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Information for Authors

The American Journal of Kidney Diseases (AJKD) serves clinicians and scientists who treat and investigate kidney disease and associated conditions. AJKD is dedicated to providing high-quality, clinically relevant information in the form of original research articles, case reports, narrative reviews, editorials, and features.

CATEGORIES OF ARTICLES

AJKD welcomes manuscripts in the categories listed below. Authors should follow the general guidelines provided.

Original Investigations evaluate pathogenesis and treatment of kidney disease and hypertension, acid-base and electrolyte disorders, dialysis therapies, and kidney transplantation. AJKD only considers manuscripts that focus on clinical research. Studies that focus on laboratory measurements are acceptable only if they are directly linked to measurements or outcomes in humans. For clinical trials, AJKD requires registration in a public trials registry; more information about the clinical trial registration policy is provided in the Editorial Policies section of the AJKD website (www.ajkd.org).

An Original Investigation includes a structured abstract and is limited to 3,500 words (excluding abstract, references, acknowledgements, tables, and figure legends). Criteria for review will include validity, originality, and clinical importance. A list of study designs follows; where available, flowcharts and checklists are provided in the Appendix.

i. Clinical Trial: A clinical trial is an experimental study that assesses the effect of an intervention or compares the effects of 2 or more interventions. Reporting guidelines vary according to the design:

o Randomized Controlled Trial (RCT)

The CONSORT Flowchart should be consulted for reporting participant flow through enrollment, allocation, follow-up, and analysis. Other guidelines depend upon the trial’s design and are listed below.

- Parallel Group Design

The CONSORT Parallel Group Design Checklist should be used.

- Cluster-Randomized Trial

The CONSORT Cluster-Randomized Trial Checklist should be used.

- Noninferiority and Equivalence Randomized Trial

The CONSORT Noninferiority and Equivalence Randomized Trial Checklist should be used.

- Herbal Medicine Interventions

The CONSORT RCT of Herbal Medicine Interventions Checklist should be used.

Note: If appropriate, authors should also consult the CONSORT Checklist for Reporting of Harms in RCTs.

o Nonrandomized Trial for Evaluation of Behavioral and Public Health Interventions

The TREND Checklist should be consulted.

ii. Observational Study: An observational study entails the observation and description of individuals or patients based on their exposure to an intervention or risk factor. In contrast to a trial, investigators do not deliver an intervention or manipulate its use; ie, they do not assign patients to treatment and control groups. Specific guidelines vary according to study design and are listed below. Although no dedicated guidelines are available for reports from registries, AJKD also considers observational studies of this form.

o Cohort Study

The STROBE Checklist for Cohort Studies should be used.

o Case-Control Study

The STROBE Checklist for Case-Control Studies should be used.

o Cross-sectional Study

The STROBE Checklist for Cross-sectional Studies should be used.

o Gene-Disease Association Study

This subtype of observational study can use several different designs; published recommendations (Little J, Bradley L, Bray MS, et al. Reporting, appraising, and integrating data on genotype prevalence and gene-disease associations. Am J Epidemiol. 2006;156(4):300-310) should be followed.

iii. Case Series: A case series is a retrospective description of the clinical course of several individuals or patients. Unlike an observational study, a case series may or may not have a predictor.

iv. Systematic Review or Meta-analysis: A systematic review follows an explicit protocol to systematically identify, appraise, and synthesize the findings of studies that address a similar question; a meta-analysis, which contains a quantitative synthesis of the results of the systematic review, is preferred, whenever possible. The QUOROM Flow Diagram should be consulted for reporting study yield and selection. Specific guidelines vary according to the studies analyzed, as listed below.

o Meta-analysis of Randomized Controlled Trials

The QUOROM Meta-analysis of RCTs Checklist should be used.

o Meta-analysis of Observational Studies

The MOOSE Meta-analysis of Observational Studies Checklist should be used.

o Meta-analysis of Gene-Disease Association Studies

The HuGENet HuGE Review Handbook, version 1.0 (170 KB PDF available at www.genesens.net/_intranet/doc_nouvelles/HuGE%20Review%20Handbook%20v11.pdf) should be consulted.

v. Decision Analysis or Cost-Effectiveness Analysis: A decision analysis weighs choices in a clinical scenario by modeling the projected consequences of different strategies in order to identify the optimal choice or to inform clinical decision-making or public policy. The following published recommendations for format should be followed.

1. Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analyses. Panel on Cost-effectiveness in Health and Medicine. JAMA. 1996;276(16):1339-1341.

2. Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party. BMJ. 1996;313(7052):275-283.

vi. Quality Improvement Report: A quality improvement report describes an activity that was conducted as an initiative to improve quality of care and that does not follow the design of a prospective research study such as a clinical trial or an observational study. Published recommendations (Davidoff F, Batalden P. Toward stronger evidence on quality improvement. Draft publication guidelines: the beginning of a consensus project. Qual Saf Health Care. 2005;14(5): 319-325) for format should be followed; a summary of these is available as a checklist.

vii. Study of Diagnostic Accuracy: A study of diagnostic accuracy is a study comparing the performance of 2 or more diagnostic tests. The STARD Flowchart of Diagnostic Test Results should be followed for reporting participant flow through enrollment, testing, and results and the STARD Checklist should be consulted for format recommendations.

Case Reports should be succinct and original and should have a single, well-defined message. These articles are limited to 1,400 words and no more than 2 figures or tables; an abstract is required. Case Reports consist of an Introduction, Case Report, and Discussion. Criteria for review will include clinical plausibility and originality.

Narrative Reviews may cover any clinical, translational, or basic science topic of interest to practitioners. These articles are limited to 4,000 words and must include an abstract. Criteria for review will include originality, comprehensiveness, and balance of viewpoints.

Editorials provide focused commentary and analysis concerning a topic of interest to AJKD readers. These articles may be up to 1,400 words and may include 1 figure or table. Editorials are usually invited but may be submitted without invitation on articles published in AJKD or in other journals, or on a current issue in nephrology.

Letters to the Editor may be in response to an article in AJKD or may concern a topic of interest in current nephrology. For responses to AJKD articles, the letter must be received no more than 6 weeks after the article’s date of print publication. The body of the letter should be as concise as possible and in general should not exceed 250 words. A maximum of 3 authors may be listed on a letter, and up to 10 references and 1 figure or table may be included. There is no guarantee that letters will be published. Letters are subject to editing and abridgment without notice.

Special Articles encompass content that does not fit in the aforementioned categories and may cover any topic of interest to AJKD readers. These articles are limited to 4,000 words and must include an abstract.

AJKD also welcomes submissions for the following features:

Quiz Page: An image-based educational feature that recurs monthly; images from the page often appear on the cover of AJKD. The first section includes a concise clinical history (150 words or fewer), a maximum of 4 figures, and 1 to 4 brief questions pertaining to the case. An answer to each question, further information regarding the clinical entity, and a brief statement of the final diagnosis should be provided in a separate answer section, which may include an additional 2 to 4 figures and in most cases should be limited to 200 words. Quiz Pages from February 2007 onwards may be consulted as examples of the preferred organization; however, for initial submission, Quiz Pages should include a standard title page.

Kidney Biopsy Teaching Case: A case report to educate clinicians on pathologic correlates of clinical presentations, with key educational points well delineated in the discussion. These teaching cases are limited to 1,800 words and no more than 4 figures or tables, do not include abstracts, and are organized into the following sections: Introduction, Case Report (with the subsections Clinical History, Kidney Biopsy, Diagnosis, and Clinical Follow-up), and Discussion.

Acid-Base and Electrolyte Teaching Case: A case report to educate clinicians on acid-base and electrolyte pathophysiology and the interpretation of serum and urine chemistries in clinical practice. Key points should be clearly delineated in the discussion. These teaching cases are limited to 1,800 words and no more than 4 figures or tables, do not include abstracts, and are organized into the following sections: Introduction, Case Report (with the subsections Clinical History, Additional Investigations, Diagnosis, and Clinical Follow-up), and Discussion.

Imaging Teaching Case: A case report to educate clinicians on interpretation and applications of imaging in clinical nephrology. Key educational points should be clearly delineated in the discussion. These teaching cases are limited to 1,800 words and no more than 4 figures or tables, do not include abstracts, and are organized into the following sections: Introduction, Case Report (with the subsections Clinical History, Additional Investigations, Diagnosis, and Clinical Follow-up), and Discussion.

In Translation: An authoritative, cutting-edge analysis of developments in basic science with diagnostic or therapeutic implications in the clinical practice of nephrology. This feature includes a clinical vignette and describes the pathogenesis of a disease process or its complications as well as recent advances in the field, giving particular attention to cellular and molecular mechanisms of disease and their relation to diagnostic approaches or therapeutic applications. These articles may have up to 4,000 words and 6 figures or tables; an abstract is required. In Translation is organized into the following sections: Background (250 words), Case Vignette (300 words), Pathogenesis, Recent Advances, and Summary.

World Kidney Forum: A narrative review that explores the socioeconomic, geopolitical, ethical, and historical issues related to kidney disease and the wider world of nephrology. The Forum will recur quarterly; submissions should be 4,000 words or fewer, and an abstract is required.

