or tables may be placed in the article's Online Repository; please see the relevant section below.)

C. Correspondence and Replies. Correspondence concerning recent publications in the Journal will be considered for publication and accepted based on their pertinence, their scientific quality, and available space in the Journal. If the correspondence is considered acceptable, a response will be requested from the authors of the referenced JACI article. Upon review and approval by the Editor, the Correspondence and relevant Reply will both be published together.

Both Correspondence and Reply manuscripts must:
(1) Be no longer than 500 words.
(2) Have a short, relevant title, distinct from the title of the referenced article. Please note that all Replies should have the title "Reply to [Corresponding author's name]."
(3) Have a complete title page (see section A1).
(4) List the references as complete bibliographic citations at the end of the letter with the journal article being discussed as the first reference (see section A9 for formatting). The total number of references should be no more than seven. Replies should include the Correspondence to which they are replying as one of the references.
(5) Have no more than one graphic presentation (table or figure). (See the section on Graphic Presentations below).
(6) Begin with the salutation "To the Editor:" and close with the author's name(s), academic degree(s), institutions(s), and location(s).

D. Review articles. Review articles published in the Journal are invited by the Editors.. Proposals for review articles may be emailed to the Editorial Office (jaci@njhealth.org), but current space constraints do not usually allow for the acceptance of unsolicited review manuscripts.

E. Rostrum articles. Opinion articles about subjects of particular interest and/or debate may be accepted for peer review after preliminary review by the Editor.Proposals for rostrum articles may be emailed to the Editorial Office (jaci@njhealth.org); they will be evaluated based on level of interest, novelty, and the current needs of the Journal.

Formatting of Articles

Basic Formatting
All sections, including references, should be double-spaced, with margins of at least one inch on all sides. On each page, the last name of the first author and the page number should appear in the upper right corner. Begin numbering with the title page as page 1. (Page numbering can be added from the Insert menu of word processing programs.) Be sure to display line numbers (1, 2, 3, and so forth) in the left margin of the manuscript. (Line numbering can be added from the Page Setup or Format menu of word processing programs.) The line numbering should be continuous throughout the entire manuscript, from the title page through final page (i.e., do not begin numbering from 1 again at the top of each page).

Graphic Presentations
The total number of graphic presentations (tables and/or figures) per manuscript should comply with the limits for the manuscript's Article Type (see above); requests to include additional graphics must be approved by the Editors.

A. Tables. If tables appear in the manuscript, they must be included in the electronic submission. They may be placed within the manuscript file or loaded as separate files (in .doc or .docx format). Tables should supplement, not duplicate, the text; they should be on separate pages, one table per page, and should be numbered with Roman numerals in order of mention. A brief title should be provided directly above each table. Any abbreviations should be defined at the bottom of the table. When creating a table, use the word-processing program's table formatting feature; otherwise, use only tabs (not spaces) to align columns.

B. Figures. If illustrations appear in the manuscript, they must be submitted in electronic format along with the rest of the manuscript. Each figure should be submitted as a separate electronic file, and should not be inserted into the file containing the text of the manuscript. Information regarding acceptable file formats can be found at http://www.elsevier.com/framework_authors/Artwork/Artwork_2010.pdf.

Note regarding figure legends: Figure legends should be listed in the manuscript file, on a separate page after the tables. They should not appear in the figure files. The figure legend will be included when sizing the figure and its length must therefore be taken into consideration. The figure title should appear at the beginning of each legend. The legends themselves should be succinct (no more than 60 words), identifying the data or subject being presented, but not explaining methods or results.

Basic guidelines:

• Text within the figure should be in Times New Roman font. Keep a consistent font size throughout each figure, and for all figures.
• Images need to be easily readable with good contrast, particularly figures that have multiple parts and/or a lot of different symbols or components. Clarity and consistency should be uniform among the parts of a multi-part figure, and among all the figures in a manuscript.
• In colorizing your figure(s), we ask that you keep in mind that some of our readers are colorblind and may be unable to distinguish different colors easily. To accommodate these readers, we suggest that you consider some type of aid, such as labeling each column of a bar graph with an identifier or providing a key with differently shaped symbols to identify each set of data. It is also helpful to use colors of varying intensity so that they are distinguishable as different shades of gray when viewed by the colorblind. It is important that you submit all figures in the dimensions in which they are to be published in the journal. They must be sized to the smallest dimensions that allow legibility and clarity without undue use of space.

