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American Journal of Ophthalmology

American Journal of Ophthalmology
ISSN: 0002-9394
Imprint: ELSEVIER

Statistics
Impact Factor: 3.102
Issues per year: 12

Guide for Authors



MISSION STATEMENT

The American Journal of Ophthalmology (AJO) is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists. The manuscripts describe clinical investigations, clinical observations, and clinically relevant laboratory investigations. Published monthly since 1884, the full text of the AJO and supplementary material are also presented on the Internet at AJO.com.

The AJO publishes Full-Length Articles, Perspectives, Editorials, Correspondence, Book Reports and Announcements.

Manuscripts are accepted with the understanding that they have not been and will not be published elsewhere substantially in any format, and that there are no ethical concerns with the content or data collection. Authors may be requested to produce the data upon which the manuscript is based and to answer expeditiously any questions about the manuscript or its authors. See AJO policies on redundant publication and access to data.

Table of Contents

1. ONLINE MANUSCRIPT SUBMISSION
2. MANUSCRIPT REVIEW AND SELECTION
3. COPYRIGHT TRANSFER PREPARATION
4. PERMISSIONS
5. COVER LETTER
6. GENERAL MANUSCRIPT PREPARATION GUIDELINES
A. Style
B. Reporting Visual Acuity
C. Abbreviations
D. Statistics
E. Informed Consent
F. Use of Animals in Biomedical Research
7. FULL-LENGTH ARTICLES
A. Title Page
B. Abstract
C. Text
D. Acknowledgments/Disclosure
a. Funding/Support (including none)
b. Financial Disclosures (including none)
c. Contributions to Authors in each of these areas
d. Statement about Conformity with Author Information
e. Other Acknowledgment
E. Appendix
F. References
G. Figure Captions
H. Tables
I. Figures
a. AJO Requirements for Publication Quality Digital Figures
b. Other General Figure Guidelines
8. RANDOMIZED CONTROLLED TRIALS
9. PERSPECTIVES
10. EDITORIALS
11. CORRESPONDENCE
12. ANNOUNCEMENTS
13. BOOK REVIEWS
14. OBITUARIES
15. CHECKLIST FOR AJO SUBMISSION
16. REVISED MANUSCRIPTS
17. ACCEPTED MANUSCRIPTS/SUPPLEMENTAL MATERIAL
18. PUBLICATION PROCESS
19. APPEALS PROCESS
20. AJO ON THE INTERNET
21. AJO POLICIES
A. Rejection by Previous Journal
B. Duplicate Publication
C. Statements of Priority
D. Multicenter Studies
E. Suggestions for Research Presenters at Scientific Meetings Prior to Publication
F. Secondary Publication
G. Defining Authorship Contributions
H. Conflict of Interest in Peer-review Process and Disclosure
Financial and Non-financial Conflicts
I. Corrections and Retractions
J. Confidentiality
K. Conduct and Communication of Clinical Trials
L. AJO Access to Scientific Data
M. Reporting New Microbial Organisms in Ophthalmic Infections
N. Cancer Classification Scheme
O. Ocular Trauma Terminology
P. Clinical Trials Registration
22. FORMS
A. Author Disclosure Statement
B. Contributions of Authors and Sponsors Form
C. Consort Statement (External link http://www.consort-statement.org )
D. Consent Form for Identifiable Photographs
23. GLOSSARY OF STUDY DESIGN



1. ONLINE MANUSCRIPT SUBMISSION

The AJO accepts online submission of manuscripts through Editorial Manager. When a manuscript is submitted online, authors, selected reviewers, editors, and the AJO office can track the progression of the manuscript until a final disposition is made.

Editorial Manager can be accessed at www.EditorialManager.com/AJO; alternatively, links to the online submission system are available at AJO.com. On the Editorial Manager front page, click the "Register" link to input your demographics and set up your account. After your registration is complete, a notice will be sent to your e-mail address indicating your user ID and your password. Use this information to log in to Editorial Manager as an author by choosing the "Login" link on the toolbar and select "Submit New Manuscript." Follow the prompts to complete your submission according to the specifications below. Contact the Editorial Office if you have any problems or questions. You may change your ID and password to something more familiar to you, or update any personal information including your e-mail address, at any time by clicking on the "Update My Information" icon at the top of your screen. Abstract, Disclosure, Contributions of Authors form, Manuscript, and Figures must be prepared as SEPARATE files; the system requires that each of these files be uploaded separately and blocks incomplete manuscripts from being submitted to the office. Although Editorial Manager presently accepts many file formats for the peer-review process, authors should use only those formats that are acceptable to the publisher, Elsevier, in order to ensure proper publication in the print issues. Please refer to the following individual sections for specific file requirements for text, tables, and figures. Each uploaded file must have a corresponding file extension (such as .doc, .tif). Adherence to the guidelines is essential, and faulty manuscripts will be returned to authors for correction before peer-review. Other queries may be sent to:

Thomas J. Liesegang, MD, Editor-in-Chief
American Journal of Ophthalmology
Mayo Clinic
4500 San Pablo Road
Jacksonville, FL 32224-1865
or to Liesegang.Thomas@MAYO.edu

For comments and questions, you may contact the Editorial Office of the AJO by telephone: (904) 953-2555; fax: (904) 953-2551; or e-mail: AJO@MAYO.edu.

If the AJO office uploads a manuscript on behalf of an author, the Corresponding Author will receive an e-mail receipt of the manuscript and related notices regarding the manuscript. Once a manuscript has been uploaded into the system, status updates are available by logging into Corresponding Author's account.

2. MANUSCRIPT REVIEW AND SELECTION

Full-Length Articles, Editorials, and Perspectives are peer-reviewed.

After an initial review of the manuscript, the Editor-in-Chief selects an Executive Editor from the Editorial Board who is an expert in the field and who will be responsible for guiding the manuscript through the review process. The Executive Editor then selects several outside reviewers to ensure that at least two reviews are completed. The AJO does not reveal the identity of its reviewers.

Once these reviews are completed, the Executive Editor critiques and synthesizes the comments of the reviewers, and provides additional Executive Editor's comments to the Editor-in-Chief. The Editor-in-Chief reviews the manuscript together with all comments and makes the publication decision, which is then e-mailed to the Corresponding Author, along with consolidated comments of the reviewers of the manuscript. Because of space constraints in the printed version, only about 20% of submitted Full-Length Articles are accepted.

3. COPYRIGHT TRANSFER PREPARATION

After acceptance of a manuscript by the Editorial Board, the publisher, Elsevier, will send to the Corresponding Author the forms to complete the transfer of copyright to Elsevier. Do not send copyright transfer forms to the AJO office. Elsevier conforms to the National Institutes of Health and other governmental open access policies.