Two editors will review all manuscripts submitted to AJKD, generally within 1 week. If the editors deem that the manuscript is unlikely to be published in AJKD, it may be rejected at this stage. With the exception of letters, Quiz Pages, and invited editorials, manuscripts will then undergo external review. Further details on the review process are available in the Editorial Policies section of the AJKD website.

INFORMED CONSENT, QUALITY IMPROVEMENT ACTIVITIES, AND PRIVACY

Regardless of country of origin, all studies in humans must include a description of appropriate safeguards (eg, local Institutional Review Board, Ministry of Health approval) in the Methods section.

When submitting a quality improvement report, authors should indicate whether the plan for the quality improvement activity has been approved by the clinical leadership of the organization whose experience is reported.

Whenever possible, any information identifying individual study participants should be avoided. If identifying information is necessary, the patient must be shown the manuscript and provide written informed consent before publication.

CONFLICT OF INTEREST POLICY

AJKD policies and procedures generally follow those of the International Committee of Medical Journal Editors, as published in the "Uniform Requirement for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication" (updated October 2007; www.icmje.org).

A conflict of interest exists when an author, reviewer, or editor has financial or personal relationships with other persons or organizations that may inappropriately influence or bias his or her actions. There is a potential for a conflict of interest whether or not an individual believes that a relationship affects his or her scientific judgment. Conflicts can occur as the result of employment, consultancies, stock ownership, honoraria, paid expert testimony or opinions, personal and family relationships, or academic competitive pressures. All participants in the peer review and publication process must disclose all relationships that could be viewed as a potential conflict of interest.

Potential Author Conflicts

Authors should disclose at the time of manuscript submission all financial and interpersonal 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 or alternatives to tests or treatments. Authors should disclose information even when there is a question as to whether a relationship constitutes a conflict. Potential conflicts should be listed for each author on the page following the title page; a summary of relevant information will be published with the manuscript.

Authorship of editorials and reviews requires interpretation of the literature and therefore is inherently subject to bias, thus AJKD requests that authors of such manuscripts not have a significant financial interest in the subject matter of the manuscript.

Potential Reviewer Conflicts

Individuals who have potential conflicts of interest should not serve as peer reviewers. This includes individuals who closely collaborate either in clinical care or research with authors as well as individuals who may have a financial interest in the subject matter of the manuscript being reviewed. Authors may provide editors with the names of persons they feel should not review their manuscript because of a potential conflict. However, when possible, authors should explain the reason(s) for their concerns. Editors will try to avoid selecting reviewers who have potential conflicts of interest. Individuals who have been invited to review a manuscript must disclose any conflicts that could bias their opinions, and they should disqualify themselves from reviewing when appropriate.

Potential Editor Conflicts

AJKD follows comprehensive policies dictating the treatment of submissions that are associated with the editors. Detailed information is available in the Editorial Policies section of the AJKD website.

MANUSCRIPT PREPARATION AND SUBMISSION

All manuscripts are submitted and processed electronically using Editorial Manager, which is available at www.editorialmanager.com/ajkd. Assistance with Editorial Manager is available from the editorial office at +1 617-636-0599 or AJKD@tuftsmedicalcenter.org.

Authors should follow the recommended formats for reporting original research and the style guidelines listed in this document, even if this makes the manuscript exceed the listed length limitations. If revision is requested, the editors will provide guidance on appropriate reductions or the use of supplementary online materials.

Manuscripts must be double-spaced using 12-point type (preferably Times New Roman) and unjustified margins. Pages must be numbered starting with the title page.

Title Page

The title page should include the following: (1) title (concise and descriptive); (2) authors’ first and last names and highest degree; (3) institution of each author; (4) corresponding author’s name, address, telephone and fax numbers, and e-mail address; (5) word counts for the abstract and the body of the manuscript; and (6) a short title (45 characters or fewer, including spaces) to be used as a running head.

Note: All authors must have a significant role in the manuscript. This includes (1) conceiving of the study design or interpreting study results; (2) writing and/or revising the manuscript; and (3) approving the final version of the manuscript. All individuals who contributed to the writing of the manuscript must be identified either as an author or in the acknowledgements section of the manuscript. The author who is named as the corresponding author on the manuscript’s title page must be the same individual to whom all Editorial Manager–related correspondence is directed.

Support and Financial Disclosure Declaration

The second page of each manuscript should acknowledge research support (from funding agencies or industry) and disclose any potential financial conflicts of interest (relevant consulting fees, stock options, employment, etc) for each author. If no financial conflict of interest is identified, ‘none’ should be written next to the author name.

Note: If the manuscript is accepted for publication, a summary of the relevant information will be transferred to the “Support” and “Financial Disclosure” sections of the Acknowledgements.

