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Information for Authors

Mission

The mission of Annals of Internal Medicine is to promote excellence in the practice of internal medicine and in clinical research. We publish original research, guidelines, narrative and systematic reviews, and essays and commentary on a broad range of topics related to the care of adults and adolescents. Our intended readership includes clinicians, clinical researchers, managers, and other persons involved in providing medical care. We are most interested in papers that will influence practice and that address important advances in internal medicine. Annals circulation is over 90,000, and our impact factor is 17.5.

Manuscript Preparation

General Guidelines

General Considerations

Annals has several categories of articles, each with its own requirements (Table). We publish original research that addresses prevalence, causes, mechanisms, diagnosis, course, treatment, and prevention of disease. We consider various study types, including meta-analyses and cost-effectiveness analyses, as original research. We divide original research into two categories: Original Articles (3200 or fewer words) and Brief Communications (1500 or fewer words). Brief Communications usually address preliminary or limited results of original research, including case series and important case reports of new, serious adverse drug effects. We consider both narrative and systematic reviews. Narrative reviews are especially suitable for describing cutting-edge and evolving developments, and discussing those developments in light of underlying theory. Systematic reviews are especially suitable for critiquing and summarizing a body of evidence relevant to focused questions about diagnostic, prognostic, or therapeutic clinical practices. For narrative reviews, we ask that authors include a box listing 3 to 7 take-home points that link back to the original questions that the review set out to answer. We also publish guidelines, position papers, letters, and essays about controversial medical issues, medical history, medicine and public policy, and patients’ or physicians’ experiences of illness.

Requirements for all categories of articles largely conform to the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals,” developed by the International Committee of Medical Journal Editors (ICMJE). Authors should write for a sophisticated general medical readership; follow principles of clear scientific writing (Gopen, Huth, CBESMC) and statistical reporting (Bailar, Lang); and prepare manuscripts according to recommended reporting guidelines and checklists (EQUATOR) whenever possible.

We consider only online submissions (click here to submit online). When submitting manuscripts, authors should also submit a copy of the original research protocol and other supplemental data as attachments if you think they would help the editors or reviewers to better understand the work. Include reprints of published papers and manuscripts of papers in press that contain data that appear in the submitted manuscript to help the editors form a judgment about the degree of duplicate publication (see Acknowledge Previous or Duplicate Publication and Duplicate Submission). Be prepared to provide original study data if requested by the editors.

Article Types TOP

Section	Description	Word Limit	Abstract Type*	Miscellaneous Considerations
Original Research	Reports of original research on prevalence, causes, mechanisms, diagnosis, course, treatment, and prevention of disease. More details	3200	Structured 275 or fewer words	Follow standard reporting guidelines - see links under specific article types. 75 or fewer bibliographic references; about 4 tables or figures.
Original Research: Brief Communications	Preliminary or limited results of original research on the causes, mechanisms, diagnosis, course, treatment, and prevention of disease.	1500	Structured 175 or fewer words	20 or fewer bibliographic references; about 2 tables or figures.
Abroad	Reports on health care in countries other than the United States. More details	2000	Unstructured 175 or fewer words	10 or fewer bibliographic references; 1 table or figure.
Academia and Clinic	Descriptions and evaluations of innovations in medical education, training, and research methodology. More details	1500-4000 depending on article type	Structured or unstructured depending on article type
Ad Libitum	Poetry. More details	80 lines	None
Clinical Guidelines and Position Papers	Summaries of official or consensus positions on issues related to clinical practice, health care delivery or public policy. More details	4000	Unstructured 275 or fewer words	Include procedures used to formulate guideline recommendations and a bibliography of sources upon which the guideline recommendations are based.
Editorials	Commentary on current topics or on papers published elsewhere in the issue. More details	1200	None	20 or fewer bibliographic references; no tables or figures; most are solicited by the Editors.
History of Medicine	Essays, reports, or biographic sketches on the evolution or language of medicine. More details	3200	Unstructured 275 or fewer words
Improving Patient Care	Reports of original research, reviews, and perspectives on improving the quality of patient care and avoiding medical errors. More details	1500-4000 depending on article type	Structured or unstructured depending on article type
In the Balance	Views on unsettled questions of diagnosis and treatment, particularly questions arising on common, important clinical problems. More details	2000	Unstructured 175 or fewer words	Usually includes two papers presenting differing views and may be accompanied by an editorial; are often solicited by the Editors; 20 or fewer bibliographic references.
Letters: Clinical Observations	Short research or case reports. More details	600	None	If you report an adverse drug reaction (ADR), follow reporting guidelines for ADRs (see Edwards). Maximum of 5 authors and 5 references.
Letters: Comments and Response	Comments and Response on papers published in Annals. More details	400	None	Maximum of 3 authors and 5 references.
Medicine and Public Issues	Papers on the economic, ethical, sociologic, or political environment in medicine. More details	2500	Unstructured 175 or fewer words
On Being a Doctor	Short essays on illuminating experiences in practice. More details	1500	None	Fiction is welcome.
On Being a Patient	Short essays by physicians on their own experiences of illness and accounts written by patients or their families. More details	1500	None	Fiction is welcome.
Perspective	Essays representing opinions, presenting hypotheses, or considering controversial issues. More details	1500	Unstructured 175 or fewer words	20 or fewer bibliographic references; about 2 tables or figures.
Reviews: Narrative	Descriptions of cutting-edge and evolving developments, and underlying theory. More details	4000	Unstructured 275 or fewer words	Include a box (summary table) that lists concisely 3 to 7 take-home points of the review.
Reviews: Systematic & Meta-Analyses	Reviews that systematically find, select, critique, and synthesize evidence relevant to well-defined questions about diagnosis, prognosis, or therapy. More details	4000	Structured 275 or fewer words	Include a flow diagram that depicts search and selection processes, and evidence tables.
Personae	Photographs that capture the personality of people (adults) in the context of their daily lives. More details		None	Submit vertically-oriented black-and-white photographs; must obtain written permission from the subject(s); photographs are not returned.

Manuscript Format and Style TOP

Guidelines and checklists are available for the reporting of essential elements of many types of manuscripts. These guidelines are linked in the Article Types and Specific Article Types sections of the Information for Authors. We expect authors to include the elements suggested by the guidelines and checklists as appropriate

We advise authors to arrange components of manuscripts in the following order (see below for further instructions): title page, abstract, text, acknowledgements (if any), references, tables in numerical sequence, figure legends, figures in numerical sequence, and appendices (if any). Number all pages consecutively, starting with the title page. List the word count of the text of the manuscript at the bottom of the title page. Double space the text of the manuscript.

Do not use abbreviations unless absolutely necessary; do abbreviate long names of chemical substances and terms for therapeutic combinations, such as MOPP. Abbreviate names of tests and procedures that are better known by their abbreviations than by the full name (VDRL test, SMA-12). Abbreviate units of measurement when they appear with numerals (…measured in milliliters, but 10 mL). Use abbreviations in figures and tables to save space. Explain all abbreviations used in the figure legend or table footnote.

Use generic names for all drugs. You may refer to an instrument by its proprietary name; give the name and location of the manufacturers in parentheses in the text. Use SI units throughout (Young). When reporting values for commonly studied components (α₁-antitrypsin, ammonia, bilirubin, calcium, cholesterol, creatinine, creatinine clearance, digoxin, estradiol, glucose, iron, iron-binding capacity, lead, lipids [total], lipoproteins, magnesium, phosphate, testosterone, thyroxine [T₄], triglycerides, and urea nitrogen), report the value in SI units with traditional units given in parentheses.

Title Page TOP

Title: Give the main title and subtitle (if any). If the study is a randomized trial, add that descriptor as the subtitle at the end of the title. If it is a systematic review, narrative review, or meta-analysis, put that information at the beginning of the title, followed by a colon. Use titles that stimulate interest, are easy to read and concise (12 words or fewer), and contain enough information to convey the essence of the article. Also provide a short or “running” title of 7 or fewer words.

Authors: List authors in the order in which they are to appear in the byline of the published article. In the case of group authorship, identify one or more authors who will have responsibility for the publication. Give the institutional affiliation for each author, financial support information, contact information for the corresponding author, and contact information for the author to receive reprint requests.