4. PERMISSIONS

If the authors plan to use figures, photographs, or tables from other publications, these items must be accompanied by written permission from the copyright holder to reprint such items in AJO. Copies of any permission to report information about identifiable individuals, or to name individuals for their contributions must accompany the manuscript. Authors may use their own forms or request specific forms provided by the Elsevier Rights Department. These forms must be sent to the Editorial Office either with the electronic submission (by scanning the forms) or by fax. A manuscript cannot be accepted until all permissions are confirmed.

All requests to reproduce or make available anything from the AJO—in whole or in part, in electronic or in any other format including translation—must be sent to:

E-mail: healthpermissions@elsevier.com

Requests may also be completed online at: www.elsevier.com/permissions

5. COVER LETTER

Manuscripts must be accompanied by a cover letter that should include information on prior or duplicate publication or submission, as well as the originality of the manuscript and any other information that the authors want to convey to the Editor-in-Chief. The authors should indicate whether the manuscript was previously rejected or evaluated in any form by another journal, and they should describe specifically how they have improved the manuscript.

The principal investigator or the Corresponding Author of a manuscript containing original data must confirm in the cover letter 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 as well as the decision to submit for publication." Cover letters for revised manuscripts must answer, point by point, any concerns noted by reviewers.

6. GENERAL MANUSCRIPT PREPARATION GUIDELINES

Manuscripts (including title page, abstract, text, references, figure captions, and tables) should be single-spaced on 21.5 x 28 cm (8.5 x 11 in.) paper (or digital format). Margins of at least 2.5 cm (1 in.) should be used, and the first line of each paragraph should be indented. If the author mails the digital version of the manuscript to the AJO office, it must be prepared using Microsoft Word or WordPerfect and saved on a CD-ROM disk. All digital files must have a file extension. The right margin should be ragged, not justified.

A. STYLE
Follow guidelines of style, terminology, measurement, and quantitation as set forth in the American Medical Association Manual of Style (10th ed. Oxford University Press, NY, 2007). Arial font size 12 is recommended, as this font causes the fewest problems during conversion to PDF.
B. REPORTING VISUAL ACUITY
The AJO encourages authors to report the visual acuity in the manuscript using the same nomenclature that was used in the study, provided the data was recorded in the Snellen system (using either meters or feet), decimal fraction or logMAR systems. The same visual acuity nomenclature should be presented throughout the manuscript. A Table of Equivalent Visual Acuity Measurements will be provided for the reader in each print issue of AJO. Although standardized reporting of visual acuity would be a better option, it has not yet been accepted by all research groups. The Snellen equivalent in feet should be noted in parentheses next to each visual acuity that is not in the Snellen format, in order to aid readers in the United States.
C. ABBREVIATIONS
Restrict abbreviations to those that are widely used and understood. Avoid abbreviations that have meaning only within the context of the specific manuscript. Introduce each abbreviation in parentheses after the first use of the full term in the abstract, in the text, in the figures captions, and in the tables. Système International units and abbreviations of standard measurements, such as mm Hg, cm, and ml, are used without initial expansion.
D. STATISTICS
The AJO requests authors to ensure statistical expertise for a study that has statistical content. Statistical methods must be identified in the manuscript whenever they are used. Software programs used for statistical analyses should be identified so reviewers or readers may verify calculations. When P values are used, the actual P value (for example, P = .032) is preferred to an inequality (for example, P < .05). Reporting basic summary statistics, such as the mean and the standard error, as well as confidence limits, also helps the reader understand the conclusions of the study. Models such as analysis of variance, covariance, multiple regressions, and the like must be specified. A sample size calculation and power analysis should be included when appropriate. Authors should state the levels for alpha and beta errors and the clinically significant difference that was used to determine the power calculation. Numeric equivalents should precede all percentages, as in the following examples: "Of 80 patients, 20 (25%) had retinopathy " or "20 (25%) of 80 patients had retinopathy."
E. INFORMED CONSENT
When human subjects participate in studies or reports, the authors must state in the Acknowledgment section (see Acknowledgement section) that the study and data accumulation were carried out with approval from the appropriate Institutional Review Board (IRB), Informed Consent for the research was obtained from the patients or subjects, and, for US authors, the study is in accordance with HIPAA regulations. Alternatively, the authors can state that the IRB (name the IRB) waived the need for IRB approval; the authors, however, cannot make the decision that IRB approval was not needed. If waived, the authors must confirm that the study and data accumulation were in conformity with all country, federal, or state laws, informed consent was obtained, and the study was in adherence to the tenets of the Declaration of Helsinki. Do not use patients' names, initials, dates, or hospital numbers, especially in illustrative material. Informed Consent for research requires that the subjects agreed to participate after explanation of the nature and possible consequences of the study. This Informed Consent for Research is distinct from the simple informed consent to perform a procedure or test on a patient.
F. USE OF ANIMALS IN BIOMEDICAL RESEARCH
If animals are used in the protocol or the study, the manuscript should describe in the Acknowledgment section the animal care protocol that was followed, name the institution that sponsored the study, and identify relevant IRB approval. Biomedical research involving animals must conform to generally accepted principles of animal maintenance and care, such as those of the Association for Research in Vision and Ophthalmology (External link http://www.arvo.org/eweb/dynamicpage.aspx ).


7. FULL-LENGTH ARTICLES

Full-Length Articles are previously unpublished manuscripts directed to ophthalmologists and visual science specialists. They include clinical investigations, clinical observations, and clinically relevant laboratory investigations. Full-Length Articles should, in general, not exceed 7 to 8 single-spaced typewritten pages, including references, figure captions, and tables (approximately 4 to 5 published pages). Supplemental Material may be provided for the AJO website if a manuscript is accepted. Manuscripts should begin each component on a new page in the following order: (1) title page, (2) text, (3) acknowledgments/disclosure, (4) references, (5) figure captions, (6) tables, (7) figures, (8) contributions to authorship form, (9) disclosure form, and (10) permission forms. The abstract should be prepared and submitted as a separate document. Refer to the Checklist when submitting.

A. TITLE PAGE
The manuscript's title should be as brief as possible and no longer than 135 characters and spaces.
The title page should include:
1) The title of the article (informative and concise; avoid questions and declarative sentences).
2) The full name of each author and complete address of institutional affiliations. Academic degrees should not be provided.
3) The name, address, phone number, fax number and e-mail address of the Corresponding Author.


Once a manuscript has been submitted, the order and number of authors should not change.