Abstract

Original Investigations must include a brief (300 words or fewer) structured abstract followed by a short list of index words. Formats for abstracts differ according to type of study and should follow the guidelines listed in the following table. Abstracts for Case Reports, Narrative Reviews, Special Articles, and features may be unstructured and are limited to 200 words.

Clinical Trial	Background	Study Design	Setting & Participants	Intervention	Outcomes	Measurements	Results	Limitations	Conclusions
Observational Study	Background	Study Design	Setting & Participants	Predictor or Factor	Outcomes	Measurements	Results	Limitations	Conclusions
Diagnostic Test Study	Background	Study Design	Setting & Participants	Index Test	Reference Test or Outcome	Other Measurements (if applicable)	Results	Limitations	Conclusions
Quality Improvement Report	Background	Study Design	Setting & Participants	Quality Improvement Plan	Outcomes	Measurements	Results	Limitations	Conclusions
Case Series	Background	Study Design	Setting & Participants	Predictor or Factor (if applicable)	Outcomes	Measurements	Results	Limitations	Conclusions
Systematic Review or Meta-Analysis	Background	Study Design	Setting & Population	Selection Criteria for Studies	Intervention, Predictor or Factor, or Index Tests (select 1)	Outcomes or Reference Tests (select 1)	Results	Limitations	Conclusions
Decision Analysis/Cost- Effectiveness Analysis	Background	Study Design	Setting & Population	Model, Perspective, & Timeframe	Intervention	Outcomes	Results	Limitations	Conclusions

Although the abstract headings listed above are not identical to CONSORT recommendations, authors interested in further guidance on abstract preparation are referred to the following article: Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008;5(1):e20.

Manuscript Body

Original Investigations should be structured into the following sections: Introduction, Methods, Results, and Discussion. The Introduction and Discussion sections should not include any subheadings. Each section must conform to the recommended formats for reporting as described in this document.

Information on the organization of other article types is available in the individual article descriptions in “Categories of Articles” section.

Acknowledgements

If authors wish to express thanks or acknowledge assistance, an acknowledgements section should be inserted after the manuscript text and before the reference list. Additionally, all individuals who contributed to the writing of the manuscript but who do not qualify as authors must be cited in this section. Authors are responsible for informing all named individuals/parties that they are being mentioned in their submitted manuscript and obtaining their approval prior to publication.

Note: Until a manuscript is accepted for publication, support and financial disclosure information should remain on the page following the title page.

References

References should be compiled at the end of the manuscript according to the order of citation in the text and should follow the style and format recommended by the American Medical Association. A summary of the most common reference types is provided below. Authors using reference handling software (eg, EndNote, Reference Manager) should use the American Medical Association output style (equivalent to the JAMA style). Further information may also be found in the AMA Manual of Style.

Examples

Journal article (6 or fewer authors):

MacKinnon M, Shurraw S, Akbari A, Knoll GA, Jaffey J, Clark HD. Combination therapy with an angiotensin receptor blocker and an ACE inhibitor in proteinuric renal disease: A systematic review of the efficacy and safety data. Am J Kidney Dis. 2006;48(1):8-20.

Journal article (more than 6 authors):

Ponticelli C, Passerini P, Salvadori M, et al. A randomized pilot trial comparing methylprednisolone plus a cytotoxic agent versus synthetic adrenocorticotropic hormone in idiopathic membranous nephropathy. Am J Kidney Dis. 2006;47(2):233-240.

Journal article which has been published online but is not yet available in print:

St. Peter WL, Liu J, Weinhandl E, Fan Q. A comparison of sevelamer and calcium-based phosphate binders on mortality, hospitalization, and morbidity in hemodialysis: A secondary analysis of the dialysis clinical outcomes revisited (DCOR) randomized trial using claims data. Am J Kidney Dis. 2008. doi:10.1053/j.ajkd.2007.12.002.

Supplement:

National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis. 2006;47(5)(suppl 3):S1-S145.

Item presented at a meeting but not yet published:

Richardson MM, Saris-Baglama, RN, Anatchkova MD, et al. Patient experience of chronic kidney disease (CKD): Results of a focus group study. Poster presented at: National Kidney Foundation 2007 Spring Clinical Meeting; April 10-14, 2007; Orlando, FL.

Published meeting abstract:

Pudur S, Savin VJ, McCarthy ET, Sharma M. Albumin permeability (Palb) in focal segmental glomerulosclerosis (FSGS) is associated with rapid progression to end-stage renal disease (ESRD) [NKF abstract 127]. Am J Kidney Dis. 2006;47(4):B50.

Website:

Chronic Kidney Disease (CKD). National Kidney Foundation. http://www.kidney.org/kidneyDisease/ckd/index.cfm. Accessed January 4, 2008.