Word Count: List the word count for the text of the manuscript. Don’t include the abstract or the references in word counts.

Abstracts TOP

Abstracts should accompany all submissions except Editorials, On Being a Doctor/On Being a Patient pieces, and Clinical Observations (research letters). Use unstructured formats and limits of 175 or fewer words for abstracts of the following: Perspective, In the Balance, Abroad, and Medicine and Public Policy. Use unstructured formats and limits of 275 or fewer words for abstracts of Narrative Reviews, Position Papers, and History of Medicine. Use structured abstracts of 275 or fewer words for Original Research (Brief Communications 175 or fewer words), Cost-Effectiveness Studies, and Systematic Reviews, including Meta-analyses (Cook, Haynes). Organize structured abstracts for these articles, as shown below.

Original Research

Background, Objective, Design, Setting, Patients, Intervention (if any), Measurements, Results, Limitations, Conclusions. If the study is a randomized, controlled trial, list where the trial is registered and the trial’s unique registration number at the end of the abstract.

Cost-Effectiveness Studies

Background, Objective, Design, Data Sources, Target Population, Time Horizon, Perspective, Interventions, Outcome Measures, Results of Base-Case Analysis, Results of Sensitivity Analysis, Limitations, Conclusions.

Systematic Reviews, including Meta-analyses

Background, Purpose, Data Sources, Study Selection, Data Extraction, Data Synthesis, Limitations, Conclusions.

Manuscript Text TOP

For original articles, economic analyses, systematic reviews, and meta-analyses, use four main headings when arranging text: Introduction, Methods, Results, and Discussion. Aim for clear, concise, logically organized presentations. Use active voice whenever possible. Specific guidance ON content follows.

Introduction: Use short introductions that concisely set up the context of the research for readers. Always end the introduction with a clear statement of the study’s objectives or hypotheses.

Methods: For studies involving humans, describe in the Methods section how participants were assembled and selected, and the sites or setting from which they were recruited. Then describe study procedures including any interventions, measurements and data collection techniques. Use figures to diagram study processes including the flow of participants through the study. Provide the number of patients at each stage of recruitment and follow-up, including the number who declined to participate and the number who completed follow-up. State, if true, that an institutional review board approved the study or affirm that the protocol is consistent with the principles of the Declaration of Helsinki (World Medical Association), and state whether participants gave their informed consent. For studies that have numerical data and use statistical inference, include a section under Methods that describes the methods used for the statistical analysis and that states the specific statistical software. For all studies, include a statement at the end of the Methods section describing the role of the funding source for the study. If the study had no external funding source or if the funding source had no role in the study, state so explicitly.

Results: Fully describe the study sample so that readers can gauge how well the study findings apply to their patients (external validity). Then present primary findings followed by any secondary and subgroup findings. Use tables and figures to demonstrate main characteristics of participants and major findings. Avoid redundancy between text and tables and figures.

Discussion: Consider structuring the discussion according to the following sequence.

Provide a brief synopsis of key findings, with particular emphasis on how the findings add to the body of pertinent knowledge.
Discuss possible mechanisms and explanations for the findings.
Compare study results with relevant findings from other published work. Briefly state literature search sources and methods (e.g., English-language MEDLINE search to Jan 2007) that identified previous pertinent work. Use tables and figures to help summarize previous work when possible.
Discuss the limitations of the present study and any methods used to minimize or compensate for those limitations.
Mention any crucial future research directions.
Conclude with a brief section that summarizes in a straightforward and circumspect manner the clinical implications of the work.

Acknowledgments TOP

Acknowledge only persons who have contributed to the scientific content or provided technical support. Authors should obtain written permission from anyone they wish to list in the Acknowledgments section. The corresponding author must also affirm that he or she has listed everyone who contributed significantly to the work in the Acknowledgments.

References TOP

Number references, using Arabic numerals in parentheses, in the order in which they first appear in the text. References cited in a table/figure should appear in numeric order relative to the first citation of the table/figure in the text. For example, if the last reference cited before the table/figure in question is mentioned as reference 14, and that table/figure contains 5 references that have not been cited, the references in the table/figure would be numbered 15 through 19. Reference citations in the text would then recommence with number 20.
Appendix material should not have separate reference sections. References that appear in both the text and the appendix should be numbered as they appear in the text. Any references that appear only in the appendix should be added consecutively to the end of the text reference list.
Use the reference style of the National Library of Medicine, including the abbreviations of journal titles.
List all authors when there are 6 or fewer; when there are 7 or more authors, list only the first 6 and add “et al.”
Do not use ibid. or op cit.
Include an “available from” note for documents that may not be readily accessible.
Cite symposium papers only from published proceedings.
When citing an article or book accepted for publication but not yet published, include the title of the journal (or name of the publisher) and the year of expected publication.
Include references to unpublished material in the text, not in the references (for example, papers presented orally at a meeting; unpublished work [personal communications, papers in preparation]), and submit a letter of permission from the cited persons to cite such communications (in general, avoid citations to unpublished scientific results).
Ensure that URLs used as references are active and available (the references should include the date on which the author accessed the URL) (see also Badgett ‘In Reply’).

Click here for sample references that conform to the style specified by the Uniform Requirements agreement.

Footnotes TOP

Use footnotes only on the title page and in tables. Do not use footnotes in the text. Footnote symbols, in the order in which they should be used, are *, †, ‡, §, ||, ¶, **, ††, ‡‡, and so on. Do not use numbers or letters.

Tables TOP

Number tables with Arabic numerals in the order in which they appear in the text. Tables that are meant as appendix material should be numbered as Appendix Table 1, Appendix Table 2, and so on. Use titles that concisely describe the content of the table so that a reader can understand the table without referring to the text. Tables may contain abbreviations that we do not permit in the text, but the table should contain a footnote that explains the abbreviation. Give the units of measure for all numerical data in a column or row. Place units of measure under a column heading or at the end of a side heading only if those units apply to all numerical data in the column or row.

Figures TOP

Number figures with Arabic numerals in the order in which they appear in the text. Figures that are meant as appendix material should be numbered as Appendix Figure 1, Appendix Figure 2, and so on. Each figure should have a figure legend that begins with a short title. Reduce the length of legends by using phrases rather than sentences. Explain all abbreviations and symbols on the figure, even if an explanation appears in the text. For pictures of histologic slides, give stain and magnification data at the end of the legend for each part of the figure. If no scale marker appears on the figure, give the original magnification used during the observation, not that of the photographic print.

Acknowledgements to original sources of borrowed material should use the wording specified by the original publisher of the material. If there is no specified wording, cite the authors, reference number, and the publisher. Letters of permission from the copyright holder must accompany submission of borrowed material.

Statistical Guidelines

Presentation
Issue	Notes
Percentages	Report percentages to one decimal place (i.e., xx.x%) when sample size is >=200. To avoid the appearance of a level of precision that is not present with small samples, do not use decimal places (i.e., xx%, not xx.xx%) when sample size is < 200.
Standard deviations	Use “mean (SD)” rather than “mean ± SD” notation. The ± symbol is ambiguous and can represent standard deviation or standard error.
Standard errors	Report confidence intervals, rather than standard errors, when possible.
P values	Report exact P values to two decimal places except when P<0.001, in which case “p<0.001” is sufficient.
“Trend”	Use the word trend when describing a test for trend or dose-response. Avoid the term trend when referring to P values near but not below 0.05. In such instances, simply report a difference and the confidence interval of the difference (if appropriate) with or without the P value.
Statistical software	Specify in the statistical analysis section the statistical software—version, manufacturer, and manufacturer’s location—used for analyses.
Cox models	When reporting the findings from Cox proportional hazards models: Do not describe hazard ratios as relative risks. Do report how the assumption of proportional hazards was tested, and what the test showed.
Descriptive tables	In tables that simply describe characteristics of 2 or more groups (e.g., Table 1 of a clinical trial): Report averages with standard deviations, not standard errors, when data are normally distributed. Report median (minimum, maximum) or median (25th, 75th percentile [interquartile range, or IQR]) when data are not normally distributed. Avoid reporting P values as there can be imbalance when p’s are not significant (because of small sample size) and balance when P values are significant (because of large sample size).
Tables reporting multivariable analyses	Authors sometimes present tables that compare one by one an outcome with multiple individual factors followed by a multivariable analysis that adjusts for confounding. If confounding is present, as is often the case, the one-way comparisons are simply intermediate steps that offer little useful information for the reader. In general, omit presenting these intermediate steps in the manuscript and do not focus on them in the Results or Discussion.
Tables and figures (general)	The following references give useful information about the design and format of informative tables and figures: Tufte ER. The Visual Display of Quantitative Information. Cheshire CT: Graphic Press; 1983, p 178. ISBN: 0961392142 Wainer, H. How to display data badly. The American Statistician 1984; 38:137-147. Google Scholar Wainer H. Visual Revelations: graphical tales of fate and deception from Napoleon Bonaparte to Ross Perot. New Jersey: Lawrence Erlbaum Associates, Inc.;1997. ISBN: 038794902X Pocock SJ, Clayton TC, Altman DG. Survival plots of time-to-event outcomes in clinical trials: good practice and pitfalls. Lancet 2002; 359:1686-89. PMID: 12020548 Also, follow a few simple rules of thumb: Avoid pie charts. Avoid simple bar plots or histograms that do not present measures of variability. Provide raw data (numerators and denominators) in the margins of meta-analysis forest plots. Depict numbers of people at risk at different times in survival plots. (see Pocock et al. above).

