The Archives of General Psychiatry strives to publish original, state-of-the-art studies and commentaries of general interest to clinicians, scholars, and research scientists in psychiatry, mental health, behavioral science, and allied fields. Archives seeks to inform and to educate its readers as well as to stimulate debate and further exploration into the nature, causes, treatment, and public health importance of mental illness.
Manuscript Submission
Manuscripts should be submitted via our online submission and review system. Print mail and e-mail addresses 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 or fax. See details in these Instructions for additional requirements.
Editorial Office Contact Information
Joseph T. Coyle, MD, Editor, Archives of General Psychiatry, McLean Hospital, 115 Mill St, Belmont, MA 02478 USA; telephone: (617) 855-2170; fax (617) 855-2579; e-mail: archgenpsychiatry{at}jama-archives.org.
Categories of Articles
Original Articles. The vast majority of articles published in the Archives describe the results of original research relevant to the nature, causes, treatment, and the public health impact of mental illness.
Reviews. The Archives publishes a small number of unsolicited review articles. Potentially acceptable articles should have field-altering impact, reframing current hypotheses or identifying underappreciated avenues of investigation.
Meta-analyses. The Archives will consider a meta-analysis when there are sufficient data and when the meta-analysis provides compelling findings that affect the understanding of the causes and treatment of mental illness.
Letters to the Editor. Letters to the Editor will be considered for publication if they are accompanied by a cover letter stating that they are “for publication.” Their purpose should be to comment on articles published in the Archives.
Editorial Policies for Authors
Authorship Criteria and Contributions. With the cover letter include (1) the statement on and checklist for authorship responsibility, criteria, and contributions, (2) the statement on financial disclosure, and either the statement on copyright or the statement on federal employment. Each of these 3 statements must be read and signed by all authors.1(pp127-132) (3) The corresponding author must sign the acknowledgment statement. (See Authorship Form.)
Corresponding Author. Designate a corresponding author and provide a complete address, telephone and fax numbers, and e-mail address. The corresponding author will be identified as such in the published article.
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 the Authorship Form. 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.1(p135-138),2
Conflicts of Interest and Financial Disclosure. A conflict of interest may exist when an author (or the author’s institution or employer) has financial or personal relationships or affiliations that could inappropriately influence (or bias) the author’s decisions, work, or manuscript. All authors are required to disclose all potential conflicts of interest, including specific financial interests and relationships and affiliations (other than those affiliations listed on the title page of the manuscript) relevant to the subject of their manuscript. Authors should err on the side of full disclosure and should contact the editorial office if they have questions or concerns. All such disclosures should be listed in the Acknowledgment section at the end of the manuscript. Authors without conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject of their manuscript, should include a statement of no such interest in the Acknowledgment section of the manuscript. Failure to include this information in the manuscript may delay evaluation and review of the manuscript.
Authors are expected to provide detailed information about all relevant financial interests and relationships or financial conflicts within the past 5 years and for the foreseeable future (eg, employment/affiliation, grants or funding, consultancies, honoraria, speakers bureau, stock ownership or options, expert testimony, royalties, patents filed, received, or pending, or donation of medical equipment), particularly those present at the time the research was conducted and through publication, as well as other financial interests (such as patent applications in preparation) that represent potential future financial gain. Although many universities or other institutions have established policies and thresholds for reporting financial interests and other conflicts of interest, the Archives of General Psychiatry requires complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value. For example, authors of a manuscript about depression should report all financial relationships they have with all manufacturers of products used in the management of depression, not only those relationships with companies whose specific products are mentioned in the manuscript. If authors are uncertain about what constitutes a relevant financial interest or relationship, they should contact the editorial office.
For all accepted manuscripts, each author’s disclosures of conflicts of interest and relevant financial interests and affiliations and declarations of no such interests will be published. The policy of the Archives of General Psychiatry is one of complete disclosure of all potential conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject of their manuscript.3 This policy applies for all manuscript submissions, including letters to the editor and book reviews. If an author’s disclosure of potential conflicts of interest is determined to be inaccurate or incomplete after publication, a correction will be published to rectify the original published disclosure statement.
All authors must also complete and sign a statement on financial disclosures, funding, and support that is a part of the Authorship Form.