Complete book:

Ahmad S. Manual of Clinical Dialysis. London, England: Science Press Ltd; 1999.

Book chapter:

Batlle D. Metabolic acidosis. In: Greenberg A, ed. Primer on Kidney Diseases. 2nd ed. San Diego, CA: Academic Press; 1998:71-79.

Government or agency bulletin:

US Renal Data System. USRDS 2007 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Bethesda, MA: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2007.

Tables and Figures

Tables and figures should be cited in numerical order in the text using Arabic numbering.

Each table should be on a separate page of the manuscript file, and should appear immediately after the references. The table number and title should be included above the table on the same page. Any additional information, including Système International (SI) conversion factors, should be included in notes below each table.

Figure legends (figure title and other explanatory text) should be grouped on a separate page at the end of the manuscript file (immediately following the references and tables, if present). Each figure should have a legend. Titles and legends should not appear in the figure files themselves.

Figures should not be embedded within the manuscript file; instead they should be uploaded in the Editorial Manager system as separate files. For the purposes of initial evaluation, figures must be of sufficient quality to be legible and interpretable. If revision is requested, production-quality figures will be required, for which advice will be given. In general, authors should minimize conversions between file types. Resolution should not be reduced except in cases where file size would otherwise be impractically large; in most cases, pixel-based images should have a resolution of at least 1,200 dpi for line art (eg, graphs, flow charts) or 500 dpi for photographs, micrographs, computed tomography scans, and related images. Color images should use CMYK color mode. In rare cases, the journal may request hard copies of figures; however, no materials, including photomicrographs, can be returned.

Authors are responsible for applying for permission from the relevant publisher(s) for both print and electronic rights to all borrowed material and are responsible for paying any fees related to applying for these permissions. In addition to providing proof of permission to the AJKD editorial office, authors should include appropriate wording in the figure legend or table note to indicate the source of the material. Photographs of identifiable persons must be accompanied by a signed release that indicates informed consent.

Supplementary Materials for Online Publication

In cases where essential information associated with an article is too extensive for print publication (eg, a lengthy study questionnaire), this content can be included as online-only information. Supplementary materials file(s) should be provided at the time of manuscript submission, and should be called out in the text: Table S2, Fig S1, Item S4, etc. Titles and/or legends for each supplementary figure or item should be included as the final page of the manuscript document. Unless otherwise requested, supplementary materials will generally be corrected for style, grammar, or format. Information on copyright assignment for supplementary materials can be found in the Editorial Policies section of the AJKD website.

Abbreviations
To improve readability, only standard abbreviations should be used and all abbreviations should be expanded at first mention. Abbreviations in titles, abstracts, and running heads should be avoided. Expansions of all abbreviations used in tables and figures should be provided.

Generic Names

Generic names for drugs should be used throughout; if necessary, a proprietary name and the name and location of the drug manufacturer may be included in parentheses at first mention.

Units of Measurement

Throughout the text, most units of measurement should be expressed in conventional units. At first mention, the conversion factor for the SI unit should be given in parentheses; thereafter, only conventional units should be used. In abstracts, only conventional units should be used; no conversion factors are required. In figures and tables, conventional units should be used, with conversion factors given in legends or table notes. Manuscripts containing only conventional or SI units will not be returned, but correction will be requested if a revision is invited. For a complete list of values requiring SI units, as well as the conversion factors, authors may consult the SI Converter available at the AJKD website.

Examples

In text:

Serum creatinine at 3 months was 9.62 mg/dL (serum creatinine in mg/dL may be converted to µmol/L by multiplying by 88.4).

In figure legends:

Urea nitrogen in mg/dL may be converted to mmol/L by multiplying by 0.357. Potassium levels in mEq/L and mmol/L are equivalent.

In tables:

Serum Component	Patient 1	Patient 2
Creatinine	0.6 mg/dL	1.2 mg/dL
Urea nitrogen	8 mg/dL	18 mg/dL

Note: Serum creatinine in mg/dL may be converted to μmol/L by multiplying by 88.4; urea nitrogen in mg/dL to mmol/L by multiplying by 0.357.

Reporting P Values

Numerical values should always be reported for P, even if they are nonsignificant. If the P value is greater than or equal to 0.9, it should be reported as 0.9, eg, 0.91 and 0.97 become 0.9. P values from 0.001 through 0.9 (inclusive) should be rounded to one nonzero digit, eg, 0.0105 rounds to 0.01 and 0.0452 rounds to 0.05. P values less than 0.001 should be reported as <0.001, eg, 0.0009 and 1.92 x 10^-6 become <0.001.