Multivariable Analysis TOP

Screening covariates

Approaches that select factors for inclusion in a multivariable model only if the factors are “statistically significant” in “bivariate screening” are not optimal. A factor can be a confounder even if it is not statistically significant by itself because it changes the effect of the exposure of interest when it is included in the model, or because it is a confounder only when included with other covariates.

Reference

Sun GW, Shook TL, Kay GL. Inappropriate use of bivariable analysis to screen risk factors for use in multivariable analysis. J Clin Epidemiol. 1996;49:907-16. PMID: 8699212

Model building

Authors should avoid stepwise methods of model building, except for the narrow application of hypothesis generation for subsequent studies. Stepwise methods include forward, backward, or combined procedures for the inclusion and exclusion of variables in a statistical model based on predetermined P value criteria. Better strategies than P value driven approaches for selecting variables are those that use external clinical judgment. Authors might use a bootstrap procedure to determine which variables, under repeated sampling, would end up in the model using stepwise variable selection procedures. Regardless, authors should tell readers how model fit was assessed, how and which interactions were explored, and the results of those assessments.

References

Collett D, Stepniewska K. Some practical issues in binary data analysis. Statist Med. 1999;18:2209-21. PMID: 10474134

Mickey RM, Greenland S. The impact of confounder selection criteria on effect estimation. Am J Epidemiol. 1989;129:125-37. PMID: 2910056

Steyerberg EW, Eijkemans MJC, Harrell FE, Jr., Habbema JDF. Prognostic modeling with logistic regression analysis: a comparison of selection and estimation methods in small data sets. Statist Med. 2000;19:1059-1079. PMID: 10790680

Steyerberg EW, Eijkemans MJC, Habbema DF. Stepwise selection in small data sets: a simulation study of bias in logistic regression analysis. J Clin Epidemiol. 1999;52:935-42. PMID: 10513756

Altman D, Andersen PK. Bootstrap investigation of the stability of a Cox regression model. Statist Med. 1989;8:771-83. PMID: 2672226

Mick R, Ratain MJ. Bootstrap validation of pharmacodynamic models defined via stepwise linear regression. Clin Pharmacol Ther. 1994;56:217-22. PMID: 8062499

Harrell FE, Jr, et al. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Statist Med. 1996;15:361-87. PMID: 8668867

Measurement Error

If several risk factors for disease are considered in a logistic regression model and some of these risk factors are measured with error, the point and interval estimates of relative risk corresponding to any of these factors may be biased either toward or away from the null value; the direction of bias is never certain. In addition to potentially biased estimates, confidence intervals of correctly adjusted estimates will be wider, sometime substantially, than naïve confidence intervals. Authors are encouraged to consult the references below for strategies to address this problem.

References

Rosner B, Spiegelman D, Willett WC. Correction of logistic regression relative risk estimates and confidence intervals for measurement error: the case of multiple covariates measured with error. Am J Epidemiol. 1990;132:734-45. PMID: 2403114

Carroll R. Measurement Error in Epidemiologic Studies. In Encyclopedia of Biostatistics. New York: John Wiley & Sons; 1998. ISBN: 0471975761.

Measures of Effect and Risk TOP

Clinically meaningful estimates

Authors should report results for meaningful metrics rather than reporting raw results. For example, rather than reporting the log odds ratio from a logistic regression, authors should transform coefficients into the appropriate measure of effect size, odds ratio, relative risk, or risk difference. Don’t give readers an estimate, such as an odds ratio or relative risk, for a one unit change in the factor of interest when a 1-unit change lacks clinical meaning (age, mm Hg of blood pressure, or any other continuous or interval measurement with small units). All estimates should reflect a clinically meaningful change, along with 95% confidence bounds.

Between-group differences

For comparisons of interventions (e.g., trials), focus on between- group differences, with 95% confidence intervals of the differences, and not on within-group differences. State the results using absolute numbers (numerator/denominator) when feasible. When discussing effects, refer to the confidence intervals rather than P values and point out for readers if the confidence intervals exclude the possibility of significant clinical benefit or harm.

Odds ratios and predicted probabilities

Authors often report odds ratios for multivariable results when the odds ratio is difficult to interpret or not meaningful. First, the odds ratio might overstate the effect size when the reference risk is high. For example, if the reference risk is 25% (odds = 0.33) and the odds ratio is 3.0, the relative risk is only 2.0. Statements such as “3-fold increased risk” or “3 times the risk” are incorrect. Second, readers want an easily understood measure of the level of risk (and the confidence intervals) for different groups of patients as defined by treatment, exposure, and covariates. Consider providing a table of predicted probabilities for each of the factors of interest, and confidence intervals of those predicted probabilities. Moreover, a multiway table that cross classifies predicted probabilities by the most important factor and then adjusts for the remaining factors will often be more meaningful than a table of adjusted odds ratios. Standard commercial software can produce predicted probabilities and confidence bounds.

Reference

Altman DG, Deeks JJ, Sackett DL. Odds ratios should be avoided when events are common. BMJ. 1998;317:1318. PMID: 9804732

Missing Data TOP

Missing variables

Always report the frequency of missing variables and how the analysis handled missing data. Consider adding a column to tables or a row under figures that makes clear the amount of missing data. Avoid using a simple indicator or dummy variable to represent a missing value. Replacing missing predictors with dummy variables or missing indicators generally leads to biased estimates.

References

Vach W, Blettner M. Biased estimation of the odds ratio in case-control studies due to the use of ad hoc methods or correcting for missing values of confounding variables. Am J Epidemiol. 1991;134:895-907. PMID: 1670320

Vach W, Blettner M. Missing data in epidemiologic studies. In Encyclopedia of Biostatistics. New York: John Wiley & Sons; 1998:2641-2654. ISBN: 0471975761

Greenland S, Finkle WD. A critical look at methods for handling missing covariates in epidemiologic regression analyses. Am J Epidemiol. 1995;142:1255-64. PMID: 7503045

Allison PD. Missing Data. Thousand Oaks, California: Sage Publications, Inc., 2002. ISBN: 0761916725

Missing Outcomes

Always report the frequency of missing outcomes and follow-up data; reasons and any patterns for the missing data; and how you handled missing data in the analyses. Do not use a last observation carried forward approach (LOCF) to address incomplete follow-up even if the original protocol prespecified that approach for handling missing data. LOCF approaches understate variability and result in bias. The direction of the bias is not predictable. Although the method of addressing missing data may have little import on findings when the proportion of missing data is small (e.g., <5%), authors should avoid using outdated or biased methods to address incomplete follow-up. Appropriate methods for handling missing data include imputation, pattern-mixture (mixed) models, and selection models. Application of these methods requires consideration of the patterns and potential mechanisms behind the missing data.