The Corresponding Author will be responsible for all questions about the manuscript and for reprint requests. Only one author can be designated as Corresponding Author; the Corresponding Author need not be the first author on the manuscript. Select a Corresponding Author who will be located at the same address for an extended period in order to respond to post-publication correspondence. Corresponding authors that do not reply in an expeditious manner to all correspondence from AJO may be restricted from further submissions to the AJO.

B. ABSTRACT
Provide a structured abstract of 250 words or less with the following five headings:

Purpose: State the principal question or objective of the study and the major hypothesis tested, if any.

Design: Describe the study as retrospective or prospective. Identify the study design. Interventional studies should be listed as a randomized clinical trial, non-randomized clinical trial, interventional case series (three or more cases), or interventional case report (one or two cases). Observational studies should be listed as a case control study, cross-sectional study, cohort study, or observational case series (three or more cases). An experimental study should be listed as an animal study or laboratory investigation. A perspective, meta-analysis, or auto-designation study should be indicated, as appropriate.

Methods: Use the following subheadings under Methods as appropriate for your study or, alternatively, provide the same information in prose format:
  • Setting: Such as multicenter, institutional, or clinical practice.
  • Patient or Study Population: Including patient numbers (one or both eyes), selection procedures, inclusion/exclusion criteria, randomization procedure, and masking.
  • Intervention or Observation Procedure(s)
  • Main Outcome Measure(s)


Results: Describe the outcome and measurements, when applicable. Results should be accompanied by data with confidence intervals and the exact level of statistical significance. Results should also identify any significant limitations or qualifications of the data.

Conclusions: State the conclusions directly supported by the data and describe the clinical applications. Avoid over-generalizations. Give equal emphasis to positive and negative findings, and note whether additional study is required.

C. TEXT
Number the pages of the manuscript consecutively, beginning with the Introduction as page 1. For Full-Length Articles, the text should, in general, not exceed 8 single-spaced typewritten pages. Please use a spell-checker in addition to careful editing of the manuscript before submission. Authors should not use a line numbering system as this is automatically provided by Editorial Manager™ system.

Organize and prepare the manuscript to include the following sections:

Introduction: Describe the purpose of the study, the research rationale, and any major hypothesis that was tested. The Introduction should present the hypothesis and limit references to only the most pertinent previous publications.

Methods: The study design should be included in the Methods section of the text manuscript rather than as a separate section. The following content should be provided in the Methods section of the text as applicable with the information presented in prose format.

Include setting (multicenter, institutional, or clinical practice); patients and study population (including patient numbers, selection procedures, inclusion/exclusion criteria, randomization, and masking); intervention or observation procedure; and main outcome measure(s). Statements about IRB approval, adherence to tenets of Declaration of Helsinki, or patient consent should be included in the Acknowledgment section rather than the Methods section, as appropriate for the study. Previously published procedures should be identified by reference only unless they are uncommon to AJO readers. Provide sufficient detail to enable others to duplicate the research. Use standard chemical or nonproprietary pharmaceutical nomenclature. Identify in parentheses specific sources by brand name, company, city, state, and/or country.

Results: Describe outcomes and measurements in an objective sequence with a minimum of discussion. Tables and figures should be cited in text in sequence. Data should be accompanied by confidence intervals (usually at the 95% interval) and exact P values or other indications of statistical significance.

Discussion: Elucidate (but do not reiterate) the results, identify any statistically or clinically significant limitations or qualifications of the study, provide responses to other and contradictory literature, and state the conclusions that are directly supported by the data. Excessive generalization and undue speculation should be avoided. Give equal emphasis to positive and negative findings, state whether and what additional study is required, and conclude with the clinical applications or implications supported by the study. The conclusions should be incorporated into the end of the discussion.

Authors should avoid statements of economic benefits and costs unless their manuscript includes economic data and analyses. Avoid claiming priority (first publication) of the content unless you provide the literature search protocol used. Do not allude to work that has not been completed.

D. ACKNOWLEDGMENTS /DISCLOSURE:
The AJO requires enhanced disclosure information from the authors in a specific format. The following information should appear, in the order indicated (labeled A through E), in the Acknowledgement section of the manuscript (just prior to the References). The information will appear in the print journal. This information should not appear on the Title page of the manuscript or in the Methods section of the manuscript.
a. Funding/Support (including none): any government and non-government support must be acknowledged. (The authors are reminded that several governments require providing open access to your manuscript.)
b. Financial Disclosures: now or in the previous two years that related to any commercial companies or devices (including none); employee, consultant or advisory positions; speaker bureaus, lecture fees; grant support, equity payments; patents; advisor to investment companies; and expert witness testimony. Financial involvement with companies that directly compete with products in this manuscript must also be disclosed. Do not try to determine yourself if your financial disclosures relate to the manuscript as that is for the editors and reader to determine.
c. Contributions to Authors in each of these areas: design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. After each component, provide author initials in parentheses, SAMPLE: Contributions of Authors: Design of the study (AB, CD, EF); Conduct of the study (AB, EF, GH), etc. Each author must have a specific role in the manuscript. Overall management/supervision of a laboratory alone or a position of chairmanship alone does not constitute an authorship role. The AJO does not permit guest or honorary authorship.
d. Statement about Conformity with Author Information: Name of IRB that approved the research or provide a statement and rationale as to why the named IRB waived approval, proper informed consent for both the treatment and participation in the research, HIPAA compliance, Clinical Trials registration, number and location, and Institutional Animal Care and Use Committee guidelines. If the IRB waived the need for approval of this research, then indicate adherence to the Declaration of Helsinki and all federal or state laws in your country. Authors cannot make the decision as to whether IRB approval is needed; your IRB should make that decision and provide a waiver if they feel it does not require IRB approval.
e. Other Acknowledgments: Statisticians and medical writers or industry writers might fulfill the criteria for authorship and should be recognized in that role. Otherwise recognize statistical consultation, medical writers or industry writers in the acknowledgment. Include the name and affiliation of the individual. The AJO does not accept manuscripts that do not accurately reflect who wrote the content i.e., the AJO does not permit ghost (hidden) authors. Editorial assistants, photographers, artists, laboratory associates, and others who simply assist in preparation of a manuscript are not to be acknowledged, however valuable their service. The Editor-in-Chief will permit limited exceptions.


Because readers may infer endorsement of the data and conclusions, all persons must have given permission to be acknowledged and this must be confirmed in the cover letter.

E. APPENDIX
Appendixes should be used sparingly, but they are appropriate to provide survey forms, list the members of a study group, or complex formulas and information. Please note that Supplemental Material for the AJO website may be provided for Full-Length Articles and Perspectives at the time of acceptance.