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 Responsiblity. For reports containing original data, at least 1 author (eg, the principal investigator) should indicate that she or he takes responsibility for the integrity of the data and the accuracy of the data analysis, and that all authors had full access to all the data in the study.4,5 For industry-sponsored studies, this statement must be provided by an investigator who is not employed by any commercial funder, and an independent data analysis must be conducted by statisticians at an academic institution with access to the raw data set, rather than only by statisticians employed by the company sponsoring the research. Details of the independent statistical analysis, the name and institutional affiliation of the independent statistician, and whether compensation or funding was received for conducting the analysis should be reported in the Acknowledgment.
Statistical Analysis. Include a statistical analysis section under “Methods” that fully describes the application of each statistical procedure used. If a test is used that is not commonly presented in the Archives, briefly describe its purpose and how it is to be interpreted. Results should report the test statistic (eg, χ2, F, or t value), degrees of freedom, and P value or confidence limits. Measures of central tendency (eg, means) should be accompanied by measures of variability (eg, SDs).
Duplicate/Previous Publication or Submission. Manuscripts are received with the understanding that they have the approval of each author, are not under simultaneous consideration by another publication, and have not been published previously in whole or substantial part. This policy applies to the essential contents, tables, or figures, but does not apply to abstracts. Authors must disclose in their cover letters if the submitted manuscript contains any data, patient information, or other material or results that have already been published or are in press, submitted, or nearly submitted. Copies of closely related manuscripts should be submitted to the Editor for examination. Accepted manuscripts become the permanent property of the Archives. They may not be republished without permission from the publisher (AMA).
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 and Confidentiality. A statement of informed consent for human investigation should be made in the text, along with the name of the institutional review board that approved the study protocol. Authors must ensure that patient confidentiality is in no way breached. Do not use real names, initials, or disclose information that might identify a particular person without informed consent for publication.
Patient Descriptions, Photographs, and Pedigrees. Include a signed statement of informed consent to publish (in print and online) patient descriptions, photographs, and pedigrees from all persons (parents or legal guardians for minors) who can be identified in such written descriptions, photographs, or pedigrees. (See Patient Consent Form.)
Personal Communications and Unpublished Data. A signed statement of permission should be included from each individual identified as a source of information in a personal communication or as a source for unpublished data, and the date of communication and whether the communication was written or oral should be specified.1(p199)
Embargo Policy. Information regarding the content and publication date of accepted manuscripts is confidential. Information contained in or about accepted articles cannot appear in print, radio, television or in electronic form or be released in the media until 3 pm CST on the first Monday of the month.
Editorial Review and Publication
Review Process. A submitted manuscript will be acknowledged and assigned a manuscript number, which is to be used in all further correspondence. Manuscripts are reviewed and given a priority based on their originality, importance of the findings, scientific merit and significance for the field, interest to readers, lucidity, and suitability for publication. Manuscripts with insufficient priority for publication are rejected promptly. Other manuscripts are sent to expert consultants for peer review. Author identities are not kept confidential. The existence of a manuscript under review is not revealed to anyone other than peer reviewers and editorial staff. Peer reviewers remain anonymous and are expected to maintain strict confidentiality. Reviewers are also expected to inform the Editor of any conflicts of interest, including any financial arrangements involving companies whose products (or competing products) are featured in the manuscripts they agree to review. After the review process has been completed, authors will be informed by mail of the Editor’s decision.
When a potential conflict of interest (eg, same institution, collaborator) occurs for the Editor or the Associate Editor in the review and potential acceptance of a manuscript, the final editorial decision will be made by a member of the editorial board who does not have such a potential conflict.
Revised Manuscripts. Revised manuscripts must be submitted to the editorial office within 90 days of the receipt of the reviews unless a waiver is granted by the Editor. Manuscripts that exceed this time limit will be handled as new submissions.
Editing. Copyediting follows AMA style and requires corresponding author approval. The authors are responsible for all statements made in their work, including changes made by the copy 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 60654; 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.
Manuscript Preparation and Submission Requirements
Manuscripts should be prepared in accordance with the AMA Manual of Style1 and/or the Uniform Requirements for Manuscripts Submitted to Biomedical Journals.7 Double-space the manuscript and leave right margins unjustified (ragged). Each manuscript component should begin on a new page, in the following sequence: title page, abstract, text, acknowledgments, references, figure legends, tables, and figures. Pages should be sequentially numbered in the upper right-hand corner, beginning with the title page. Do not use line numbering. The text of the manuscript must not exceed 4500 words, exclusive of references, tables, and figure legends. The total number of text words should be displayed on the title page of the manuscript.