The Journal will consider posting ancillary materials (non-essential text, tables, figures, appendices, questionnaires, etc.) in an Online Repository (OR) on the JACI Web site (http://www.jacionline.org). The OR is for peer-reviewed material that cannot be included in the print version of an article due to space considerations. In the manuscript text, materials that are housed in the OR must be referenced specifically ("see Figure E1 in the Online Repository"). Note: OR material consisting of 15 pages or less is built directly into the downloadable PDF of the manuscript.

On an individual basis, the Editors will determine whether ancillary material submitted in support of a manuscript is warranted. In some instances, an Editor may suggest when requesting a revision that part of the data be presented for the OR and removed from the manuscript, perhaps at the request of the reviewers.

The ancillary material must be submitted in EES simultaneously with the rest of the manuscript. The OR material should be loaded as separate files, and should follow the end of the regular manuscript. For revisions that will include newly designated OR material, the Marked Manuscript should show where materials were removed from the original version, and include appropriate statements directing readers of the article in the print journal to the OR. The Unmarked Manuscript will reflect the latter changes. Guidelines for Online Repository text:

• All text files for the OR should be formatted per directions for regular manuscript materials (see section A).
• If citations are made within the ancillary material, a list of references, separate from the manuscript's references, must be included and labeled E1, E2, etc.
• Authors may repeat sentences or references in the OR that are included in the manuscript, if necessary for reader comprehension.

• Tables for the OR should be submitted as files with any of the following extensions: doc, .csv, .txt,.rtf, .xls, or .ppt. The tables must have been created in the same format that they are saved, so that they can be copyedited if needed.
• Figures for the OR do not need to conform to the print specifications for resolution, but they do need to appear clear and crisp when viewed electronically.
• Figures and Tables must be designated as Figure E1, Table E1, etc, and should be numbered separately from the illustrations in the manuscript proper.

Signed Transfer of Copyright documents, Conflict of Interest disclosures, and permissions forms (when applicable) must be received in the Editorial Office before an accepted manuscript can be sent to the publisher. These forms can be faxed to 303-270-2269 or, if they have an electronic signature, they can be uploaded electronically with your manuscript submission. Templates of the forms are available for downloading from the EES Web site (http://ees.elsevier.com/jaci/img/forms.html). (If you are submitting your Transfer of Copyright and Conflict of Interest disclosure forms to us as part of your electronic submission in EES, please be sure to include all of these forms with each subsequent version of your manuscript.)

1. Transfer of Copyright. Items are accepted for publication on the understanding that they are contributed solely to the Journal of Allergy and Clinical Immunology and have not been or will not be published elsewhere except in abstract form. Each author must sign a Transfer of Copyright statement, using the exact wording provided in the downloadable form that is available at the EES Web site (http://ees.elsevier.com/jaci/img/copyright_JACI.doc). For information regarding our publisher's copyright policies, including a list of rights that are retained by the authors, please see http://www.elsevier.com/wps/find/authorsview.authors/rights.

2. Conflict of Interest Disclosure. The Journal requires all of the authors of a manuscript to acknowledge, on the title page of the manuscript, all funding sources that supported their work. In addition, the Editors require that the authors disclose all pertinent information about their other interests that could influence how the work is perceived and understood. This information must be provided through use of the International Committee of Medical Journal Editors (ICMJE) Form for Disclosure of Potential Conflicts of Interest. No article can be published in the Journal unless a completed and signed ICMJE Form has been received from each author. A copy of the form can be downloaded from the EES Web site (http://ees.elsevier.com/jaci/img/YMAI_COI_form.pdf).

3. Permission to Reuse Previously Published Material/Informed Consent Releases. If applicable, authors of manuscripts submitted to the JACI must provide the Editorial Office with proof of permission to reuse any previously published material that has appeared in another publication. Additionally, in the case of photographs of identifiable persons, a signed release showing informed consent must be provided. Because articles appear in both the print and online versions of the journal, wording in the permissions form/release should specify "permission to publish in all forms and media." Upon obtaining written permission to reuse the specified material, forward the documentation to the Editorial Office by email (jaci@njhealth.org), or fax a copy to 303-270-2269. Acceptance of a manuscript is conditional upon receipt of permission.
Please note: It sometimes takes up to 6-8 weeks to obtain permissions from a publisher, so be sure to allow plenty of time.