F. REFERENCES
References should be numbered consecutively in the text and in the reference list. In the text, reference numbers are entered as superscripts. If you use an automated reference numbering software (e.g., Endnote or Reference Manager) the linkage must be turned off.

The references must be verified by the author(s) against the original documents. PubMed offers a useful reference checker at External link http://www.ncbi.nlm.nih.gov/entrez/query/static/citmatch.html . A link to each of your specific references in PubMed is provided at the time of a requested revision and therefore incorrect references are not tolerated.

References to journal articles should follow the AMA format and include:


1) Authors' surnames and initials (list 6; for more than 6 authors, list the first 3 followed by "et al.")
2) Title of Article
3) Journal name (as abbreviated in PubMed)
4) Year
5) Volume number
6) Issue number
7) Inclusive page numbers

References to books should include:
1) The author or authors
2) Chapter title (if any)
3) Editor or editors (if any)
4) Book title
5) Edition (other than the first)
6) City of publication
7) Publisher
8) Copyright year
9) Inclusive pages of the chapter or section cited

Examples are as follows:
Journal article: Robinson MR, Reed G, Csaky KG, Polis MA, Whitcup SM. Immune-recovery uveitis in patients with cytomegalovirus retinitis taking highly active antiretroviral therapy. Am J Ophthalmol 2000;130:49-56.
Journal article with organization as author: The Cardiac Society of Australia and New Zealand. Clinical exercise stress testing: safety and performance guidelines. Med J Aust 1996;164:282-284.
Book: Rootman J, Stewart B, Goldberg RA. Orbital surgery: a conceptual approach. Philadelphia: Lippincott-Raven, 1994:1-394.
Book chapter: Macsai MS, Mannis MJ, Huntley AC. Acne rosacea. In: Mannis MJ, Macsai MS, Huntley AC, editors. Eye and skin disease. Philadelphia: Lippincott-Raven, 1996:335-341.

A reference to a study that has been accepted for publication but is not yet published or reference to an Epub article should be identified as "forthcoming" rather than as "in press." The reference should name the journal or other publication in which the study will appear.

Unpublished data, such as studies in preparation or submitted for publication, posters, and unpublished abstracts the reader cannot retrieve in a literature search, are to be incorporated parenthetically in the text. The Corresponding Author is to provide authorization for use of this personal communication.

Association for Research in Vision and Ophthalmology (ARVO) and other abstract references are discouraged. If used, ARVO abstract citations should appear parenthetically within the text, not as bibliographic references, in the exact format recommended by ARVO. Citations should include: (1) name of first author, (2) "IOVS", (3) year, (4) volume number, (5) "ARVO E-Abstract", and (6) program number. Eg., (Roska BM, et al. IOVS 2002;43:ARVO E-Abstract 1415).

Personal communications should be cited parenthetically in the text, as in this example: (Evans DW, written communication, September 1, 1997). The Corresponding Author should provide authorization for use of this personal communication.

Internet references should be limited to important Full-Length articles that are not available in print or have been updated on the Internet since initial print publication. If a print reference is available, it should be used. The online reference should be listed with complete information including title and authors with the addition of the URL address and accession date. The URL address and availability must be confirmed again with any revision submission. Because Internet articles frequently are not available at a future date, the authors must make a print copy of the material they are referencing from the Internet, hold it indefinitely, and provide it to the AJO at any time in the future.
Example: International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. Available at External link http://www.icmje.org . Accessed November 12, 2006.

G. FIGURE CAPTIONS
All captions should be listed together on a Caption page preceding the Tables. Each caption should be numbered consecutively in the text, have a brief title, and contain a complete description of each figure. The brief title should generally name the disease process or study patients that are in the manuscript. The title and caption should contain enough information so that the figure can be understood independently of the manuscript text and be understood as a "stand alone". Use complete sentences for the captions except in the title. Single figures should not be numbered.

When multiple-panel figures are submitted, refer to each panel from Top left to Top right, then Bottom left to Bottom right. Do not use lettering (e.g., A, B, C, etc) on the figures.

Example. FIGURE 1. Patient 3 with staphylococcal corneal abscess. (Top left) The patient's cornea is shown preoperatively with the abscess located superior to the visual axis, (Top right) 3 days postoperatively with the corneal transplant well centered and clear, and (Bottom left) 4 months postoperatively with a crystal clear cornea. (Bottom right) The patient, 1 year postoperatively, shows smooth corneal surface with all sutures removed.

H. TABLES
Tables take up substantial space in the print journal and should be limited in number. The information in the text and tables should not be duplicative.

Tables should be numbered consecutively in Arabic numerals by order of citation in the text. Single tables should not be numbered. Each table should have a brief title so that the reader can understand what is being displayed in the table without reference to the text. Each table should be submitted on a separate page. The table number and table title should be on the same line at the top of the table. All abbreviations and comments about the table should be included in a footnote to the table.

All tables should be created in a Microsoft Word document using the table tools. Do not format tables as columns or tabs. Each table should be double-spaced. Use additional pages when a table does not fit onto one page.

Footnotes to tables are indicated by superscripted letters a, b, c, etc.

I. FIGURES
As with the manuscript, digital figures for submission must be uploaded into the Editorial Manager system. If you are unable to upload digital figures, send the digital or hard copy figures to the AJO office for uploading in preparation for peer-review.

a) AJO Requirements for Publication Quality Digital Figures:
Digital Figures should be of high quality and formatted according to the following guidelines:
Line Art/Graph Picture size: No larger than 12 MB if possible; Picture size: at least 3.5 inches wide. Scanned Resolution: 1000 dpi.
Format: EPS or TIFF
Photographs Picture size: at least 3.5 inches wide. Scanned Resolution: least 300 dpi.
Format: EPS or TIFF. Any photographs with text must be saved as a TIFF file. Text and lettering should be limited on figures and must adhere to the font and appropriate point size discussed in the general figure guidelines below.
PLEASE NOTE: Figures cannot be embedded or otherwise included in the text file. Do not submit figures as PDFs, Excel files, or PowerPoint slides. Additional instructions regarding the submission of Figures and Video Supplemental Material are available at the Elsevier Author Gateway (External link http://authors.elsevier.com/artwork ). The AJO has an Artwork Quality check performed on each figure at the time of submission of revision. The authors must confirm that the figures pass this verification system. Authors should bear in mind, however, that the AJO standards for art may exceed those of the artwork quality check tool. If digital figures cannot be submitted or do not meet the above requirements, the authors many submit one 5 x 7-inch, high-quality glossy print of each figure in black and white or in color with sharp contrasts of each figure, labeled only on the back, in a separate protected envelope. High quality slides of clinical material are also acceptable (PowerPoint content is not acceptable). The first author's last name and the number of figures enclosed should be indicated on each envelope. No printing should appear on the front of the figure, except minimal letters, arrows, or both. The back of the figure should be labeled with the figure number and the manuscript number as assigned by the AJO, as well as the first author's name and contact information. Graphs and line art should be from a high-quality printer or prepared by a graphic artist. Individual pieces or panels of a figure are not to be mounted, taped, or paper-clipped together.
b) Other General Figure Guidelines
Avoid letters and text on photographs unless absolutely necessary. Most comments can be moved to the caption. Lettering, arrows, and other symbols should be large enough to remain legible after reduction. All symbols or letters that appear on the figures should be defined in the caption. Arial font at an appropriate font size should be used for any lettering on a figure.

