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Manuscript Submission
Manuscripts should be submitted via our online submission and review system. Print mail address and telephone and fax numbers of the corresponding author also should be included on the title page of the manuscript. Manuscripts submitted through our online system should not also be submitted by mail or fax. Signed authorship forms should be sent by regular mail. See Manuscript Checklist and details in these Instructions for additional requirements.
Editorial Office Contact Information
Paul A. Levine, MD, Archives of Otolaryngology—Head & Neck Surgery, 183 Tuckahoe Farm Ln, Charlottesville, VA 22901; telephone (434) 960-9202 or -9203; fax (434) 973-3454 (archoto{at}jama-archives.org).
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Categories of Articles
Original Articles. Original articles are concise (1) reports of clinical data, (2) reports of basic science data, or (3) reviews, including meta-analyses, that represent advanced information and a new contribution to biomedical literature as determined by the Archives editorial staff. Original Articles require structured abstracts as detailed under “Abstract.” For manuscripts reporting the results of randomized controlled trials, the CONSORT Checklist should be completed and submitted with the manuscript. Text should not exceed 12 double-spaced pages, 25 references, and a maximum of 6 to 8 figures/tables.
Clinical Notes/Case Reports. A case report1 should be concise and focused on one topic that results in final publication of not more than 2 journal pages, including references. As best as possible, the title should state the compelling point that draws the reader’s attention. In lieu of a structured abstract, the first 150 words will explicitly identify the compelling point of the report. These reports will describe a new disease state (with diagnostic documentation, including pathologic findings), identification of a new complication from a treatment or procedure, a new diagnostic technique, or a new technology transferred from one field to another. The case report should not be simply the report of an old disease in a new site solely because it has not been reported in the medical literature, unless there is a diagnostic point to distinguish it from other diseases. If the report provides a new treatment option, the disease should be of such rarity that it is unlikely that a series could be developed that would be amenable to standard investigational analysis. Case reports may also be based on seminal observations that provide an understanding of the mechanism of disease, particularly when the pathophysiology involves a rare and not easily retested event. Text should not exceed 6 double-spaced pages, 15 references, and a maximum of 4 figures/tables.
Clinical Problem Solving: Radiology and Pathology. Residents and fellows in otolaryngology and radiology are invited to submit quiz cases for this section and to write letters to the Archives commenting on cases presented. Quiz cases should be set up in the established format. It is suggested that authors consult previously published quiz cases for examples when preparing a submission. Text should not exceed 5 double-spaced pages and 10 references. No more than 4 figures are allowed and there can be no multiple parts to the figure. There are no figure legends in this section.
Clinical Challenges in Otolaryngology. This series is for invited manuscripts only; however, the Editor does welcome suggestions of topics for the monthly series. The author’s charge is to present a fair and balanced reflection of the good-quality information in the recent medical literature. The format is (1) Hypothesis: the controversial or puzzling statement; (2) Pro: a summary of current knowledge supporting this statement; (3) Con: a summary of current knowledge refuting this statement; (4) Bottom Line: your opinion of the truth or fallacy (or partial truth/fallacy) of the original hypothetical statement; and (5) References: the most relevant only, 10 or fewer. Also, list the key words used in your search so others can duplicate it if they wish. This review should be concise. Text should not exceed 8 to 10 double-spaced pages. The author should enclose a self-photograph to be published along with the article. When this review is published, it will appear along with a short clinical commentary by 1 or 2 other otolaryngologists generally regarded as experts in this area. While the review is intended as straightforward information, these commentaries will reflect the personal experience of the clinicians.
Reflections. This section features an essay of 1 journal page designed to relate those personal experiences in medicine that have no scientific or statistical basis. All submissions to Reflections must be previously unpublished. Any references to individuals mentioned by name must be accompanied by a signed release from the individual or from the individual’s family, if the person is deceased. Text should not exceed 3 double-spaced pages.
Letters to the Editor. Letters discussing a recent Archives article should not exceed 400 words of text and 5 references. Research Letters reporting original research, including case series or case reports, also are welcome and should not exceed 600 words of text and 6 references.