References

Fitzmaurice GM, Laird NM, Ware JH. Applied Longitudinal Analysis. New York; John Wiley & Sons:2004:chapter 14. ISBN: 0471214876

Molenberghs G, Verbeke G. Models for Discrete Longitudinal Data. New York: Springer;2005:chapters 26-32. ISBN: 0387251448

Longitudinal Analyses TOP

Consider using longitudinal analyses if outcome data were collected at more than 1 time point. With an appropriate model for longitudinal analysis, you can report differences within groups over time, differences between groups, and differences across groups of their within-group changes over time (usually the key contrast of interest). You can control for any confounding that might emerge, such as a difference in a variable (e.g., body weight) among those who remained in the study until completion. Longitudinal analysis options include a population averaged analysis (generalized estimating equations [GEEs], for example) that estimates the time by treatment interaction and adjusts variance for the repeated measures within individuals over time. Another option is a mixed effects model, with random effects for patient, and the estimate of interest being the time by treatment interaction. In choosing a model, consider whether any missing data are missing at random (i.e. “ignorable” missing data) or missing dependent on the observed data (i.e. informative missing data). In GEE analyses, missing data are assumed to be missing completely at random independent of both observed and unobserved data. In random coefficient analysis, missing data are assumed missing at random dependent on observed data but not on unobserved data.

Reference

Twisk JWR. Applied longitudinal data analysis for epidemiology: a practical guide. Cambridge University Press. New York 2003 ISBN: 0521819768

Specific Article Types

Specific Article Types: Original Research

Overview of Original Research Formats

Original research may be reported in a full-length article or a brief communication.

Full-length articles are reports of original research on the prevalence, causes, mechanisms, diagnosis, course, treatment, and prevention of disease.

Word limit for abstract: 275 words
Word limit for text: 3200 words (excluding Abstract and references)

Brief Communications are preliminary or limited results of original research studies, or are full reports of original research that can be conveyed in shortened form.

Word limit for abstract: 175 words
Word limit for text: 1500 words (excluding Abstract and references)

Controlled Trials TOP
Description: Reports of trials of interventions for the treatment, diagnosis, course, or prevention of disease. A trial may be reported in either a full-length article or a brief communication format. Recent examples
Title
Subtitle	For randomized trials, add the subtitle “A Randomized, Controlled Trial” to the full title of your manuscript. For example: “Effect of Increasing the Intensity of Implementing Pneumonia Guidelines: A Randomized, Controlled Trial”.
Abstract
Word limit	275 words
Structure	Background, Objective, Design, Setting, Patients, Intervention, Measurements, Results, Limitations, Conclusions (see Haynes, Hopewell).
Other	Specify where the trial is registered and the trial’s unique registration number at the end of the abstract (see Clinical Trials Registration). Also state the source of funding, if any.
Manuscript
Guidelines and checklists	All RCTs: CONSORT standards (see Moher, Hopewell) and extension for reporting adverse outcomes (see Ioannidis) Cluster RCTs: CONSORT standards for cluster RCTs (see Campbell) Herbal intervention RCTs: CONSORT Statement elaboration (see Gagnier) Nonpharmacologic RCTs: Consort extension (see Boutron) Noninferiority and equivalence RCTs: CONSORT Statement extension (see Piaggio)
Word limit	3200 words (excluding abstract and references)
Sections	Introduction, Methods, Results, and Discussion. Use the following methods section subheadings: Design Overview Setting and Participants Randomization and Interventions Outcomes and Follow-up Statistical Analysis
References	75 or fewer
Tables and figures	About 6 Include a CONSORT flow diagram.
Comments	Always end the introduction section with a clear statement of the study’s objectives or hypotheses. Identify the funding source for the study, and its role in the study’s design, conduct, and reporting. Put this information under the last subhead of the Methods section and title the subhead Role of the Funding Source. Confirm that the study was approved by an Institutional Review Board. If the study was not submitted to an Institutional Review Board, provide documentation that not seeking Institutional Review Board review for this type of study was in accordance with the policy of your institution.
Other
Protocol	Submit the trial protocol that was approved by the institutional review board and subsequent amendments. Make sure that these documents are dated appropriately.
Statistical analysis	Save and be prepared to submit statistical code and output from data analyses if the editors so request.
Data	To check or clarify analyses and findings, editors may ask researchers to provide the raw data for their studies during review or at any time up to 5 years after publication in Annals.

Clinical Trials Registration TOP

All clinical trials must be registered in a public registry prior to submission. We follow the trials registration policy of the International Committee of Medical Journal Editors (www.ICMJE.org) and consider only trials that have been appropriately registered before submission, regardless of when the trial closed to enrollment. Acceptable registries must meet the following ICMJE requirements: be publicly available, searchable, and open to all prospective registrants; have a validation mechanism for registration data; and be managed by a not-for-profit organization.

As defined by the ICMJE, a clinical trial is any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. A medical intervention is any intervention used to modify a health outcome, and includes but is not limited to drugs, surgical procedures, devices, behavioral treatments, and process-of-care changes. A trial must have at least 1 prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration. Nonrandomized trials are not exempt from the registration requirement if they meet the above criteria.

Observational Studies TOP
Description: Reports of cohort, case-control, and cross-sectional studies of the prevalence, causes, mechanisms, diagnosis, course, treatment, and prevention of disease.
Abstracts
Word limit	275 words
Structure	Background, Objective, Design, Setting, Patients, Measurements, Results, Limitations, Conclusions (see Haynes).
Manuscript
Guidelines and checklists	STROBE statement and checklist (See von Elm and Vandenbroucke)
Word limit	3200 words (excluding abstract and references)
Sections	Introduction, Methods, Results, and Discussion
References	75 or fewer
Tables and figures	About 6
Comments	Always end the introduction section with a clear statement of the study’s objectives or hypotheses. Identify the funding source for the study, and its role in the study’s design, conduct, and reporting. Put this information under the last subhead of the Methods section and title the subhead Role of the Funding Source. In the Methods section, state (if correct) that the study was approved by an Institutional Review Board. If the study was not submitted to an Institutional Review Board, provide documentation that not seeking Institutional Review Board review for this type of study was in accordance with the policy of your institution.
Other
Protocol	We encourage submission of the original study protocol.
Statistical analysis	Save and be prepared to submit statistical code and output from data analyses if the editors so request.
Data	To check or clarify analyses and findings, editors may ask researchers to provide the raw data for their studies during review or at any time up to 5 years after publication in Annals.


Diagnostic Test Studies TOP
Description: Reports of studies of the accuracy of diagnostic tests. Recent examples
Title
Title	Identify the article as a study of diagnostic accuracy somewhere in the Title.
Abstracts
Word limit	275 words
Structure	Background, Objective, Design, Setting, Patients, Measurements, Results, Limitations, Conclusions (see Haynes).
Manuscript
Guidelines and checklists	Consult STARD guidelines and checklist (see Bossuyt).
Word limit	3200 words (excluding abstract and references)
Sections	Introduction, Methods, Results, and Discussion.
References	75 or fewer
Tables and figures	About 6 Include a STARD flow diagram (see Bossuyt).
Comments	Always end the introduction section with a clear statement of the study’s objectives or hypotheses. Identify the funding source for the study, and its role in the study’s design, conduct, and reporting. Put this information under the last subhead of the Methods section and title the subhead Role of the Funding Source. Confirm that the study was approved by an Institutional Review Board. If the study was not submitted to an Institutional Review Board, provide documentation that not seeking Institutional Review Board review for this type of study was in accordance with the policy of your institution.
Other
Protocol	We encourage submission of the original study protocol.
Statistical analysis	Save and be prepared to submit statistical code and output from data analyses if the editors so request.
Data	To check or clarify analyses and findings, editors may ask researchers to provide the raw data for their studies during review or at any time up to 5 years after publication in Annals.