Figures should be cropped to show only significant details. When a patient is identifiable in a photograph, the author(s) must supply the AJO with evidence of the patient's permission to publish the photograph. (The permission must be submitted to the AJO as a scanned document through Editorial Manager.)

The authors should use color figures only when necessary. If a manuscript has been submitted and reviewed with color photos, it will be published in color unless the Editor-in-Chief elects otherwise after communication with the Corresponding Author. The Publisher requires authors to pay for color art that appears in their article. The cost for the first color figure is $650, and the cost for every subsequent color figure is $100. Authors will be billed after the article has been published for color figure(s).

The Editor-in-Chief reserves the right to withdraw a previously accepted manuscript if the author cannot produce high-quality figures in a timely manner to accompany the text.

8. RANDOMIZED CONTROLLED TRIALS

Manuscripts reporting randomized controlled trials should adhere to the requirements for Manuscript Preparation. In addition, text (which may be up to 10 single-spaced typewritten pages in length) should contain subheadings and information specified in the Consolidated Standards of Reporting Trials (CONSORT) statement. A flow diagram to illustrate the randomization procedure or procedures and numbers and the AJO Consolidated Standards of Reporting Trials (CONSORT) Statement Form must be submitted with the manuscript. Authors may decide whether this form will appear in print or only online as Supplemental Material. These requirements follow suggestions published in the Journal of the American Medical Association (JAMA). (Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT Statement. JAMA 1996;276:637-639).

9. PERSPECTIVES

Invitation-only AJO Perspectives are focused reviews of the evidence supporting the use of a current technique, procedure, therapy, or clinical approach, tempered by the experience and viewpoints of the authors(s). Perspectives should not be a review article. Perspective preparation should follow the guidelines of a Full-Length Article, including a structured abstract of 250 words or less and Table of Contents statement of 75 words or less. The Perspective should be of appropriate length but should not exceed 9 pages of single-spaced typewritten text, 35 references, and 8 figures or equivalent tables. Authors share the cost of color figure reproduction. Perspectives are subject to the standard peer-review process, which is necessary to meet the policies and standard procedures of the AJO.

Because the essence of a Perspective is selection and interpretation of the literature, the AJO expects that authors of such articles will not have any significant financial interest in a company (or its competitor) that makes a product discussed in the article.

10. EDITORIALS

Editorials provide a forum for interpretive, analytical, or reflective opinions related to manuscripts in the AJO or statements about clinical, scientific, or socioeconomic issues. The invitation-only Editorial should be objective and dispassionate, but is likely to provide alternative points of view and some bias. Editorials should not exceed 1200 words with no more than 15 references. In general, figures and tables should not be used.

Because the essence of an Editorial is selection and interpretation of the literature, the AJO expects that authors of such articles will not have any significant financial interest in a company (or its competitor) that makes a product discussed in the article. Funding and financial disclosure is required in the Acknowledgments before the references. Editorials do not have an Abstract.

11. CORRESPONDENCE

Letters about recent Articles published in the AJO should be submitted through the Editorial Manager system within 8 weeks of the Article's publication. Correspondence may correct errors, provide support or agreement, or offer different points of view and additional information.

Correspondence submitted should not exceed 500 words of text and six references. One of the references should be the Article in question. Figures and tables are generally not accepted. Correspondence is considered for publication by the Editorial Board and is subject to editing. The authors of articles discussed in the correspondence are given an opportunity to reply in an expedited fashion, adhering to the AJO policy on Responsibility of Authors. If authors do not reply to the correspondence within 14 days, this statement may appear in the AJO print issue in association with the correspondence: "The Authors failed to provide a response to the correspondence in a timely manner." Please provide a complete title page as defined above under Full-Length Article instructions.

When appropriate, an effort is made before publication to resolve any controversies between correspondents and the authors of an article.

12. ANNOUNCEMENTS

The AJO offers limited opportunities to announce national or international meetings, symposia, or workshops. Other honors or awards may also be appropriate to announce. The Editor-in-Chief makes the final decision about material to include in the Announcements section of the AJO. Announcements are presented in very brief format in the print publication, with more extensive information at www.AJO.com. Announcements should be sent in digital format by e-mail to the AJO at AJO@MAYO.edu.

13. BOOK REVIEWS

The AJO offers limited opportunity for reviews of ophthalmic books, monographs, or software. Reviews are by invitation only. Publishers or authors are invited to submit this material to the AJO Book Review Editor, Dr David Coats, at the address below:
6621 Fannin MC-CCC 640-00
Houston, TX 77030

The Book Review Editor will then forward the material to one or more of the AJO's reviewers for evaluation. The Editor-in-Chief makes the final decision as to what material will be published. The reviews are presented in very brief format in the print publication, with more extensive information available at www.AJO.com.

14. OBITUARIES

Obituaries may be offered by readers or requested by the Editor-in-Chief to commemorate the lives of remarkable individuals who are internationally renowned for their contributions to Ophthalmology. The Editor-in-Chief makes the final decision about publishing Obituaries.

15. CHECKLIST FOR AJO SUBMISSION

Below is a checklist of items required by the AJO for evaluation of a submission. These items should be included in each submission. Please be sure that you have thoroughly read the instructions for preparation and submission of your manuscript before submitting it.

• Cover Letter indicating the manuscript's category (Full-Length Article, Perspective, Editorial, Correspondence)
Author Disclosure Statement (filled out and uploaded).
Contributions of Authors and Sponsors Form (filled out and uploaded).
• Permission for figures if there is identifiable material or photograph .
• One copy of the manuscript, single-spaced and formatted according to the instructions.
• Title page
-
Title
- Each author's complete name and affiliation. Academic degrees are no longer requested.
- The complete and correct address, phone number, fax number, and e-mail address of the Corresponding Author.