Cover Photographs. Submissions must be formatted horizontally. They can be black and white or color and at least 3.5 × 5 inches but no larger than 8 × 10 inches. If you wish to submit a digital photo, please see the Technical Requirements for Figures guidelines. Due to legal concerns, no recognizable people should appear in the picture. Please include details about where the picture was taken, how you happened to be there, and anything else you think is interesting about the image. We need the photographer’s complete name, highest academic degree, city and state of residence, and a statement explaining how the photographer is affiliated with the journal. If you would like your photo returned, please enclose a self-addressed, stamped envelope. Cover photos will be chosen at the discretion of the Archives editorial staff.
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Editorial Policies for Authors
Authorship Criteria and Contributions. Designate a corresponding author and provide a complete address, telephone number, fax number, and e-mail address. Authors are required to identify their contributions to the work described in the manuscript. Please mail or fax the authorship form with statements on (1) authorship responsibility, criteria, and contributions, (2) data access and responsibility (if the manuscript contains original data, this statement must be signed by at least 1 author who is independent of any commercial funder, eg, the principal investigator; for industry-sponsored studies, the data analysis should be conducted by statisticians in an academic center, rather than only by statisticians employed by the company sponsoring the research), (3) financial disclosure, and (4) either copyright transfer or federal employment. (5) The corresponding author must sign the acknowledgment statement.2 See the Authorship Form.
Acknowledgments. Authors are responsible for obtaining written permission from all persons named in an acknowledgment, if applicable.3 The corresponding author must sign the acknowledgment statement of the required form.
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 described in these Instructions. A group must designate at least 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, in which case the other group members are not authors, but may be listed in an acknowledgment.4
Conflict of Interest. A conflict of interest may exist when an author (or the author’s institution or employer) has financial or personal relationships that could inappropriately 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 their cover letter and on the financial disclosure form or in an attachment to the form. Authors without relevant financial interests in the manuscript should indicate no such interest.
Authors are required to report detailed information regarding all financial and material support for the research and work, including but not limited to grant support, funding sources, and provision of equipment and supplies. Each author is also required to sign and submit the following financial disclosure statement: “I certify that all my affiliations with or financial involvement, within the past 5 years and foreseeable future (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, royalties) with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript are completely disclosed.”
Authors are expected to provide detailed information about any relevant financial interests or financial conflicts within the past 5 years and for the foreseeable future, particularly those present at the time the research was conducted and up to the time of publication, as well as other financial interests, such as relevant filed or pending patents or patent applications in preparation, that represent potential future financial gain. Although many universities and other institutions and organizations have established policies and thresholds for reporting financial interests and other conflicts of interest, Archives of Otolaryngology—Head & Neck Surgery requires complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value. If authors are uncertain about what might constitute a potential financial conflict of interest, they should err on the side of full disclosure and should contact the editorial office if they have questions or concerns. In addition, authors who have no relevant financial interests are now asked to provide a statement indicating that they have no financial interests related to the material in the manuscript.
This information is for the editorial office and is not shared with peer reviewers. However, for all accepted manuscripts, authors’ disclosure of relevant financial interests and declarations of no relevant financial interests will be published. Decisions about whether financial information provided by authors should be published, and thereby disclosed to readers, are usually straightforward. Although editors are willing to discuss disclosure of specific financial information with authors, the Archives of Otolaryngology—Head & Neck Surgery’s policy is one of complete disclosure of all relevant financial interests.
This policy applies to all manuscript submissions, including letters to the editor.
Funding/Support and Role of Sponsor. All financial and material support for the research and the work should be clearly and completely identified in an acknowledgment. The 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; and preparation, review, or approval of the manuscript.
Data Access and Responsibility. For reports containing original data, at least 1 author who is independent of any commercial funder (eg, the principal investigator) should indicate that he or she 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.5 For industry-sponsored studies, the data analysis should be conducted by statisticians in an academic center, rather than only by statisticians employed by the company sponsoring the research.
Prior Publication or Duplicate Submission. Manuscripts are considered with the understanding that they have not been published previously in print or electronic format and are not under consideration by another publication or electronic medium.