Cover Letter. Include a cover letter and complete contact information for the corresponding author (postal/mail address, e-mail address, and telephone and fax numbers) and whether the authors have published or submitted any related papers from the same study. (See Duplicate/Previous Publication or Submission.)
Title Page. The title page should list full names, degrees, academic affiliations and locations of each author, and the name and address to whom reprint requests should be sent. If the paper was presented at a meeting, include the organization, place, and date of presentation. Acknowledgment of all funding support for the work should also be made on this page. Titles should be short, specific, and descriptive, emphasizing the main point of the article. Avoid a 2-part title, if at all possible. Do not number the title, eg, I or Part I. Do not make a declarative statement in the title. Title length, including punctuation and spaces, ideally should be under 100 characters and must not exceed 150 characters.
Abstract. Include a structured abstract of no more than 300 words for reports of original data, reviews, and meta-analyses. (See Preparing Structured Abstracts.) For other major manuscripts, include an unstructured abstract of no more than 200 words that summarizes the objective, main points, and conclusions of the article. Abstracts are not required for editorials, commentaries, and special features.
Abbreviations. Do not use abbreviations in the title or abstract. Limit their use in the text.
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.
Names of Drugs.
Use generic names of drugs, unless the specific trade name is directly relevant to the study design or discussion.
Gene Names, Symbols, and Accession Numbers. Authors describing genes or related structures in a manuscript should include the names and official symbols provided by the US National Center for Biotechnology Information (NCBI) or the HUGO Gene Nomenclature Committee. Before submission of a research manuscript reporting on large genomic data sets (eg, protein or DNA sequences), the data sets should be deposited in a publicly available database, such as NCBI’s GenBank, and a complete accession number (and version number, if appropriate) must be provided in the “Methods” section or the Acknowledgments section of the manuscript.
Reproduced Material. Acknowledge all illustrations or tables adapted or reproduced from other publications and submit written permission to reproduce (in print and online and in licensed versions) from the original publishers. (See Permission to Reproduce Copyright-Protected Material Form.)
References. These should be carefully selected to acknowledge previous work or to document a specific point. They should not be exhaustive. Number references in the order they are mentioned in the text; do not alphabetize. In text, tables, and legends, identify references with superscript arabic numbers. Double-space, follow JAMA/Archives style and abbreviate names of journals according to Index Medicus style. List all authors and/or editors. Citation accuracy is the responsibility of the author.
Examples:
- 1. Ettinger U, Picchioni M, Landau S, Matsumoto K, van Haren NE, Marshall N, Hall M-H, Schulze K, Toulopoulou T, Davies N, Ribchester T, McGuire PK, Murray RM. Magnetic resonance imaging of the thalamus and adhesio interthalamica in twins with schizophrenia. Arch Gen Psychiatry. 2007;64(4):401-409.
- 2. Johnson LD, O’Malley PM, Bachman JG, Schulenberg JE. Monitoring the Future: National Survey Results on Drug Use, 1975-2004. Bethesda, MD: National Institute on Drug Abuse; 2005.
- 3. Centers for Medicare and Medicaid Services. Medicare Current Beneficiary Survey. http://www.cms.hhs.gov/apps/mcbs/. Accessed May 16, 2007.
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.
Tables and Figures. Tables and figures should provide substantive data and not merely illustrate the text. While the main finding of a table or figure may be discussed in the narrative, the table or figure should not duplicate the text. Although no specific guideline can be applied to all articles, the number and length of tables and figures should be kept to a minimum.
Tables. Number all tables in the order of their citation in the text. Include a title for each table (a brief phrase, preferably no longer than 10 to 15 words). If a table must be continued, repeat the title on a second sheet, followed by “(cont).” Tables should contain sample sizes and units of measurement, when appropriate. Any explanatory notes to be printed with the table must be typed single-spaced beneath the table. 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 for more specific guidelines.
Figures. Figures at submission must be of sufficient quality for peer review. If your manuscript is accepted, you will be asked to submit a high-quality original of each figure. Illustrations in full color are accepted for publication at no charge to the author if the editor believes that color will add significantly to the published manuscript. Number figures according to their order in the text. Include sample size. See Technical Requirements for Figures for specific guidelines at submission and acceptance.