• Structured abstract limited to 250 words for Full-Length Articles and Perspectives
• Acknowledgment section to provide information about funding sources, financial conflicts, ethical board approval, informed consent, HIPAA compliance, clinical trials registration, animal rights, role of each author in the manuscript, and to recognize statistical and other contributors.
• Appendix (if appropriate)
• References
• Figure Captions
• Tables
• Figures (properly formatted and labeled according to the instructions)
• CONSORT statement for Randomized Controlled Trials (if applicable).

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16. REVISED MANUSCRIPTS

Revisions must be returned to the AJO within 3 months to retain revision status; after that time, the Editor-in-Chief may request another cycle of peer-review. The Corresponding Author must reply to each point made in the revision request and may state points of disagreement with the reviewer's comments. Please submit revisions in your account under "Submissions Needing Revision" on Editorial Manager with the files prepared according to online manuscript submission guidelines. Please follow the instructions on the Editorial Manager home page under "Guidelines for Revisions".

17. ACCEPTED MANUSCRIPTS/SUPPLEMENTAL MATERIAL

The Corresponding Author of an accepted Full-Length Article is requested to provide a statement up to 75 words in length for the Table of Contents of the AJO. This statement should be prepared in suitable language for a general ophthalmology audience, describing the rationale, implications, and significance of the accepted Full-Length manuscript. This is different from a version of the Abstract.

The AJO also seeks to further enhance recognition for the contributors of the scientific content in the AJO. Therefore, the first author and the senior author (or both authors if there are only two) of accepted manuscripts will be asked to provide a biographic sketch (limited to 75 words) and a digital photo to be placed on the website linked with the online version at www.AJO.com.

With revision or acceptance of the manuscript, the Corresponding Author may submit Supplemental Material for consideration for posting on the Internet. Appropriate content may include expanded data sets and spreadsheets, additional digitized figures and illustrations, videos, or expanded techniques and methods sections. Supplemental Material must be submitted at the time of revision submission according to specifications, and such material will be edited. When uploading your Supplemental Material on the Attach Files page of Editorial Manager™, please choose Miscellaneous Material for all parts and label each part (e.g., Supplemental Figure Caption, Supplemental Figure 1, Supplemental Video, etc.). If you are including supplemental material with your submission, please note the following on your manuscript title page, "Supplemental Material available at AJO.com" and also note, at the appropriate location in the manuscript and in parenthesis, (Supplemental Material at AJO.com). The Supplemental Material will be forwarded by the AJO office to Dr Peter Kaiser, the AJO Associate Editor supervising the Supplemental Material at AJO.com.

For Supplemental Material, the text must be in Microsoft Word or WordPerfect format, and the digital audio/visual must adhere to the requirements for figures listed above.

DIGITIZED VIDEOS Requirements:
FPS: 8-15 frames per second (fps)
Format: Apple QuickTime, AVI, or MPEG


VIDEOTAPE
Format: VHS, S-VHS, DV-CAM, MiniDV;
Length: Up to 3 minutes

Note: Video should highlight only the desired procedure, lecture, etc. The Editorial Board reserves the right to further edit the tape.

Additional instructions regarding the submission of Figures and Video Supplemental Materials are available at the Elsevier Author Gateway.

18. PUBLICATION PROCESS

The Editor-in-Chief accepts the manuscript with the understanding that the authors cooperate in a timely manner with the production process, including any response to future correspondence from the AJO or its readers. The authors are required to provide an edited print-ready version of the manuscript at the final revision stage (or earlier). The Publisher employs copy editors that format the manuscript to AJO style but do not perform extensive editorial copyediting. The article will then be processed into page proofs, with all art and tables in place. The Production Editor will send the Corresponding Author a galley proof by e-mail or mail, which should be corrected and returned within 48 hours. Authors must check their proofs very carefully, because approval indicates that all copyediting changes have been accepted unless corrections are returned to the Production Editor. Authors must also answer any copyediting queries listed on the last page of the proof. Notification of the costs for printing illustrations in color and page charges will be provided at this proofing stage. An order form for the article reprints will be sent to the Corresponding Author before publication. Reprints should be ordered prior to publication.

Good quality illustrations using the above guidelines must be made available to the printer; the Editor-in-Chief reserves the right to withdraw acceptance at any time if the images do not meet expectations, the authors do not provide them in a timely fashion, or other aspects of the publication process are not diligently followed to the satisfaction of the Editor-in-Chief.

The authors may participate in scientific programs and presentations providing the highlights of the manuscript but should be aware that the manuscript acceptance will be withdrawn if it is published in substantive content elsewhere in print or electronically prior to the AJO publication, per the Policy on Duplicate Publication. After publication of a manuscript in the AJO, the authors and readers may monitor any future citations of the article by specialized software at AJO.com.

19. APPEALS PROCESS
The AJO strives to provide expert reviews of each manuscript. The authors should also recognize that many good studies cannot be published by the AJO because of the space constraints common to many biomedical journals. Less than 25% of submitted manuscripts can be accepted. If you believe your manuscript deserves another evaluation, you may initiate a rebuttal letter to the Editor. The cover letter should contain a detailed rebuttal to each of the reviewer comments.

20. AJO ON THE INTERNET

The AJO Table of Contents and Abstracts for each month are available on the Internet at AJO.com. Forthcoming issue line-ups can also be received through e-mail by signing up for ScienceDirect. The full text of AJO is available online and to recipients of ScienceDirect if they are subscribers to the print edition. Supplemental Material augments Full-Length Articles and Perspectives, and special features present new content on the electronic AJO. InternetAdvance offers the manuscripts that have been accepted but not yet printed in the AJO. Book Reviews and Announcements are also listed in the print issue with more complete information available at AJO.com. The website provides a keyword search and an electronic link to abstracts for many of the references in published material. Authors may track any future citations to their AJO printed manuscripts at AJO.com.

21. AJO POLICIES

A. REJECTION BY PREVIOUS JOURNAL
If the manuscript has been previously rejected or evaluated in any form by another journal, the authors should note that in the cover letter and indicate how they have improved the manuscript.

B. DUPLICATE PUBLICATION
To protect the mission of the AJO as a peer-reviewed journal, only original material will be published in the AJO. Authors who distribute e-prints, preprints, reprints, or substantive content in any format, including digital, of an article into the public domain before publication risk losing the opportunity to publish in the AJO. When authors submit material for publication in the AJO, they must claim the copyright and must transmit copyright of their material to the AJO. Publication of the material elsewhere (duplicate publication) without permission of the AJO is a copyright infringement.