CONDITIONS OF SUBMISSION

Manuscripts are considered for publication if and only if the article and its key features (1) are not under consideration elsewhere, (2) have not been published, and (3) will not appear in print or online prior to appearing in AJKD. This restriction does not apply to abstracts or press reports published in connection with scientific meetings.

Submission of a manuscript is understood to indicate that the authors have complied with all policies as delineated in this document and the online Editorial Policies. Individuals who violate these policies are subject to editorial action including but not limited to (1) disclosure of violations to employers, funding agencies, or other journal offices and/or (2) publication of a retraction, correction, or editorial.

PUBLICATION ON AJKD ELECTRONIC PAGES

Because AJKD receives many more meritorious papers than can be published in the print edition, some Case Reports may be accepted for publication solely on the AJKD website. The initial decision letter sent to the authors will indicate if the manuscript is being considered as an online Case Report. Articles that are published exclusively online will be listed in the printed table of contents and indexed in MEDLINE. Online Case Reports will incur no page charges or charges for color figures, but will be subject to the same copyright laws as the printed edition.

AFTER ACCEPTANCE

The copyright will be assigned exclusively to the National Kidney Foundation, including the right to reproduce the article in all forms and media. Permission requests are handled by the publisher, Elsevier; information on how to request permission is available in the Contact Information section of the AJKD website. Elsevier will not refuse any reasonable request by the author for permission to reproduce any of his or her contributions following publication in AJKD. Further information on copyright policies can be found in the Editorial Policies section of the AJKD website.

Page Charges

AJKD holds all authors responsible for payment of excess page charges for published manuscripts. Authors may publish up to 4 printed pages without any page charges; for each page in excess of the 4 free pages, authors are responsible for paying $75.00 per page or partial page. One printed text page is approximately equivalent to 2.5 double-spaced manuscript pages, 35 references, or 2 tables/figures. The letter of acceptance e-mailed to the author will provide an estimate of the page charges. The actual invoice for page charges will be sent to the corresponding author after the manuscript is published. If no response to the invoice or subsequent reminders is received within 3 months, the editorial office will place a publication hold on all further papers from all listed co-authors until the outstanding invoice is paid in full. Page charges and color reproduction costs are billed separately.

Color Reproduction Charges

Authors must bear all costs connected with printed color illustrations, with the exception of those appearing in Quiz Pages. The first color figure will cost $650 and each additional figure will cost $100; multipart figures generally will be considered as 1 figure. After a manuscript with color illustrations is accepted, the issue manager at Elsevier will contact the corresponding author, provide a cost estimate, and give a choice of publication in color or black and white. In some cases, authors may be able to have their color figure(s) produced in black and white for the print version of AJKD, but the figure(s) will appear in color for the online version. The issue manager will contact the author if there is a problem reproducing a figure. If the author chooses color reproduction, Elsevier (not the editorial office) will send the bill to the author. Color reproduction costs and page charges are billed separately.

Proofreading
Corresponding authors are provided with proofs via e-mail and are asked to proofread them for typesetting and/or copyediting errors. Important changes in data are allowed, but authors will be charged for excessive alterations to proofs. Corrections must be returned to Elsevier within 48 hours.

Reprints
Reprints of articles can be ordered before or after publication. Individuals wishing to obtain reprints of an article that appears in AJKD may do so by contacting the author at the address given in the article.

EDITORIAL OFFICE

Andrew S. Levey, MD, Editor-in-Chief

Daniel E. Weiner, MD, MS, Deputy Editor

Nijsje Dorman, PhD, Managing Editor

Elizabeth Frank, Associate Managing Editor

David Boffa, Editorial Assistant

US Postal Mail Address

AJKD Editorial Office

Division of Nephrology

Tufts Medical Center, Box 391

750 Washington St

Boston, MA 02111, USA

Express Mail Address

AJKD Editorial Office

Tufts Medical Center

35 Kneeland St, 1^st Floor

Boston, MA 02111, USA

Phone: +1 617-636-0599

Fax: +1 617-636-0598

E-mail: AJKD@tuftsmedicalcenter.org

Recommended Format for Reporting of Randomized Controlled Trials With Parallel Group Design According to the CONSORT Group O

Reference: Moher D, et al, for the CONSORT Group: The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials. Ann Intern Med 134: 657-662, 2001 (freely available at www.annals.org/cgi/reprint/134/8/657.pdf)