Reporting Race/Ethnicity. If race or ethnicity is reported, indicate who classified the individuals as to race/ethnicity and whether the options were defined by the investigator or by the participant. Explain why race or ethnicity was assessed in the study.6
Informed Consent. For experimental investigations of human subjects, state in the “Methods” section of the manuscript that the appropriate institutional review board approved the project. For those investigators who do not have formal ethics review committees (institutional or regional), the principles outlined in the Declaration of Helsinki should be followed.7 Specify in the “Methods” section the manner in which consent was obtained from all human subjects.
Case Descriptions and Photographs. Include a signed statement of consent to publish (in print and online) all case descriptions and photographs from all patients (parents or legal guardians for minors) who can be identified in such written descriptions, photographs, or pedigrees. Please do not send masked photographs of patients. (See Patient Consent Form.)
Animal Experimentation. For experimental investigations of animal subjects, specify in the “Methods” section of the manuscript what animal-handling protocols were followed, eg, “Institutional guidelines regarding animal experimentation were followed.” For those investigators who do not have formal ethics review committees (institutional or regional), the principles outlined in the Declaration of Helsinki should be followed.7
Embargo Policy. Information regarding the content and publication date of accepted manuscripts is confidential. Information contained in or about accepted manuscripts cannot appear in print, radio, television, or in electronic form or be released to the media until 3 pm CST on the third Monday of the month.
Unauthorized Use. Accepted manuscripts become the permanent property of the AMA and may not be published elsewhere without written permission from the AMA.
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Editorial Review and Publication
Editorial Peer Review. Reviews and decisions on manuscripts in which the editor or one of the associate editors is a coauthor are managed independently by an associate editor from another institution, in conjunction with a member of the editorial board.
Editing. Accepted manuscripts are copyedited according to AMA style and returned to the author for approval. Authors are responsible for all statements made in their work, including changes made by the manuscript editor and authorized by the corresponding author.
Reprints. Reprints may be ordered when the edited typescript is sent for approval to the corresponding author (download Reprint Order Form). Reprints are shipped 3 weeks after publication. AMA does not charge a permission fee to authors who wish to use their articles or parts thereof in other books or journals. However, an author must obtain permission from AMA, as the copyright holder, for such use. To do so, send written request to Rhonda Bailey Brown, Department of Licensing and Permissions, AMA, 515 N State St, Chicago, IL 60610; fax: (312) 464-5835 (permissions{at}ama-assn.org). In the permission you receive, the proper credit line will be indicated.
e-Prints. Corresponding authors who provide an e-mail address for publication will receive an electronic link that provides 25 free online accesses to the PDF view of their article.
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Manuscript Checklist
- 1. Include electronic file of manuscript.
- 2. On the title page, designate a corresponding author and provide a complete address, telephone and fax numbers, and e-mail address.
- 3. On the title page, include a word count for text only, exclusive of title, abstract, references, tables, and figure legends.
- 4. Provide an abstract that conforms with the required abstract format, if applicable.
- 5. Double-space manuscript using 1-inch margins and leaving right margins unjustified. Do not use line numbering.
- 6. Check all references for accuracy and completeness. Put references in proper format in numerical order, making sure each is cited in sequence in text.
- 7. Include statements signed by each author on authorship responsibility, criteria and contributions; data access and responsibility (if applicable); financial disclosure; and copyright or federal employment.
- 8. Indicate specific contributions from each author (see Authorship Form).
- 9. Include acknowledgment statement signed by the corresponding author.
- 10. Include research or project support/funding in an acknowledgment.
- 11. Include written permission from each individual identified as a source for personal communication or unpublished data.
- 12. Include written permission from publishers (or other copyright owner) to reproduce or adapt previously published text, figures, and tables in print and online, and licensed versions of the Archives of Otolaryngology—Head & Neck Surgery. See Permission to Reproduce Copyright-Protected Material Form.
- 13. Include informed consent forms for identifiable patient descriptions, photographs, and pedigrees. See Patient Consent Form.
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Manuscript Preparation
Manuscripts should be prepared in accordance with the AMA Manual of Style8 and/or the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals.”9
- • Manuscripts submitted via the online system should not also be submitted by mail.
- • If a submission is accepted for publication, we will require slides or high-quality glossies of all figures (computer-generated graphics produced by high-quality laser printers are acceptable for black-and-white line art only).