4. Other Documentation

• Nucleotide Sequence Data. When manuscripts include or describe original sequence data, authors must submit these data to GenBank. A footnote must include the accession number under which the data were submitted. Instructions are available from http://www.ncbi.nlm.nih.gov/Genbank or http://www.ebi.ac.uk/embl/Submission.
• Protein Sequence Data. When manuscripts include or describe original protein sequence data, authors must submit these data to Protein Identification Resource (PIR). A footnote must include the accession number under which the data were submitted. Instructions are available from http://pir.georgetown.edu.

As with new submissions, revisions must be submitted electronically through EES (http://ees.elsevier.com/jaci/). Ensure that the revised manuscript is prepared in accordance with the Journal's format and style for the type of article being revised. Please refer to the "Tutorial for Authors" (http://support.elsevier.com/app/answers/detail/a_id/116) for additional information. Adherence to these guidelines is important to prevent a delay in processing the revised manuscript.

Revisions must include the following:
(1) A Responses to Comments document that includes point-by-point responses to the comments made by the Reviewers, Editor, and Editorial Office. In your Responses to Comments document, reproduce each comment verbatim and in its entirety and follow the comment with your detailed response. Each of the comments should be preceded by the word "COMMENT," and the font style for each comment should be bold. Each of your responses should be preceded by the word "RESPONSE," and the font style for each response should be regular (not bold). In each response, indicate where relevant changes have been made in the manuscript or explain why no changes would be appropriate. If any alterations have been made to your figures or if any figures have been removed or replaced, describe the changes.
(2) A Marked Manuscript. The Marked Manuscript should be a version of your revised manuscript in which all of the ways in which it is different from the original manuscript are indicated for the sake of the Editor. The preferred method of indicating changes is Microsoft Word's Track Changes feature. Alternately, any text that has been added should be underlined, and any text that was deleted should be indicated by strikethrough formatting. Any table that was part of your original submission should be either embedded within the Marked Manuscript or provided as a separate file (e.g., "Table II - Marked"); if changes have been made to the table, they should be indicated. Likewise, any figure that was part of your original submission should be either embedded within the Marked Manuscript or provided as a separate file (e.g., "Figure 1 - Marked"); if changes have been made to the figure, they should be described in your Responses to Comments document. Line numbering (continuous) should be used throughout the Marked Manuscript.
(3) An Unmarked Manuscript. The Unmarked Manuscript should be your revised manuscript just as you intend it for publication (if it is accepted). Any table that is to be part of your revised manuscript should be either embedded within the Unmarked Manuscript or provided as a separate file (e.g., "Table II - Unmarked"). Any figure that is to be part of your revised manuscript must be provided as a separate file (e.g., "Figure 1-Unmarked").
(4) Signed Transfer of Copyright and Conflict of Interest Disclosure forms. If you are submitting your Transfer of Copyright and Conflict of Interest disclosure forms to us as part of your electronic submission in EES, please be sure to include all of these forms with each subsequent revision of your manuscript.

Special Instructions

A. The following are special instructions regarding submissions on allergen identification/structure:
(1) The allergen nomenclature must comply with the requirements of the WHO/IUIS Sub-Committee on Allergen Nomenclature, and the allergen must have been assigned a name by the Committee. Application forms are available at http://www.allergen.org.
(2) For protein allergens: Information must be included on the protein family (where possible) to which the allergen belongs (Pfam designations, http://pfam.sanger.ac.uk), the allergen function (if known), and protein identifiers (accession number[s] and/or Protein Database code[s]).Any carbohydrate determinant that may be involved in IgE responses, has functional activity, or is of biological or clinical significance in allergic disease should be identified.
(3) Priority for publication will be given to studies that increase the understanding of the mechanisms of allergic sensitization and/or improve the ability to properly diagnose or treat allergic diseases.
(4) Priority will also be given if the submission provides evidence of biological activity beyond IgE binding in vitro - for example, mechanistic or functional assays, cellular assays, basophil histamine release, environmental exposure assays, and, where possible, in vivo studies of allergenicity.

Reference:
Chapman MD, Pomes A, Breiteneder H, Ferreira F. Nomenclature and structural biology of allergens. J Allergy Clin Immunol 2007:119:414-420.