Paper Section and Topic	Item #	Descriptor
Title & Abstract	1	How participants were allocated to interventions (eg, random allocation, randomized, or randomly assigned).
Introduction
Background	2	Scientific background and explanation of rationale.
Methods
Participants	3	Eligibility criteria for participants and the settings and location where the data were collected.
Interventions	4	Precise details of the intervention intended for each group and how and when they were actually administered.
Objectives	5	Specific objectives and hypotheses.
Outcomes	6	Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (eg, multiple observations, training of assessors).
Sample size	7	How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.
Randomization
Sequence generation	8	Method used to generate the random allocation sequence, including details of any restriction (eg, blocking, stratification).
Allocation concealment	9	Method used to implement the random allocation sequence (eg, numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.
Implementation	10	Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.
Blinding (masking)	11	Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated.
Statistical methods	12	Statistical methods used to compare groups for primary outcome(s); methods for additional analyses, such as subgroup analyses and adjusted analyses.
Results
Participant flow	13	Flow of participants through each stage (include flowchart). Specifically, for each group report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from study as planned, together with reasons.
Recruitment	14	Dates defining the periods of recruitment and follow-up.
Baseline data	15	Baseline demographic and clinical characteristics of each group.
Numbers analyzed	16	Number of participants (denominator) in each group included in each analysis and whether the analysis was by intention-to-treat. State the results in absolute numbers when feasible (eg, 10 of 20, not 50%).
Outcomes and estimation	17	For each primary and secondary outcome, a summary of results for each group and the estimated effect size and its precision (eg, 95% confidence interval).
Ancillary analyses	18	Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those prespecified and those exploratory.
Adverse events	19	All important adverse events or side effects in each intervention group.
Discussion
Interpretation	20	Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes.
Generalizability	21	Generalizability (external validity) of the trial findings.
Overall evidence	22	General interpretation of the results in the context of current evidence.

Recommended Format for Reporting of Cluster-Randomized Trials According to the CONSORT Group O

Reference: Campbell M, et al, for the CONSORT Group: CONSORT Statement: Extension to cluster randomized trials. BMJ 328: 702-708, 2004 (freely available at bmj.bmjjournals.com/cgi/reprint/328/7441/702)

Paper Section and Topic	Item #		Descriptor (additions or modifications to CONSORT checklist for RCTs of parallel group design are in italics)
Title & Abstract
Design	1		How participants were allocated to interventions (eg, random allocation, randomized, or randomly assigned), specifying that allocation was based on clusters.
Introduction
Background	2	Scientific background and explanation of rationale, including the rationale for using a cluster design.
Methods
Participants	3		Eligibility criteria for participants and clusters and the settings and locations where the data were collected.
Interventions	4		Precise details of the interventions intended for each group, whether they pertain to the individual level, the cluster level, or both, and how and when they were actually administered.
Objectives	5		Specific objectives and hypotheses and whether they pertain to the individual level, the cluster level, or both.
Outcomes	6		Report clearly defined primary and secondary outcome measures, whether they pertain to the individual level, the cluster level, or both, and, when applicable, any methods used to enhance the quality of measurements (eg, multiple observations, training of assessors).
Sample size	7		How total sample size was determined (including methods of calculation, number of clusters, cluster size, a coefficient of intracluster correlation (ICC or k), and an indication of its uncertainty) and, when applicable, explanation of any interim analyses and stopping rules.
Randomization
Sequence generation	8	Method used to generate the random allocation sequence, including details of any restriction (eg, blocking, stratification, matching).
Allocation concealment	9	Method used to implement the random allocation sequence, specifying that allocation was based on clusters rather then individuals and clarifying whether the sequence was concealed until interventions were assigned.
Implementation	10	Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.
Blinding (masking)	11	Whether participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated.
Statistical methods	12	Statistical methods used to compare groups for primary outcome(s) indicating how clustering was taken into account; methods for additional analyses, such as subgroup analyses and adjusted analyses.
Results
Participant flow	13	Flow of clusters and individual participants through each stage (a diagram is strongly recommended). Specifically, for each group report the numbers of clusters and participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from study as planned, together with reasons.
Recruitment	14	Dates defining the periods of recruitment and follow-up.
Baseline data	15	Baseline information for each group for the individual and cluster levels as applicable.
Numbers analyzed	16	Number of clusters and participants (denominator) in each group included in each analysis and whether the analysis was by intention-to-treat. State the results in absolute numbers when feasible (eg, 10 of 20, not 50%).
Outcomes and estimation	17	For each primary and secondary outcome, a summary of results for each group for the individual or cluster level, as applicable, and the estimated effect size and its precision (eg, 95% confidence interval) and a coefficient of intracluster correlation (ICC or k) for each primary outcome.
Ancillary analyses	18	Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those prespecified and those exploratory.
Adverse events	19	All important adverse events or side effects in each intervention group.
Discussion
Interpretation	20	Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.
Generalizability	21	Generalizability (external validity) to individuals and/or clusters (as relevant) of the trial findings.
Overall evidence	22	General interpretation of the results in the context of current evidence.