- • Use only 10- or 12-point font size.
- • Double-space throughout using 1-inch margins, including title page, abstract, text, acknowledgments, references, figure legends, and tables. Do not use line numbering.
- • Titles should not exceed 75 characters, including punctuation and spacing. Avoid abbreviations in the title, abstract, and text.
Title Page (page 1 of manuscript). Give full names, highest academic degrees, and institutional affiliations of all authors. (If an author’s affiliation has changed since the work was done, list the new affiliation as well.) Designate a corresponding author and include a complete mailing address, telephone number, fax number, and e-mail address. Specify the address to which requests for reprints should be sent. If the manuscript was presented at a meeting, please specify the name of the meeting, the city where it was held, and the exact date on which the paper was read or the poster was presented. Also include on the title page a word count for the text only, exclusive of the title, abstract, references, tables, and figure legends.
Abstract (page 2 of manuscript). Include a structured abstract of no more than 250 words for reports of original data from clinical or basic science investigations and reviews (including meta-analyses).10 (See Instructions for Preparing Structured Abstracts.)
Units of Measure. Laboratory values are expressed using conventional units of measure, with relevant Système International (SI) conversion factors expressed secondarily (in parentheses) only at first mention. Articles that contain numerous conversion factors may list them together in a paragraph at the end of the “Methods” section. In tables and figures, a conversion factor to SI units should be provided in a footnote or legend. The metric system is preferred for the expression of length, area, mass, and volume. A Conversion Table is available on the Web site for the AMA Manual of Style.
Gene Names and Accession Numbers. Authors describing genes or related structures in a manuscript should include the names and accession numbers provided by the US National Center for Biotechnology Information (NCBI) or the HUGO Gene Nomenclature Committee.
Drug Names. Use generic names of drugs, unless the specific trade name of a drug used is directly relevant to the discussion.
Reproduced Materials. Reprinted tables and figures are discouraged. Original material should be provided, except under extraordinary circumstances. Acknowledge all illustrations and tables reprinted from other publications and submit written permission to reproduce (in print and online and in all licensed versions) from the original publishers. (See Permission to Reproduce Copyright-Protected Material Form.)
References. Number references in the order they are mentioned in the text; do not alphabetize. In text, tables, and legends, identify references with superscript arabic numerals. In listing references, follow AMA style, abbreviating names of journals according to Index Medicus. List all authors and/or editors up to 6; if more than 6, list the first 3 and “et al.” The reference numbers in the reference list should be keystroked. Please do not use a word processing program to generate the reference numbers, using such features as automatic footnotes or endnotes.
Web References. Please keep a print copy of any reference to Web-only information. If the URL changes or disappears, interested readers may contact the corresponding author for a copy of the information.
Authors are responsible for the accuracy and completeness of their references and for correct text citation.
Tables. Title all tables and number them in order of their citation in text. If a table must be continued, repeat the title on a second sheet, followed by (“cont”). Make certain each item in the table is in its own table cell. Do not use paragraph returns (to start new rows) or tabs (to start new columns) to format the table. See Instructions for Table Creation.
Figures. Please refer to the instructions in Technical Requirements for Figures for guidelines at submission and acceptance. Each figure must be submitted in a separate file. Figures should be submitted as high-resolution TIF or JPG files. Submit your photographic images at 5 inches (13 cm) wide at 300 pixels per inch (120 pixels per centimeter), minimum. This applies to each part for multipart figures. Save them as TIF (with LZW compression), JPG (with “maximum quality” setting), or PSD (native Adobe Photoshop format). Please do not add arrowheads, “a,” “b,” asterisks, etc directly to the file that contains the single figure. A separate composite figure in PowerPoint may be submitted to show the location of arrows, asterisks, etc.
Digitally enhanced images (eg, computed tomographic-magnetic resonance imaging scans, blots, photographs, photomicrographs, ultrasound images, x-ray films) must be clearly identified in the figure legends as electronically enhanced or manipulated. If your manuscript is accepted, you will be asked to provide 3 clearly labeled copies of the enhanced images and 3 copies of the original images.