Image Integrity. Preparation of scientific images (clinical images, radiographic images, micrographs, gels, etc) for publication must preserve the integrity of the image data. Digital adjustments of brightness, contrast, or color applied uniformly to an entire image are permissible as long as these adjustments do not selectively highlight, misrepresent, obscure, or eliminate specific elements in the original figure, including the background. Selective adjustments applied to individual elements in an image are not permissible. Individual elements may not be moved within an image field, deleted, or inserted from another image. Cropping may be used for efficient image display but must not misrepresent or alter interpretation of the image by selectively eliminating relevant visual information. Juxtaposition of elements from different parts of a single image or from different images, as in a composite, must be clearly indicated by the addition of dividing lines, borders, and/or panel labels.
When inappropriate image adjustments are detected by the JAMA and Archives Journals staff, authors will be asked for an explanation and will be requested to submit the image as originally captured prior to any adjustment, cropping, or labeling. Authors may be asked to resubmit the image prepared in accordance with the above standards. Deliberate alteration of images that results in misrepresentation of data may be reported to the author’s institution or funding agency.
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.
If the author does not hold copyright to the video, the author must obtain permission for the video to be published in Archives of General Psychiatry. This permission must be for unrestricted use in all print, online, and licensed versions of Archives of General Psychiatry. (See Permission to Reproduce Copyright-Protected Material Form.) Submit the completed form to the editorial office.
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.
Preparing Structured Abstracts
All reports of original data, reviews, and meta-analyses should be submitted with structured abstracts as described below. No information should be reported in the abstract that does not appear in the text of the manuscript. The following is adapted from Haynes et al.8
Reports of Original Data
Reports of original data should include an abstract of no more than 300 words using the following headings: Context, Objective, Design, Setting, Patients (or Participants), Interventions (include only if there are any), Main Outcome Measure(s), Results, and Conclusions. For brevity, parts of the abstract should be written as phrases rather than complete sentences. The content following each heading should be as follows:
- 1. Context. The abstract should begin with a sentence or 2 explaining the clinical (or other) importance of the study question.
- 2. Objective. A precise objective or study question addressed in the report should be stated (eg, “To determine whether . . .”). If more than 1 objective is addressed, the main objective should be indicated and only key secondary objectives stated. If an a priori hypothesis was tested, it should be stated.
- 3. Design. The basic design of the study should be described. The years of the study and the duration of follow-up, if any, should be stated. As many of the following terms as apply should be used.
- A. For 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 modeling of clinical predictions.
- D. For studies of causation or association: randomized controlled trial; cohort; survey; case-control.
- 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 identified and the basic study design disclosed.
- 4. 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, or ambulatory or hospitalized care.
- 5. 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 because of 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.
- 6. 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, and nonproprietary drug names should be used.
- 7. Main Outcome Measure(s). The primary study outcome measurement(s) should be indicated as planned before data collection began. If the manuscript does not report the main planned outcomes of a study, this fact should be stated and the reason indicated. If the hypothesis being tested was formulated during or after data collection, this information should be clearly stated.
- 8. Results. The main outcomes of the study should be provided and quantified, including confidence intervals (for example, 95%) or P values. For comparative studies, confidence intervals should relate to the differences between groups. Measurements that require explanation for a general medical readership 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. If differences for the major study outcome measure(s) are not significant, 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. Approaches such as number needed to treat to achieve a unit of benefit are encouraged when appropriate; reporting of relative differences alone is insufficient. Studies of screening and diagnostic tests should report sensitivity, specificity, and likelihood ratio. If predictive value or accuracy is given, prevalence or pretest likelihood should be given as well. All randomized controlled trials should include the results of intention-to-treat analysis, and all surveys should include response rates.
- 9. Conclusions. Only those conclusions of the study that are directly supported by the evidence reported should be given, along with implications for clinical practice (avoiding speculation and overgeneralization). The conclusion should indicate 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.
Systematic Reviews and Meta-analyses
Manuscripts reporting the results of reviews or meta-analyses should include an abstract of no more than 300 words using the following headings: Context, Objective, Data Sources, Study Selection, Data Extraction, Data Synthesis, and Conclusions. The text of the manuscript should also include a section describing the methods used for data sources, study selection, data extraction, and data synthesis. Each heading should be followed by a brief description:
- 1. Context. The abstract should begin with a sentence or 2 explaining the clinical (or other) importance of the review question.