Cost-Effectiveness Studies TOP
Description: Reports of comparisons of the relative costs and benefits of two or more interventions intended to prevent, diagnose, or treat disease. Recent examples
Title
Subtitle	For studies of cost-effectiveness, identify the article as a cost-effectiveness analysis.
Abstracts
Word limit	275 words
Structure	Background, Objective, Design, Data Sources, Target Population, Time Horizon, Perspective, Interventions, Outcome Measures, Results of Base-Case Analysis, Results of Sensitivity Analysis, Limitations, Conclusions (see Haynes).
Manuscript
Guidelines and checklists	We recommend authors of these reports to include the elements suggested by published guidelines (see Siegel, also Philips, Sculpher, Weinstein.)
Word limit	3200 words (excluding abstract and references)
Sections	Introduction, Methods, Results, and Discussion
References	75 or fewer
Tables and figures	About 6
Comments	Always end the introduction section with a clear statement of the study’s objectives or hypotheses. Identify the funding source for the study, and its role in the study’s design, conduct, and reporting. Put this information under the last subhead of the Methods section and title the subhead Role of the Funding Source. Confirm that the study was approved by an Institutional Review Board. If the study was not submitted to an Institutional Review Board, provide documentation that not seeking Institutional Review Board review for this type of study was in accordance with the policy of your institution.
Other
Statistical analysis	Save and be prepared to submit statistical code and output from data analyses if the editors so request.
Data	To check or clarify analyses and findings, editors may ask researchers to provide the raw data for their studies during review or at any time up to 5 years after publication in Annals.

Specific Article Types: Reviews

Systematic Reviews and Meta-analyses TOP
Description: Reviews that systematically find, select, critique, and synthesize evidence relevant to well-defined questions about diagnosis, prognosis, or therapy. Recent examples
Title
Subtitle	For studies that are meta-analyses or systematic reviews, add that descriptor as the subtitle at the end of the title.
Abstracts
Word limit	275 words
Structure	Background, Purpose, Data Sources, Study Selection, Data Extraction, Data Synthesis, Limitations, Conclusions (see Mulrow, Haynes).
Manuscript
Guidelines and checklists	For meta-analyses of randomized, controlled trials, follow PRISMA reporting guidelines and checklist. For meta-analyses of observational studies in epidemiology, follow MOOSE reporting guidelines and checklist.
Word limit	3500 words (excluding abstract and references)
Sections	Introduction, Methods, Results, and Discussion. The methods section subheadings should be: Data Sources and Searches Study Selection Data Extraction and Quality Assessment Data Synthesis and Analysis
References	75 or fewer
Tables and figures	4 or fewer Include a flow diagram that depicts search and selection processes, and evidence tables.
Comments	Always end the introduction section with a clear statement of the study’s objectives or hypotheses. For studies that have numerical data and use statistical inference, include a section under Methods that describes the methods and specific statistical software used for the statistical analysis.


Narrative Reviews TOP
Description: Narrative reviews are especially suitable for describing cutting-edge and evolving developments, and discussing those developments in light of underlying theory. Recent Examples
Abstracts
Word limit	275 words
Unstructured
Manuscript
Guidelines	Consult Annals editors’ guidelines for narrative reviews (see Editors).
Word limit	3500 words (excluding abstract and references)
Tables and figures	4 or fewer
References	75 or fewer
Comments	Include a box listing 3 to 7 take-home points that link back to the original questions that the review set out to answer.

Specific Article Types: Letters

Clinical Observations TOP
Description: Clinical Observations may be original research presented in a research letter format or case reports or series. If an author believes that the case report or case series is important enough to warrant publication as a Brief Communication (up to 1500 words), they should contact the Editor for advice about which format to use. (Of note, readers who wish to comment on published articles should use the Rapid Response mechanism.)
Manuscript
Guidelines and checklists	If you report an adverse drug reaction (ADR), follow reporting guidelines for ADRs (see Edwards).
Word limit	600 words (excluding references)
Sections	Background, Objective, Methods and Findings (or Case Report, as applicable), Discussion, and References
References	5 or fewer
Tables and figures	Maximum of 1 table or figure
Comments	Maximum of 5 authors


Rapid Responses TOP
Description: "Letter to the editor" in response to a published article.
Abstracts
Abstract	None
Manuscript
Word limit	400 words (excluding references)
References	5 or fewer
Tables and figures	None
Authors	Maximum of 3 authors
Other details	Responses should be submitted within 1 month of publication of an article. Responses are usually reviewed and posted 24 to 72 hours after submission. Authors’ names, e-mail addresses, institutional affiliations and any conflicts of interest (including financial, employment, consultancies, grants or patents pending or received, honoraria, and/or expert testimony) will be posted with the Response. Responses are not typically edited, so careful attention to spelling and grammar is advised. Responses that are not directly related to a published article; that duplicate points similar to those of already posted comments; or that are characterized by profanity; offensive, abusive, or libelous language; or personal attacks will not be posted. The editors will select some of the Responses for print publication in Annal. Editors will ask authors of the original article to respond to the rapid responses selected for print publication. Authors of material selected for print publication will be asked to submit copyright forms and conflict of interest disclosures. Rapid Responses may be submitted online. Click the “Send comment/rapid response letter” link in the green box to the right of the article you want to respond to, as shown in the image to the right.

Specific Article Types: Other

Abroad TOP
Description: Reports on health care in countries other than the United States. Recent examples
Abstracts
Word limit	175 words
Structure	Unstructured
Manuscript
Word limit	2000 words (excluding abstract and references)
References	10 or fewer
Tables and figures	Limit is 1


Academia and Clinic TOP
Description: Descriptions and evaluations of innovations in medical education, training, and research methodology. Academia and Clinic may take a variety of forms including original research, narrative or systematic reviews, guidelines, or points of view (perspectives). Narrative reviews are especially suitable for describing cutting-edge and evolving developments, and discussing those developments in light of underlying theory. Systematic reviews are especially suitable for critiquing and summarizing a body of evidence relevant to focused questions about diagnostic, prognostic, or therapeutic clinical practices. For further instructions, please click one of the links above. Recent examples
Abstracts
Word limit
Structure	Unstructured or structured depending on article type
Manuscript
Word limit	1500-4000 depending on article type (excluding abstract and references)
References	No limit
Tables and figures	No limit
Other
Statistical analysis	Save and be prepared to submit statistical code and output from data analyses if the editors so request.
Data	To check or clarify analyses and findings of articles with original data, editors may ask researchers to provide the raw data for their studies during review or at any time up to 5 years after publication in Annals.


Ad Libitum TOP
Description: Poetry. Recent examples
Manuscript
Maximum length	80 lines


Editorials TOP
Description: Commentary on current topics or on papers published elsewhere in the issue. Recent examples
Abstracts
Abstract	None
Manuscript
Word limit	1000 words (excluding references)
References	20 or fewer
Tables and figures	Limit is 1
Comments	Most editorials published in Annals are solicited by the Editors.


Clinical Guidelines and Position Papers TOP
Description: Summaries of official or consensus positions on issues related to clinical practice, health care delivery, or public policy. Recent examples
Abstracts
Word limit	275
Structure	Unstructured
Manuscript
Guidelines and checklists	We expect authors of reports in one of these categories to include the elements suggested by the guidelines (see GRADE, Shiffman).
Word limit	4000 words (excluding references)
Comments	Include descriptions of procedures used to formulate guideline recommendations and a bibliography of sources upon which the guideline recommendations are based


History of Medicine TOP
Description: Essays, reports, or biographic sketches on the evolution of medicine. Recent examples
Abstract
Word limit	275 words
Structure	Unstructured
Manuscript
Word limit	3200 words (excluding abstract and references)
References	No limit
Tables and figures	No limit


Improving Patient Care TOP
Description: Reports of original research, reviews, and perspectives on improving the quality of patient care and avoiding medical errors. Recent examples
Abstract
Word limit
Structure	Unstructured or structured depending on article type
Manuscript
Word limit	1500-4000 depending on article type
References	No limit
Tables and figures	No limit
Other
Statistical analysis	Save and be prepared to submit statistical code and output from data analyses if the editors so request.
Data	To check or clarify analyses and findings of articles with original data, editors may ask researchers to provide the raw data for their studies during review or at any time up to 5 years after publication in Annals.


In the Balance TOP
Description: Views on unsettled questions of diagnosis and treatment, particularly questions arising on common, important clinical problems. Recent examples
Abstracts
Word limit	175 words
Structure	Unstructured
Manuscript
Word limit	1500 words (excluding abstract and references)
References	20 or fewer bibliographic references
Tables and figures	No limit
Comments	Usually includes 2 papers presenting differing views. May be accompanied by an editorial; solicited by the editors.