Digital Art Submissions. RGB color submissions are preferred. Calibrated color proofs should be submitted with color digital files, if possible. The canvas size of continuous tone images should be at least 5 inches wide (depth not important) with an image resolution of at least 350 ppi. Line art images should have a minimum resolution of at least 1270 ppi. Formats acceptable are EPS, TIF, and JPG. (See Technical Requirements for Figures.)
Legends. Legends (maximum 40 words) should be typed double-spaced, on a separate page from the text. Indicate magnification and stains used for photomicrographs. Include specific postoperative intervals where applicable.
Videos. For editorial and peer review of an initial submission, submit videos in .mov, .wmv, .mpg, .mpeg, .mp4, or .avi file format. Individual videos should be less than 5 minutes long. Video dimensions should be a minimum of 320 pixels wide by 240 pixels deep. To facilitate uploading and reviewing, each video should not exceed 10 MB. Verify that all videos are viewable in QuickTime or Windows Media Player before submission.
For each video, provide a citation in the appropriate place in the manuscript text and include a title (a brief phrase, preferably no longer than 10-15 words) and a caption at the end of the manuscript. In the video caption, specify the video file format and briefly describe the content of the video. Also, enter the same title and caption in the designated fields on the Web-based manuscript submission system when uploading each video. If multiple video files are submitted, number them in the order in which they should be viewed. If a video is accepted for publication, the video title and caption will be included on the Web page that contains the link to the video.
Note: If the manuscript and accompanying video(s) are accepted for publication, all video files will be placed into a journal video frame and may be edited by the journal staff according to journal style. The journal staff may contact you to request the original full-size video without text or labels to be sent by e-mail, FTP, or CD/DVD.
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Instructions for Preparing Structured Abstracts*
All manuscripts that are (1) reports of clinical data, (2) reports of basic science data, or (3) reviews, including meta-analyses, should be submitted with structured abstracts as described below.
To permit quick and selective scanning and allow more information to be conveyed per unit of space, the headings outlined below should be included in the abstract. For brevity, parts of the abstract can be written in phrases rather than complete sentences. (For example: “2. Design. Double-blind randomized trial,” rather than “2. Design. The study was conducted as a double-blind, randomized trial.”)
*Adapted from Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Ann Intern Med. 1990;113(1):69-76.
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Reports of Clinical Data
Authors submitting manuscripts reporting clinical data should prepare an abstract of no more than 250 words under the following headings: Objective, Design, Setting, Patients (or Other Participants), Interventions (if any), Main Outcome Measures, Results, and Conclusions. The content following each heading should be as follows:
- 1. Objective. The abstract should begin with a clear statement of the precise objective or question addressed in the report. 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.
- 2. Design. The basic design of the study should be described. The duration of follow-up, if any, should be stated. As many of the following terms as apply should be used.
- A. Intervention studies: randomized controlled trial; nonrandomized controlled trial; double-blind; placebo-controlled; crossover trial; before-after trial.
- B. For studies of screening and diagnostic tests: criterion standard (that is, a widely accepted standard with which a new or alternative test is being compared; this term is preferred to “gold standard”); blinded or masked comparison.
- C. For studies of prognosis: inception cohort (subjects assembled at a similar and early time in the course of the disorder and followed thereafter); cohort (subjects followed forward in time, but not necessarily from a common starting point); validation cohort or validation sample if the study involves the modeling of clinical predictions.
- D. For studies of causation: randomized controlled trial; cohort; case-control; survey (preferred to “cross-sectional study”).
- E. For descriptions of the clinical features of medical disorders: survey; case series.
- F. For studies that include a formal economic evaluation: cost-effectiveness analysis; cost-utility analysis; cost-benefit analysis. For new analyses of existing data sets, the data set should be named and the basic study design disclosed.
- 3. Setting. To assist readers to determine the applicability of the report to their own clinical circumstances, the study setting(s) should be described. Of particular importance is whether the setting is the general community, a primary care or referral center, private or institutional practice, ambulatory or hospitalized care.