- 2. Objective. The precise primary objective of the review should be stated. 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 tests or outcomes that are being reviewed.
- 3. Data Sources. A succinct summary of data sources should be given, including years searched. Potential sources include computerized databases and published indexes, registries, abstract booklets, conference proceedings, references identified from bibliographies of pertinent articles and books, experts or research institutions active in the field, and companies or manufacturers of tests or agents being reviewed. If a bibliographic database is used, the exact indexing terms used for article retrieval should be stated, including any constraints (for example, English language or human subjects) and the dates of the search. If abstract space does not permit this level of detail, sources should be summarized in the abstract including databases and years searched, and the remainder of the information should be placed in the “Methods” section.
- 4. Study Selection. Inclusion and exclusion criteria used to select studies for detailed review from among studies identified as relevant to the topic should be described. Details of selection should include particular populations, interventions, outcomes, or methodologic designs. The method used to apply these criteria should be specified (for example, blinded review, consensus, multiple reviewers). The proportion of initially identified studies that met selection criteria should be stated.
- 5. 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).
- 6. 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 should summarize survival characteristics and related variables. Major identified sources of variation between studies should be stated, including differences in treatment protocols, co-interventions, confounders, outcome measures, length of follow-up, and dropout rates.
- 7. Conclusions. The conclusions and their applications (clinical or otherwise) should be clearly stated, limiting interpretation to the domain of the review. The need for additional studies may be suggested.
Reports of Randomized Controlled Trials
Manuscripts reporting the results of randomized controlled trials should include the CONSORT flow diagram as a figure in the manuscript to illustrate the progress of all patients in the study (Figure). In addition, the CONSORT checklist should be completed and submitted with the manuscript.
Flow diagram of subject progress through the phases of a randomized trial. Adapted from Moher D, Schulz KF, Altman D, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285(15):1987-1991.
Trial Registration
In concert with the International Committee of Medical Journal Editors (ICMJE),9,10 Archives of General Psychiatry will require, as a condition of consideration for publication, registration of all trials in a public trials registry that requires the minimum registration data set as determined by the World Health Organization and the ICMJE (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). Trials must be registered at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after March 1, 2006. For trials that began enrollment before this date, registration will be required by June 1, 2006, before considering the trial for publication. For this purpose, the ICMJE defines a clinical trial as any study that prospectively assigns human subjects to intervention or comparison groups to evaluate 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. The trial registry name, registration number, and the URL for the registry should be included at the end of the abstract.
References
- 1. Iverson CL, Christiansen S, Flanagin AF, Fontanarosa PB, Glass RM, Gregoline B, Lurie SJ, Meyer HS, Winker MA, Young RK. AMA Manual of Style: A Guide for Authors and Editors. 10th ed. New York, NY: Oxford University Press; 2007.
- 2. Flanagin A, Fontanarosa PB, DeAngelis CD. Authorship for research groups. JAMA. 2002;288(24):3166-3168. FULL TEXT | MEDLINE
- 3. Coyle JT, Heckers S. Update on the conflict of interest policy for the Archives. Arch Gen Psychiatry. 2006;63(11):1178. FULL TEXT
- 4. Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Højgaard L, Horton R, Kotzin S, Nicholls MG, Nylenna M, Overbeke AJPM, Sox HC, Van Der Weyden MB, Wilkes MS. Sponsorship, authorship, and accountability. JAMA. 2001;286(10):1232-1234. 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
- 6. Winker M. Measuring race and ethnicity: why and how? JAMA. 2004;292(13):1612-1614. FULL TEXT | MEDLINE
- 7. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals. http://www.icmje.org. Updated February 2006.
- 8. Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Ann Intern Med. 1990;113(1):69-75.MEDLINE
- 9. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MG; International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292(11):1363-1364. FULL TEXT | MEDLINE
- 10. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Soc HC, Van Der Weyden MG; International Committee of Medical Journal Editors. Is this clinical trial fully registered? a statement from the International Committee of Medical Journal Editors. JAMA. 2005;293(23):2927-2929. FULL TEXT | MEDLINE
Last updated: May 2009.