Medicine and Public Issues TOP
Description: Papers on the economic, ethical, sociologic, or political environment in medicine. Recent examples
Abstracts
Word limit	175 words
Structure	Unstructured
Manuscript
Word limit	2500 words (excluding abstract and references)
References	No limit
Tables and figures	No limit


On Being A Doctor/On Being A Patient TOP
Description: Short essays on illuminating experiences of physicians or patients. Physicians, patients, and their families are invited to submit essays. Authors should specify in a cover letter whether the essay is nonfiction, fiction, or a fictionalized account of true events. If the essay is nonfiction, we ask that the authors mask the identity of people. In addition, the editors feel it is important for authors to show the manuscript to those described in the essay and to obtain their permission to publish the material. Annals does not require signed permission from the subjects of essays, but we do require the authors to state in writing whether they obtained the subjects’ permission. If the author has not obtained permission, he or she should explain the reasons for its absence in a cover letter that accompanies the manuscript. We publish nonfiction material that does not have the subject’s permission at the editors’ discretion. Recent examples
Manuscript
Word limit	1500 words


Personae TOP
Description: Photographs that capture the personality of people (adults) in the context of their daily lives.
Comment	Submit vertically oriented black-and-white photographs. If accepted, the photographs must be re-submitted on a compact disk in JPG or TIF format at print-quality resolution (i.e., no less than 400 pixels at 2 inches wide, preferably at least 600 pixels at 2 inches wide). The photographer must obtain written permission from the subject(s); photographs are not returned.


Perspective TOP
Description: Essays representing opinions, presenting hypotheses, or considering controversial issues.
Abstracts
Word limit	175 words
Structure	Unstructured or structured depending on article type
Manuscript
Word limit	1500 words (excluding abstract and references)
References	20 or fewer bibliographic references
Tables and figures	About 2 tables or figures

Manuscript Processing

Fast-Track Publication

We will consider manuscripts for expedited review and early publication if they are of very high quality, if they have findings that are likely to affect practice immediately, and if rapid publication would probably minimize adverse patient care consequences. We will give particular priority for fast-tracking to large clinical trials. If authors think that their manuscript warrants fast-tracking and expedited review, they should contact Senior Deputy Editor Dr. Cynthia Mulrow (cmulrow@acponline.org) or Executive Deputy Editor Dr. Barbara Turner (baturner@mail.acponline.org) and provide an electronic version of the manuscript, the protocol and registry identification number, and a justification for expedited review.

Within 48 hours, 2 editors will judge whether a manuscript is eligible for expedited review. The review process takes approximately 3 weeks. The author will receive suggestions for revision no later than 1 month after receipt of the manuscript, and return of the revised manuscript is expected within 2 weeks. Accepted manuscripts are scheduled for publication immediately. In most instances, fast-track manuscripts are published electronically at www.annals.org within 2 weeks of acceptance, with print publication 2 months later.

Acknowledgement of Receipt TOP

We acknowledge all manuscripts and assign each a unique, confidential manuscript number. We provide all authors with instructions for checking the status of the manuscript online. To check the status of your manuscript online, click here.

Internal Review by Editors and Peer Review TOP

At least 1 Editor and 1 Associate Editor read each manuscript. Together, they decide whether to send the paper to outside reviewers. If a paper is rejected without external review, authors are notified electronically within 1 to 2 weeks of receipt. We retain copies of rejected manuscripts for 60 days, after which we delete them from our system.

We send about 50% of submitted papers for peer review, usually to at least 2 reviewers. The Editors select reviewers from an electronic database of about 13 000 reviewers. We do not send a manuscript to a reviewer who is affiliated with the same institution as any of the authors. We ask reviewers to declare potential conflicts of interest and to decline the opportunity to review if they think that a close personal or professional relationship with any of the authors could lead to a review that would be different than if no such relationship existed. If peer reviewers do not know whether a particular situation merits disqualification from the review process, they should contact the editors who will advise them about recusal on a case by case basis. Authors may list individuals that they do not want to be a reviewer, but must justify their requested exception in the cover letter.

Editors and associate editors discuss many of the papers that are peer reviewed at a weekly manuscript conference. Editors recuse themselves from discussing manuscripts and avoid participation in decisions about manuscripts if they have a close personal or professional relationship with any of the authors.

Acceptance or Rejection and Criteria for Editorial Decisions TOP

Annals can publish only a fraction of all papers submitted each year. In recent years, 13% of all submissions and 7% of Articles and Brief Communications were accepted. Editors judge the potential importance and newness of material and consider scientific rigor using established methodological criteria (See ACP Journal Club Basic Criteria at www.acpjc.org). They select manuscripts based on the strength of the paper compared with other papers under review, the need for Annals to represent a balanced picture of important advances in internal medicine, and the number of accepted papers in the paper’s category and topic area. Almost all papers that we accept require some editorial or statistical revision before publication. Of note, to check or clarify analyses and findings, editors may ask researchers to provide the raw data for their studies during review or at any time up to 5 years after publication in Annals.

We send the reviewers’ comments to authors whether or not we accept the article. On occasion, we reject an article but invite a resubmission that addresses specific concerns of the editors. We aim to accept a high percentage (at least three quarters) of these articles that we re-invite, and we specify conditions that the authors must meet before we will accept a re-invited manuscript. Upon resubmission, we assign reinvited manuscripts a new unique, confidential manuscript number. We determine whether to send the reinvited manuscript for repeated external peer review or internal editorial and statistical review on a case-by-case basis.

Submitting an Appeal TOP

Authors who think that their manuscripts were rejected wrongly may e-mail an appeal letter to the editor who handled the manuscript. The letter should detail the author’s concern and state how the manuscript could be revised or clarified to address key problems mentioned by editors and reviewers. The editors expect appeals infrequently and do not reverse their original decisions often. Many rejections involve editors’ judgments of priority that authors usually cannot address through an appeal. Editors only consider appeals that are submitted within 2 months of the manuscript’s rejection and consider appeals only once. Upon receiving the appeal, editors may confirm their decision to reject the manuscript, invite a revised manuscript, or seek additional peer review or statistical review of the original manuscript.

Manuscript Publication

Postacceptance Copy Editing TOP

All accepted manuscripts are subject to copy editing to improve clarity and achieve consistency of style and formatting of journal content. Authors will have the opportunity to approve revisions made during the copy editing process. Editors will work with authors to arrive at agreement when authors do not find the revisions acceptable, but Annals reserves the right not to publish a manuscript if discussion with the author fails to reach a solution that satisfies the editors.

National Institutes of Health-Funded Research Articles TOP

The American College of Physicians, publisher of Annals, supports authors’ adherence to the NIH Public Access Policy. Authors of articles reporting NIH-funded studies may submit to PubMedCentral (PMC) a document that contains the “accepted manuscript.” “Accepted manuscript” refers to the prepublication version for which Annals has issued a notice of final acceptance.

Neither the American College of Physicians nor Annals of Internal Medicine can assume responsibility for prepublication versions of articles. To limit confusion about multiple versions of article content, the “accepted version” submitted to PMC should prominently display the following disclaimer immediately following the title:

“This is the prepublication, author-produced version of a manuscript accepted for publication in Annals of Internal Medicine. This version does not include post-acceptance editing and formatting. The American College of Physicians, the publisher of Annals of Internal Medicine, is not responsible for the content or presentation of the author-produced accepted version of the manuscript or any version that a third party derives from it. Readers who wish to access the definitive published version of this manuscript and any ancillary material related to this manuscript (e.g., correspondence, corrections, editorials, linked articles) should go to www.annals.org or to the print issue in which the article appears. Those who cite this manuscript should cite the published version, as it is the official version of record.”

Authors are responsible for informing PMC that it should not make the accepted manuscript publicly available in the PMC repository until 6 months after the date of publication in Annals of Internal Medicine.

Authors should not submit copies of the final published version (e.g., PDF or html versions copied from www.annals.org) to PMC. This action would violate the American College of Physicians copyright.