B. The following are special instructions regarding submissions using animal models:

(1) Animal model studies of interest to the JACI. The Editors would be interested in an animal-model study only if it highlights a new conceptual advance using an experimental approach that would be very difficult, impractical, or unethical to do in human beings. The authors should clearly indicate in their cover letter how their animal-model study meets these criteria.
(2) Mouse pulmonary function tests. The JACI's policy is that measurement of airway responsiveness by unrestrained, single-chamber barometric plethysmography (the Penh method) must be confirmed by invasive techniques. For further explanation of this policy, please see Finkelman FD. J Allergy Clin Immunol 2008;121:334-5.
(3) The JACI encourages authors of animal-model papers to consult and adhere to the ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines, available at http://www.nc3rs.org.uk/ARRIVE.

C. The following are instructions regarding statistical analyses and reporting for JACI manuscripts:
Although referees with statistical expertise typically review manuscripts submitted to the JACI, the Editorial Board decided that the quality of the manuscripts could be improved by providing authors some guidance on statistical analyses and reporting. Therefore, the JACI Statistical Editor has constructed the following guidelines, which incorporate many comments from Editorial Board members and statistical referees.

1. METHODS: Reporting on Statistical Methods. The Consolidated Standards of Reporting Trials (CONSORT) statement is a set of guidelines for reporting on the methods and results of randomized and nonrandomized medical research studies. It is available at the following Web site: http://www.consort-statement.org.

The first CONSORT statement provides a checklist of items that should be included in a manuscript that reports the results of a randomized clinical trial (RCT). Items 7 through 12 of the checklist are relevant to the statistical methods section for a manuscript submitted to the JACI based on a RCT. Thus:

With respect to item 12, the statistical methods and commercial software should be cited.

Item 7 and item 12 of the checklist are relevant to the Statistical Methods section of a manuscript submitted to the JACI based on a nonrandomized study. Thus:

2. Results.
Items 13 through 19 of the CONSORT checklist describe items that are important to the Results section for a manuscript submitted to the JACI based on a RCT (some of the items might not be relevant if the study is nonrandomized). Thus:

2A. Results: Descriptive Statistics at Baseline
If the distribution for a continuous variable is approximately normally distributed, then report either• the sample mean and the sample standard deviation
or
• the sample mean and the 95% confidence interval for the population mean.

If the distribution for a continuous variable is known (or suspected) to be non-normal, then report either• the sample median and the sample interquartile range
or
• the sample median and the sample first and third quartiles.

Many blood and urine measurements are log-normally distributed-i.e., the log-transformed variable is approximately normally distributed. If the distribution for a continuous variable is known (or suspected) to be lognormal, then an alternative to sample medians and quartiles is to report either
• the sample geometric mean (calculate as the exponentiation of the sample mean of the natural log-transformed data) and the sample coefficient of variation
or
• the sample geometric mean and the 95% confidence interval.

If the distribution of the variable is categorical, then report the raw numbers and the percentages for the categories. Do not use more than three digits for the percentages-i.e., 79% or 79.3% are fine, but 79.32% is not.

Statistical tests, along with reported P values, for comparing groups at baseline are not necessary unless there is a strong reason to include them.

2B. Results: Outcomes
Every P value should be reported using two digits after the decimal point. If each of the first two digits after the decimal point is zero, then a third digit can be used. If each of the first three digits after the decimal point is zero, then simply report P < .001.

If the P value is close to the level to be used for claiming a statistical significance or if each of the first two digits after the decimal point is zero, then a third digit can be used. For example, if the significance level is 0.05, then P = .046 or P = .054 can be reported. Nonsignificant results (e.g., where the P value is >0.05) should be accompanied by P values; it should not simply be stated that they are nonsignificant (NS).

P values alone are not sufficient to report the results of statistical tests. The JACI'S readers need to see the magnitude of the effects via point estimates and 95% confidence intervals for the group comparisons.

An estimate of odds ratios and relative risks (and their corresponding confidence interval estimates) should not exceed two digits beyond the decimal point.

The following is an excellent article that discusses many of the statistical errors that arise in immunologic research:
Murphy JR. Statistical errors in immunologic research. J Allergy Clin Immunol 2004;114:1259-63.

The following is an excellent article that discusses the reporting of subgroup analyses in clinical research:Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine-reporting of subgroup analyses in clinical trials. NEJM 2007;357:2189-2194.

Finally, if authors desire more detailed guidance on appropriate methods for analyzing study outcomes, then they can visit the Web sites of other biomedical journals. An excellent example is the Web site of Annals of Internal Medicine (http://www.annals.org/shared/author_info.html).

Updated March 2012