- 4. Patients or Other Participants. The clinical disorders, important eligibility criteria, and key sociodemographic features of patients should be stated. The numbers of participants and how they were selected should be provided (see below), including the number of otherwise eligible subjects who were approached but refused. 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. In intervention studies, the number of patients withdrawn for adverse effects should be given. For selection procedures, these terms should be used, if appropriate: random sample (where “random” refers to a formal, randomized selection in which all eligible subjects have a fixed and usually equal chance of selection); population-based sample; referred sample; consecutive sample; volunteer sample; convenience sample. These terms assist the reader to determine an important element of the generalizability of the study. They also supplement (rather than duplicate) the terms used by professional indexers when articles are entered into computerized databases.
- 5. Intervention(s). The essential features of any interventions should be described, including their method and duration of administration. The intervention should be named by its most common clinical name (for example, the generic term “chlorthalidone”). Common synonyms should be given as well to facilitate electronic text word searching. This would include the brand name of a drug if a specific product was studied.
- 6. Main Outcome Measure(s). The primary study outcome measurement(s) should be indicated as planned before data collection began. If the paper does not emphasize the main planned outcomes of a study, this fact should be stated and the reason indicated. If the hypothesis being reported was formulated during or after data collection, this information should be clearly stated.
- 7. Results. The main results of the study should be given. Measurements that require explanation for the expected audience of the manuscript should be defined. Important measurements not included in the presentation of results should be declared. As relevant, it should be indicated whether observers were blinded to patient groupings, particularly for subjective measurements. Due to the current limitations of retrieval from electronic databases, results must be given in narrative or point form rather than tabular form if the abstract is to appear in computerized literature services such as MEDLINE. If possible, the results should be accompanied by confidence intervals (for example, 95%) and the exact level of statistical significance. For comparative studies, confidence intervals should relate to the differences between groups. For nonsignificant differences for the major study outcome measure(s), the clinically important difference sought should be stated and the confidence interval for the difference between the groups should be given. When risk changes or effect sizes are given, absolute values should be indicated so that the reader can determine the absolute as well as relative impact of the finding. Approaches such as “number needed to treat” to achieve a unit of benefit are encouraged when appropriate; reporting of relative differences alone is usually inappropriate. If appropriate, studies of screening and diagnostic tests should use the terms “sensitivity,” “specificity,” and “likelihood ratio.” If predictive values or accuracy is given, prevalence or pretest likelihood should be given as well. No data should be reported in the abstract that do not appear in the rest of the manuscript.
- 8. Conclusions. Only those conclusions of the study that are directly supported by the evidence reported should be given, along with their clinical application (avoiding speculation and overgeneralization), and indicating whether additional study is required before the information should be used in usual clinical settings. Equal emphasis must be given to positive and negative findings of equal scientific merit.
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Reports of Basic Science
Authors submitting manuscripts reporting basic science data should prepare an abstract of no more than 250 words under the following headings: Objective, Design, Subjects, Interventions (if any), Results, and Conclusions. The content following each heading should be as follows:
- 1. Objective. The abstract should begin with a clear statement of the precise objective or question addressed in the report. If more than one 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.
- 2. Design. The basic design of the study should be described. The duration of follow-up, if any, should be stated. As many of the following terms as apply should be used.
- A. Intervention studies: randomized controlled trial; nonrandomized controlled trial; double-blind; placebo-controlled; crossover trial; before-after trial.
- B. For studies of screening and diagnostic tests: criterion standard; blinded or masked comparison.
- C. For studies of causation: randomized controlled trial; cohort; case-control; survey (preferred to “cross-sectional study”).
- D. For descriptions of biologic characteristics: anatomic; audiologic; physiologic; genetic analysis; etc.
- 3. Subjects. The numbers of subjects and how they were selected should be provided. If matching is used for comparison groups, characteristics that are matched should be specified. In intervention studies, the number of subjects withdrawn for adverse effects should be given.
- 4. Intervention(s). The essential features of any interventions should be described, including their method and duration of administration.
- 5. Results. The main results of the study should be given. Measurements that require explanation for the expected audience of the manuscript should be defined. Important measurements not included in the presentation of results should be declared. As relevant, it should be indicated whether observers were blinded to groupings, particularly for subjective measurements. Due to the current limitations of retrieval from electronic databases, results must be given in narrative or point form rather than tabular form if the abstract is to appear in computerized literature services such as MEDLINE. No data should be reported in the abstracts that do not appear in the rest of the manuscript. If more than one outcome measure is addressed, list results separately.