PubMedCentral Submission TOP
Article version	Definition	Copyright owner	Annals permits author to send to PubMedCentral
Final accepted	Author manuscript accepted for publication by Annals, before final editing and formatting	Annals	Yes
Final published	Article published in Annals, with final editing and formatting	Annals	No

Free Access Policy TOP

Annals gives free access to the following content:

Articles published early at www.annals.org prior to publication in the print version of Annals
Articles that the editors determine to be of immediate importance to the public
Clinical Guidelines and Summaries for Patients (use the advanced search page to search Annals for only these articles)
PDFs of all articles from 1999 to 6 months before the current issue
Full text (HTML) of all articles from 1993 to 1998 (these issues do not contain PDFs of articles)
Any article if the user is:
- An Annals subscriber
- A member of the American College of Physicians
- From a country in the HINARI initiative or in the World Bank’s list of “Lower-income economies”

Prepublication Policy TOP

Annals publishes on the first and third Tuesday of each month. Annals sends advance copies of the journal to members of the news media the week before publication. Reporters may not publish stories based on this information until 5:00 p.m. (U.S. Eastern time) of the day before the date of publication of an issue. Authors are free to discuss their research with representatives of the media but should not distribute copies of papers accepted for publication in Annals. They should consent to be interviewed only if the reporter agrees to abide by the embargo and will not publish until after the embargo period.

Providing copies of manuscripts or detailed information to media, manufacturers, or government agencies of scientific information described in a paper or a Letter to the Editor that has been accepted but not yet published violates the policies of Annals and many other journals. Annals may grant an exception to this rule when the paper or letter describes major therapeutic advances, public health hazards (such as serious adverse effects of drugs, vaccines, other biological products, or medical devices), or reportable diseases. Prepublication disclosure as part of sworn testimony before legislative or judiciary bodies may also be acceptable. Authors should discuss any possible prepublication disclosure with the Editors in advance and obtain their agreement.

Scheduling of Accepted Papers and Proofs TOP

We notify authors when they can expect to receive proofs. Authors who think they may not be able to examine proofs within 48 hours of receiving them should call the Editorial Production Supervisor (215-351-2633) to designate a colleague who will review proofs.

Ordering Reprints TOP

We send a form for ordering reprints to authors when we send the proofs of the edited manuscript. If the author does not return the form to the address listed on the form, we will not order reprints. Third parties who wish to order reprints of published articles may do so by contacting Helen Canavan (hcanavan@acponline.org).

Authorship Issues

Authorship: Criteria and Policy

Authorship implies accountability. Listed authors must have contributed directly to the intellectual content of the paper, and the corresponding author should list the specific contributions of all authors in the appropriate section of the Authors’ Form. Authors should meet all of the following criteria, thereby allowing persons named as authors to accept public responsibility for the content of the paper.

Conceived and planned the work that led to the article or played an important role in interpreting the results, or both.
Wrote the paper and/or made substantive suggestions for revision.
Approved the final version.

Holding positions of administrative leadership, contributing patients to a study, and collecting and preparing the data for analysis, however important to the research, are not, by themselves, criteria for authorship. The manuscript should note people who made substantial, direct contributions to the work but did not meet the criteria for authorship in the Acknowledgments section, and should provide a brief description of their contributions.

Medical writers and industry employees can be legitimate contributors, and their roles, affiliations, and potential conflicts of interest should be described when submitting manuscripts (Daskalopoulou, Jacobs). These writers should be acknowledged on the byline or in the Acknowledgments section in accord with the degree to which they contributed to the work reported in the manuscript. The editors consider failure to acknowledge these contributors ghostwriting, which is contrary to Annals' editorial policy.

Authorship: Declaration Processes TOP

All authors of papers accepted for publication must electronically sign a form affirming that they have met the criteria for authorship, have agreed to be authors, and are aware of the terms of publication. We request that authors complete these forms when we suggest revisions to manuscripts. We do not require them when manuscripts are initially submitted. We also request that authors provide written permission from the individuals that they wish to list in the Acknowledgments section when we suggest revisions to manuscripts.

The corresponding author will serve as the first contact for all communication about manuscripts submitted to Annals, and it is this person’s responsibility to share all Annals communication with all of the authors. In addition, it is the corresponding author’s responsibility to respond to any questions regarding the integrity of the work, including but not limited to requests for study protocols or trial registry information, study data, and documentation of institutional review board approval. If the list of authors changes between submission and final acceptance of an article, it is the corresponding author’s responsibility to explain the changes to the editors in writing and to obtain written documentation that all of the authors (including deleted authors) approve of the author changes.

All authors, except U.S. government employees whose work was done as part of their official duties, must transfer copyright to the American College of Physicians, publisher of Annals. Transfer of copyright signifies transfer of rights for print publication; electronic publication; production of reprints, facsimiles, microfilm, or microfiche; or publication in a language other than English. We usually grant permission on request and without charge when authors ask to use portions of their work published in Annals for limited educational purposes and in other scholarly publications.

Conflict of Interest: Definition and Policy TOP

Conflict of interest exists when an author, editor, or peer reviewer has a competing interest that could unduly influence (or be perceived to do so) his or her responsibilities in the publication process. The potential for an author’s conflict of interest exists when he or she (or the author’s institution or employer) has personal or financial relationships that could influence (bias) his or her actions. These relationships vary from those with negligible potential to influence judgment to those with great potential to influence judgment. Not all relationships represent true conflict of interest. Conflict of interest can exist whether or not an individual believes that the relationship affects his or her scientific judgment.

Authors, editors, and peer reviewers must state explicitly whether potential conflicts do or do not exist. Academic, financial, institutional, and personal relationships (such as employment, consultancies, close colleague or family ties, honoraria for advice or public speaking, service on advisory boards or medical education companies, stock ownership or options, paid expert testimony, grants or patents received or pending, and royalties) are potential conflicts of interest that could undermine the credibility of the journal, the authors, and science itself.

Authors, editors, and peer reviewers must disclose their primary academic and institutional affiliations and all financial relationships that could be viewed as presenting a potential conflict of interest. These include, but are not limited to, any financial relationship that involves conditions or tests or treatments discussed in the manuscript and alternatives to the tests or treatments for those conditions. If persons are uncertain, they should err on the side of full disclosure. Disclosure of these relationships is essential not only for original research articles but also for editorials, letters, commentary, and review articles. Annals publishes author’s conflict of interest disclosures and discloses editor’s financial and academic relationships. Annals avoids publishing editorials, reviews, and guidelines authored by individuals with potential financial conflicts of interest but considers each such manuscript on a case-by-case basis.

Conflict of Interest: Disclosure Processes TOP

At the time of manuscript submission, Annals of Internal Medicine requires corresponding authors to summarize all authors’ conflict of interest disclosures. (We also require conflict of interest disclosures from members of panels that help formulate consensus or guideline recommendations, even if those contributors are not named authors on the consensus or guideline statement.) We provide the summary information collated by the corresponding author to editors and peer reviewers. If editors later invite the authors to revise a manuscript after peer review, we ask each author, including the corresponding author, to individually complete online Conflict of Interest Disclosure Statements. Relationships that we prompt authors to report include most of those mentioned above. We require reporting of the relationships if they occurred within the following time frames: a) during the year preceding the start of the development of the work reported in the manuscript up through acceptance for publication or b) during the five year period preceding acceptance for publication if this time frame is longer than the time frame described in a. We also require reporting any pertinent pending grants and drug approval or patent applications expected within 1 year following the manuscript acceptance date. At the time of manuscript acceptance, we ask authors to confirm and update, if necessary, their disclosure statements.

As part of the initial submission process, we also ask the corresponding author to attest that the authors had access to all the study data, take responsibility for the accuracy of the analysis, and had authority over manuscript preparation and the decision to submit the manuscript for publication. We do not consider an article unless the corresponding author makes this attestation on behalf of the authors. In addition, in the Methods section of the text, authors must state the funding source for the work and describe the role(s) of the funding organization in the design of the study; the collection, analysis, and interpretation of the data; and the decision to approve publication of the finished manuscript. If the funding source had no such involvement, the authors should state that.

Conflict of Interest: Investigation Processes TOP

Readers who believe that authors of articles published in Annals have neglected to disclose potential conflicts of interest should notify the journal about their concerns by either submitting a “rapid response” using the electronic system that is available for all published articles or contacting the editors in writing. Either form of communication should include the following information: name and contact information of person raising the concern, author’s name, title of article, nature of the relationship that the readers believe the authors failed to disclose including the company name if pertinent, and a description of how they became aware of the relationship. Readers should be aware that concerns raised in a rapid response are available not only to the editors but also to the authors and to other readers. Because erroneous allegations can harm the reputation of those named, those who raise such concerns should do so only after carefully checking to be sure the relationship they have identified is correct and is one that Annals policy requires authors to report.