InternetAdvance at AJO.com shows a galley of each article that has been accepted for publication but has not yet appear in print. This permits an article to appear before the print publication without endangering the mission of the peer-reviewed journal.

C. STATEMENTS OF PRIORITY
The AJO discourages statements of priority (such as "we are the first to report...") because of the inability to be familiar with all published works or presentations on a subject. Either consider deleting the statement of priority or provide a standard statement that adheres to AJO policy, such as "we are unaware of previous reports of this finding (phenomenon, procedure, or other appropriate wording) and could find no reference to it in a computerized search (include the name of the database, such as PubMed)."

D. MULTICENTER STUDIES
The AJO encourages the submission of multicenter studies. On the title page, preferably the writing group authors should be listed along with the group name (e.g., Smith TT, Jones JJ, on behalf of the Pediatric Amblyopia Study Group). Other group members should be listed in an appendix before the references. When the study group name alone is listed on the title page, the Copyright Transfer Agreement requires only the original signature of the Corresponding Author.

E. SUGGESTIONS FOR RESEARCH PRESENTERS AT SCIENTIFIC MEETINGS PRIOR TO PUBLICATION
The AJO and the scientific community encourage presentation at meetings. Presenters planning to submit information to a peer-reviewed journal, however, should not share their slides, materials, or additional information with newspapers or tabloids before publication. If the presenter is given a preprint of a planned publication by a newspaper or tabloid, the presenter again could ask the writer to withhold the information until after the information has been published in the peer-reviewed literature. Violations could result in public reprimand regarding copyright infringement and may result in a presenter being subjected to greater scrutiny when future materials are considered for publication in the AJO.

F. SECONDARY PUBLICATION
Secondary publication in the same or another language, especially in other countries, is justifiable, and can be beneficial, provided all of the following conditions are met:
1) The authors have received approval from the editors of both journals; the editor concerned with the secondary publication must have a photocopy, reprint, or manuscript of the primary version.
2) The priority of the primary publication is respected by a publication interval of at least 1 week (unless specifically negotiated otherwise by both editors).
3) The article for secondary publication is intended for a different group of readers; an abbreviated version could be sufficient.
4) The secondary version faithfully reflects the data and interpretations of the primary version.
5) The footnote on the title page of the secondary version informs readers, peers, and documenting agencies that the article has been published in whole or in part and states the primary reference. A suitable footnote might read: "This article is based on a study first reported in the [title of journal, with full reference]."

G. DEFINING AUTHORSHIP CONTRIBUTIONS
All persons designated as authors should qualify for authorship, and all those who qualify should be listed. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content. One or more authors should take responsibility for the integrity of the work as a whole, from inception to published article.

Authors must provide a description of what each contributed in the AJO Contributions of Authors and Sponsors form as well as the Acknowledgment Section of the manuscript. The order of authorship on the byline should be a joint decision of the co-authors. Authors should be prepared to explain the order in which authors are listed.

In multicenter trials, the writing group authors should be listed along with the group name (e.g., Smith TT, Jones JJ, on behalf of the Pediatric Amblyopia Study Group). Other group members should be listed in an appendix before the references.

Once a manuscript has been submitted, the order of authorship (including adding or removing authors) should not be changed. Exceptions must be approved by the Editor-in-Chief and the Corresponding Author. The Corresponding Author is responsible for assuring that all the involved authors concur with the change.

H. CONFLICT OF INTEREST IN PEER-REVIEW PROCESS AND DISCLOSURE
Authors, editors, or reviewers may hold conflicting or competing interests that could result in bias. These conflicts may be real, potential, or perceived. Participants in the peer-review and publication should disclose their conflicting interests, and the information should be made available so that others can judge their effects for themselves.

Specific manuscripts such as Editorials, Perspectives, or Correspondence by their nature present a biased viewpoint. The Editorial Board and the Editor-in-Chief monitor any conflict of interest.

The determination of whether a conflict of interest actually exists can be extraordinarily difficult. Recognizing the potential for conflicts of interest is usually easier; they are common, and it is not their existence, but rather their potential to cause bias and failure to acknowledge or recognize conflict, that causes concern.

Personal, political, financial, academic, or religious considerations should not be permitted to affect objectivity. The challenge for authors, editors, and reviewers should be to recognize the potential for biases arising from conflicts of interest and respond appropriately.

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Financial and Non-financial Conflicts
Many considerations—intellectual, political, academic, and religious— as well as financial can represent "private interests." The challenge for authors, reviewers, and editors is to recognize the potential for these types of conflicts and respond appropriately. Complete objectivity is not often possible, but fairness and even-handedness can reasonably be expected.

A key to dealing with conflicts of interest—financial or non-financial—is disclosure. Disclosure of potential financial conflicts of interest is meant to maintain the integrity of professional judgment and to maintain the integrity of professional judgment. A disclosure does not imply that scientists are unduly influenced by financial gain. Rather, disclosure in such cases gives readers the information to allow them to make an informed decision, because it is often difficult to determine when research has been inappropriately influenced by financial gain. Informing readers is the responsibility of the AJO.

Financial conflicts include salary, consulting fees and honoraria, stock or equity interests, and intellectual property rights (patents, royalties, and copyrights) and sometimes expert witness testimony. The AJO requires authors, reviewers, and editors to declare any financial involvement that they have with commercial entities and some of this information is published in the Acknowledgment section of the article. The AJO does not research or police the possible conflicts of interest. The failure of an author, reviewer, or editor to declare financial interest, however, conflicts with the reader's entitlement to know this potential source of bias.

Conflicts of interest regarding reviewers or editors include financial issues, but also rivalry, academic scientific and technologic competition, and philosophical values and beliefs. Reviewers and editors should indicate any conflicts of interest with regard to a manuscript under review. Reviewers and editors are apt to have conflicts of interest, financial or otherwise, because of their prominent positions. Thus, the existence of a conflict is not really the issue, but rather whether the conflict is sufficient to limit the reviewer's ability to evaluate the manuscript fairly and objectively. AJO reviewers and editors should disqualify themselves if they feel they cannot render fair and objective assessments.

The Editor-in-Chief is responsible for establishing and maintaining the highest possible standards of the AJO as well as for maintaining the integrity of the AJO itself. The Editor-in-Chief and the Editorial Board are primarily responsible for ensuring a fair review process and should give unbiased consideration to all submitted manuscripts. Editors should not have personal financial involvement in manuscripts they consider for publication.

I. CORRECTIONS AND RETRACTIONS
Errors may be noted in published articles that require the publication of a correction or an erratum. Most corrections are minor. Some errors, however, may negate the value of the initial manuscript. These do not include inadequacies exposed by the emergence of new scientific information, in which case no corrections or withdrawals are needed.