- 6. Conclusions. Only those conclusions of the study that are directly supported by the evidence reported should be given, along with their clinical application (avoiding speculation and overgeneralization), and indicating whether additional study is required before the information should be used in usual clinical settings. Equal emphasis must be given to positive and negative findings of equal scientific merit.
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Review Manuscripts (Including Meta-analyses)
Authors submitting review manuscripts and reports of the results of meta-analyses should prepare an abstract of no more than 250 words under the following headings: Objective, Data Sources, Study Selection, Data Extraction, Data Synthesis, and Conclusions. The content following each heading should be as follows:
- 1. Objective. The abstract should begin with a precise statement of the primary objective of the review. The focus of this statement should be guided by whether the review emphasizes factors such as cause, diagnosis, prognosis, therapy, or prevention. It should include information about the specific population, intervention, exposure, and test or outcome that is being reviewed.
- 2. Data Sources. A succinct summary of data sources should be given, including any time restrictions. Potential sources include experts or research institutions active in the field, computerized databases and published indexes, registries, abstract booklets, conference proceedings, references identified from bibliographies of pertinent articles and books, and companies or manufacturers of tests or agents being reviewed. If a bibliographic database is used, the exact indexing terms used for article retrieval should be stated, including any constraints (for example, English language or human subjects).
- 3. Study Selection. The abstract should describe the 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 methodologic designs. The method used to apply these criteria should be specified (for example, blind review, consensus, multiple reviewers). The proportion of initially identified studies that met selection criteria should be stated.
- 4. Data Extraction. Guidelines used for abstracting data and assessing data quality and validity (such as criteria for causal inference) should be described. The method by which the guidelines were applied should be stated (for example, independent extraction by multiple observers).
- 5. Data Synthesis. The main results of the review, whether qualitative or quantitative, should be stated. Methods used to obtain these results should be outlined. Meta-analyses should state the major outcomes that were pooled and include odds ratios or effect sizes and, if possible, sensitivity analyses. Numerical results should be accompanied by confidence intervals, if applicable, and exact levels of statistical significance. Evaluations of screening and diagnostic tests should address issues of sensitivity, specificity, likelihood ratios, receiver operating characteristic curves, and predictive values. Assessments of prognosis could include summarizations of 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.
- 6. Conclusions. The conclusions and their applications should be clearly stated, limiting generalization to the domain of the review. The need for new studies may be suggested.
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Registration of Clinical Trials
In concert with the International Committee of Medical Journal Editors (ICMJE), Archives of Otolaryngology—Head & Neck Surgery will require, as a condition of consideration for publication, registration of all trials in a public trials registry (http://www.clinicaltrials.gov, http://www.anzctr.org.au, http://www.umin.ac.jp/ctr, http://www.isrctn.com, http://www.trialregister.nl/trialreg/index.asp).9,11 Trials must be registered at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after July 1, 2005. For trials that began enrollment before this date, registration will be required by September 1, 2005, before considering the trial for publication. For this purpose, the ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (eg, phase 1 trials), are exempt.
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REFERENCES
- 1. Richtsmeier WJ. Case report. Arch Otolaryngol Head Neck Surg. 1993;119(9):926.MEDLINE
- 2. Lundberg GD, Flanagin A. New requirements for authors: signed statements of authorship responsibility and financial disclosure. JAMA. 1989;262(14):2003-2004.MEDLINE
- 3. Glass RM. New information for authors and readers: group authorship, acknowledgments, and rejected manuscripts [published correction appears in JAMA. 1993;269(1):48]. JAMA. 1992;268(1):99.MEDLINE
- 4. Flanagin A, Fontanarosa PB, DeAngelis CD. Authorship for research groups. JAMA. 2002;288(24):3166-3168. FULL TEXT | MEDLINE
- 5. DeAngelis CD, Fontanarosa PB, Flanagin A. Reporting financial conflicts of interest and relationships between investigators and research sponsors. JAMA. 2001;286(1):89-91. FULL TEXT | MEDLINE
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