The editors will respond to concerns about failure to disclose potential conflicts of interest by promptly investigating the potential conflict using publicly available means (e.g., internet searches, searching company and university web sites, examination of disclosures included in other published articles) and by asking the relevant authors for information about the matter. We will also alert all co-authors of the relevant manuscript about the concern and ask them to confirm their own conflict disclosures. The editors will directly notify the reader who raised the concern about the outcome of the investigation as soon as it is complete. If the editors verify that there was an undisclosed conflict of interest, Annals will publish a correction in the print journal and on www.annals.org that will be electronically linked to the relevant article.

Research/Publication Ethics

Confidentiality

The staff at Annals keeps author correspondence confidential, unless it is intended for publication (e.g., as a rapid response or letter to the editor). We also ask that authors and reviewers keep editorial correspondence confidential, and that authors refrain from sharing either the correspondence itself or the essence of its content with individuals who are not their collaborators. We ask authors to maintain this confidentiality about correspondence both before and after any final publication of their manuscript. Maintaining such confidentiality helps ensure that editors can offer advice that is in the best interests of authors’ papers without concern for how it might be considered or used by others.

Duplicate Publication or Submission

We ask that authors give full details on any possible previous or duplicate publication of any content of the manuscript in a cover letter. Previous publication of a small fraction of the content of a manuscript does not necessarily preclude its being published in Annals, but the Editors need information about previous publication when deciding how to use space in the journal efficiently; they regard authors’ failure to disclose possible prior or concurrent publication as a breach of scientific ethics (see Annals Policy on Prepublication Release of Information). We usually do not consider abstracts, posters, monographs, or detailed technology reports as duplicate prior publications that preclude submission. We usually deem other duplicative material (e.g., articles, reviews, perspectives) that is submitted, in press, or published in another peeryreviewed, easily accessible journal or source (e.g., The Cochrane Library) as prior work that precludes publication in Annals. Please attach a copy of any document that might be considered a previous publication at initial submission. If at any time the author submits to another journal a manuscript or Letter to the Editor that is under review by Annals, the author must inform the Annals Editors.

IRB Approval and Consent TOP

Research that involves human participants includes investigations that use only human blood, tissue, or medical records. The authors must confirm review of the study by the appropriate institutional review board or affirm that the protocol is consistent with the principles of the Declaration of Helsinki (see World Medical Association). If the authors did not obtain institutional review board approval before the start of the study, they should so state and explain the circumstances. If the study was exempt from review, the authors must state that such exemption complied with the policy of their local institutional review board. They should affirm that study participants gave their informed consent or state than an institutional review board approved conduct of the research without explicit consent from the participants. If patients are identifiable from illustrations, photographs, pedigrees, case reports, or other study data, the authors must submit the release form for each such individual (or copies of the figures with the appropriate release statement) giving permission for publication with the manuscript. Consult the Research section of the American College of Physicians Ethics Manual for further information.

Reproducible Research TOP

To encourage transparency and reproducible research (Peng, Domenici, Zeger), Annals will publish a statement with every original research article (Article or Brief Communication) indicating the authors willingness to share the following items with the public:

Study protocol (original and amendments)
Statistical code used to generate results
Dataset from which the results were derived

Annals does not require the sharing of these items but we do require authors to state their willingness to share, and any conditions for sharing. Access to these items may range from completely unrestricted (e.g., free availability of all the items via posting on an open-access Web site) to restricted (e.g., availability of certain portions of the items to approved individuals through written agreements with the author or research sponsor).

Scientific Misconduct TOP

In addition to breaches in procedures related to human subjects, research misconduct includes issues related to the fabrication or falsification of data, plagiarism, theft of ideas, duplicate publication, misrepresentation of author contributions, and failure to disclose potential financial conflicts of interest. Should the Editors suspect research misconduct related to manuscripts submitted for review, the journal reserves the right to notify and forward the submitted manuscript to the chief executive officer and/or dean of the sponsoring institution, the funding institution, or other appropriate authority for investigation. Annals recognizes the responsibility to notify the appropriate authorities but does not undertake the actual investigation or make determinations of misconduct. The editors will notify the authors of the journal’s intention to report a suspicion of research misconduct.

References

Badgett B, Berkwits M, Mulrow C. Scholarship erosion [Editors’ response to letter]. Available at www.annals.org/cgi/eletters/142/5/389.

Bailar JC 3rd, Mosteller F. Guidelines for statistical reporting in articles for medical journals. Amplifications and explanations. Ann Intern Med. 1988;108:266-73. [PMID: 3341656] Medline

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Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med. 2003;138:W1-12.[PMID:12513067] Medline - Annals.org

Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC; Standards for Reporting of Diagnostic Accuracy. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy. Clin Chem. 2003;49:1-6. [PMID: 12507953] Medline

Isabelle Boutron, MD, PhD; David Moher, PhD; Douglas G. Altman, DSc; Kenneth F. Schulz, PhD, MBA; Philippe Ravaud, MD, PhD, for the CONSORT Group Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration. Ann Intern Med. 2008;148:295-309. Annals.org

Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328:654-5. [PMID: 15031246] Medline

Cook DJ, Mulrow CD, Haynes RB. Systematic reviews: synthesis of best evidence for clinical decisions. Ann Intern Med. 1997;126:376-80. [PMID: 9054282] Medline - Annals.org

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Appendix

Sample References

Journals

1. Standard article (List all authors when there are 6 or fewer; when there are 7 or more authors, list only the first 6 and add “et al.”)

Vega KJ, Pina I, Krevsky B. Heart transplantation is associated with an increased risk for pancreatobiliary disease. Ann Intern Med. 1996;124:980-3.

2. Corporate author

Clinical exercise stress testing. Safety and performance guidelines. The Cardiac Society of Australia and New Zealand. Med J Aust. 1996;164:282-4.

3. Supplement

Shen HM, Zhang QF. Risk assessment of nickel carcinogenicity and occupational lung cancer. Environ Health Perspect 1994;102(Suppl 1):275-82.

4. Special format (also applies to abstracts and editorials)

Enzensberger W, Fischer PA. Metronome in Parkinson’s disease [Letter]. Lancet. 1996;347:1337.

Books

List all authors or editors when 6 or fewer; when there are 7 or more authors, list only the first 6 and add “et al.”

1. Author

Ringsven MK, Bond D. Gerontology and Leadership Skills for Nurses. 2nd ed. Albany, NY: Delmar; 1996.

2. Editors

Norman IJ, Redfern SJ, eds. Mental Health Care for Elderly People. New York: Churchill Livingstone; 1996.

3. Chapter in a book

Phillips SJ, Whisnant JP. Hypertension and stroke. In: Laragh JH, Brenner BM, eds. Hypertension: Pathophysiology, Diagnosis, and Management. 2nd ed. New York: Raven Pr; 1995:465-78.

4. Published proceedings paper

Bengtsson S, Solheim BG. Enforcement of data protection, privacy and security in medical informatics. In: Lun KC, Degoulet P, Piemme TE, Rienhoff O, eds. MEDINFO 92. Proceedings of the 7th World Congress on Medical Informatics; 6-10 September 1992; Geneva, Switzerland. Amsterdam: North-Holland; 1992:1561-5.

Other Citations in Reference List

1. In press (must have journal title)

Leshner AI. Molecular mechanisms of cocaine addiction. N Engl J Med. 1996; [In press].

2. Magazine article

Roberts JL. Villain or victim? Newsweek. 1996;4 Nov:40-1.

In-Text Citations of Unpublished Material (to be placed within parentheses)

1. Personal communication

(Strott CA, Nugent CA. Personal communication)

2. Unpublished papers

(Lerner RA, Dixon FJ. The induction of acute glomerulonephritis in rats. In preparation)

(Smith J. New agents for cancer chemotherapy. Presented at the Third Annual Meeting of the American Cancer Society, 13 June 1983, New York)

Citations of Electronic References

Cisler S. MediaTracks. Public Access Comput Syst Rev [serial on-line] 1990;109-15. Accessed at Public Access Computer Systems Forum PACS-L at www.pubaccess.com on 29 November 1997.

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