If substantial doubts arise about the honesty of a work, either submitted or published, it is the Editor-in-Chief's responsibility to ensure that the possible fraud is addressed. It is not usually the task of the Editor-in-Chief to conduct a full investigation or to make a determination; that responsibility lies with the institution where the work was done or with the funding agency. The Editor-in-Chief should be promptly informed of the final decision of the institution involved, and if a fraudulent article has been published, the AJO will print a retraction. If the study was not under the aegis of an IRB or if this method of investigation does not result in a satisfactory conclusion, the Editor-in-Chief may choose to publish an expression of concern with an explanation or a full retraction, following an attempt for clarification from the authors.

The Editor-in-Chief may ask the authors' institution to assure them of the validity of earlier work published in the AJO or to retract it.

J. CONFIDENTIALITY
The Editorial Board and reviewers should respect authors' confidentiality because authors have entrusted the AJO with the results of their scientific work and creative effort. Authors' rights may be violated by disclosure of the confidential details of the review of their manuscript.

Reviewers also have rights to confidentiality, which must be respected. Editors should not disclose information about manuscripts (including their receipt, their content, their status in the reviewing process, their criticism by reviewers, or their ultimate fate) to anyone other than the authors themselves and reviewers.

Editors should make clear to their reviewers that manuscripts sent for review are privileged communications and are the private property of the authors. Therefore, reviewers and members of the Editorial Board should respect the authors' rights by not publicly discussing the authors' work or appropriating their ideas before the manuscript is published. Reviewers should not be allowed to make copies of the manuscript for their files and are prohibited from sharing it with others, except with the permission of the editor.

K. CONDUCT AND COMMUNICATION OF CLINICAL TRIALS
The AJO recommends that researchers and authors (and commercial companies) adopt and adhere to the Pharmaceutical Research and Manufacturers (PhRMA) "Principles for the Conduct of Clinical Trials and Communication of Clinical Trial Results" listed at the PhRMA website. These principles describe the relationship of PhRMA member companies with others involved in clinical research and set forth the rules companies have volunteered to follow in order to protect the safety of research participants wherever the companies conduct clinical trials. In the principles, the PhRMA companies commit to the timely communication of all meaningful results of clinical trials, whether those results are positive or negative. The principles further state that the results should be communicated in an objective, accurate, balanced, and complete manner.

L. AJO ACCESS TO SCIENTIFIC DATA
Thorough peer review by the AJO may require that organizations that sponsor research provide access to data and analyses that are not provided in a submitted manuscript, and sometimes such access is needed after publication as well. The opportunity also exists to post this information on the AJO website as Supplemental Material in association with the published manuscript.

M. REPORTING NEW MICROBIAL ORGANISMS IN OPHTHALMIC INFECTIONS
The AJO is interested in confirming that certain organisms participate in ocular disease. The text must provide adequate laboratory information that can substantiate the microbial identification. This requires that any unusual pathogen be confirmed by two different methods or at two independent laboratories. The journal Cornea initiated this confirmatory policy (Wilhelmus KR. New corneal infections: preventing a crisis of identity. Cornea 2003;22:95-96).

N. CANCER CLASSIFICATION SCHEME
Authors should use the American Joint Commission on Cancer classification scheme when describing patients with ophthalmic malignancies; see American Joint Committee on Cancer. JCC Cancer Staging Manual, Seventh Edition, Springer, New York.

O. OCULAR TRAUMA TERMINOLOGY
It is suggested that the terminology used in descriptions of ocular trauma should conform to the recommendations of the United States Eye Injury Registry and the International Society of Ocular Trauma (Birmingham Eye Trauma Terminology [BETT], Kuhn F, Morris R, Witherspoon D, et al. A standardized classification of ocular trauma. Ophthalmology 1996;103:240-243).

P. CLINICAL TRIALS REGISTRATION
The AJO requires that human clinical trials have to be registered before enrollment in order for the results to be published in the AJO. See Arch Ophthalmol 2005:123:1263-1264 for complete statement. Phase III trials should be registered as well as many phase II trials. Most phase I trials do not need to be registered. The Acknowledgment section should contain a statement about where the registration information is available to the public. Satisfactory public databases include the National Institute of Health maintained site at External link http://www.clinicaltrials.gov (for either NIH or non-NIH sponsored studies) or the International Standard Randomized Controlled Trials at External link http://www.controlled-trials.com.

22. FORMS
A. AUTHOR DISCLOSURE STATEMENT
B. CONTRIBUTIONS OF AUTHORS AND SPONSORS FORM
C. CONSORT STATEMENT (External link http://www.consort-statement.org )
D. CONSENT FORM FOR IDENTIFIABLE PHOTOGRAPHS



23. GLOSSARY OF STUDY DESIGN

Randomized Clinical Trial: A human trial involving at least one experimental treatment group and one control treatment group, concurrent enrollment, and follow-up of the experimental and control groups with assignment to experimental and control groups by a randomization process. Persons responsible for treatment and subjects are not able to influence the treatment assignment, and assignment remains unknown to the staff and subjects until eligibility has been determined.

Nonrandomized Clinical Trial: A human trial involving at least one experimental treatment group and one control group, concurrent enrollment, and follow-up of the treatment and control groups. Assignment to experimental control groups is by a process other than randomization.

Interventional Case Series: Three or more cases, which may or may not be consecutive, that describe the outcome of an intervention without a control group for comparison.

Interventional Case Report: One or two cases that describe the outcome of an intervention.

Cohort Study: A longitudinal observational study that includes subjects with identifying characteristics and involves measurements or observations on more than one occasion.

Case-control Study: An observational, and usually retrospective, study of subjects with identifying characteristics and a disease or abnormality (cases) for comparison to subjects with similar characteristics, but without the disease or abnormality (controls). Comparison proceeds from effect to cause and generally yields odds ratio (usually an approximation of relative risk).

Cross-sectional Study: An observational study that identifies subjects with and without the disease or abnormality being studied at the same time. Study yields prevalence data and may or may not be population based.

Observational Case Series: Three or more cases in which natural history of the disease or abnormality is described. Cases may be collected and studied retrospectively or prospectively over any time frame.

Observational Case Report: One or two cases in which the natural history of the disease or abnormality is described. The single case or two cases may be studied retrospectively prospectively over any time frame.

Experimental Study: Animal or laboratory research describing observations, surgical or medical interventions, testing, or devices. Experimental studies are generally prospective and utilize a protocol in which controls are included.

Meta-analysis of Literature: Analysis of literature using statistical methods to integrate and summarize several studies.

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Revised April 2009
 
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