Recommended Format for Reporting of Noninferiority and Equivalence Trials According to the CONSORT Group O

Reference: Piaggio G, et al, for the CONSORT Group: Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT Statement. JAMA 295:1152-1160, 2006 (freely available at jama.ama-assn.org/cgi/reprint/295/10/1152)

Paper Section and Topic	Item #	Descriptor (additions or modifications to CONSORT checklist for RCTs of parallel group design are in italics)
Title & Abstract	1	How participants were allocated to interventions (eg, random allocation, randomized, or randomly assigned), specifying that the trial is a noninferiority or equivalence trial.
Introduction
Background	2	Scientific background and explanation of rationale, including the rationale for using a noninferiority or equivalence design.
Methods
Participants	3	Eligibility criteria for participants (detailing whether participants in the noninferiority or equivalence trial are similar to those in any trial(s) that established efficacy of the reference treatment) and the settings and locations where the data were collected.
Interventions	4	Precise details of the interventions intended for each group, detailing whether the reference treatment in the noninferiority or equivalence trial is identical (or very similar) to that in any trial(s) that established efficacy, and how and when they were actually administered.
Objectives	5	Specific objectives and hypotheses, including the hypothesis concerning noninferiority or equivalence.
Outcomes	6	Clearly defined primary and secondary outcome measures, detailing whether the outcomes in the noninferiority or equivalence trial are identical (or very similar) to those in any trial(s) that established efficacy of the reference treatment and, when applicable, any methods used to enhance the quality of measurements (eg, multiple observations, training of assessors).
Sample size	7	How sample size was determined, detailing whether it was calculated using a noninferiority or equivalence criterion and specifying the margin of equivalence with the rationale for its choice. When applicable, explanation of any interim analyses and stopping rules (and whether related to a noninferiority or equivalence hypothesis).
Randomization
Sequence generation	8	Method used to generate the random allocation sequence, including details of any restriction (eg, blocking, stratification).
Allocation concealment	9	Method used to implement the random allocation sequence (eg, numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.
Implementation	10	Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.
Blinding (masking)	11	Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. When relevant, how the success of blinding was evaluated.
Statistical Methods	12	Statistical methods used to compare groups for primary outcome(s), specifying whether a 1- or 2-sided confidence interval approach was used. Methods for additional analyses, such as subgroup analyses and adjusted analyses.
Results
Participant flow	13	Flow of participants through each stage (include flowchart). Specifically, for each group report the numbers of participants randomly assigned, receiving intended treatment, completing the trial protocol, and analyzed for the primary outcome. Describe protocol deviations from trial as planned, together with reasons.
Recruitment	14	Dates defining the periods of recruitment and follow-up.
Baseline data	15	Baseline demographic and clinical characteristics of each group.
Numbers analyzed	16	Number of participants (denominator) in each group included in each analysis and whether intention-to-treat and/or alternative analyses were conducted. State the results in absolute numbers when feasible (eg, 10 of 20, not 50%).
Outcomes and estimation	17	For each primary and secondary outcome, a summary of results for each group and the estimated effect size and its precision (eg, 95% confidence interval). For the outcome(s) for which noninferiority or equivalence if hypothesized, a figure showing confidence intervals and margins of equivalence may be useful.
Ancillary analyses	18	Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those prespecified and those exploratory.
Adverse events	19	All important adverse events or side effects in each intervention group.
Discussion
Interpretation	20	Interpretation of the results, taking into account the noninferiority or equivalence hypothesis and any other trial hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.
Generalizability	21	Generalizability (external validity) of the trial findings.
Overall evidence	22	General interpretation of the results in the context of current evidence.

Recommended Format for Reporting of Randomized Controlled Trials of Herbal Medicine Interventions According to the CONSORT Group O

Reference: Gagnier J, et al, for the CONSORT Group: Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT Statement. Ann Intern Med 144.5: 364-367, 2006 (freely available at www.annals.org/cgi/reprint/144/5/364.pdf)

Paper Section and Topic	Item #	Descriptor (additional requirements for item 4 of the CONSORT checklist for RCTs of parallel group design)
Methods
Interventions	4	Where applicable, the description of an herbal intervention should include:
	4A: Herbal medicinal product name	1. The Latin binomial name together with botanical authority and family name for each herbal ingredient; common name(s) should also be included. 2. The proprietary product name (ie, brand name) or the extract name (eg, EGb-761) and the name of the manufacturer of the product. 3. Whether the product used is authorized (licensed, registered) in the country in which the study was conducted.
	4B: Characteristics of the herbal product	1. The part(s) of the plant used to produce the product or extract. 2. The type of product used (eg, raw [fresh or dry], extract). 3. The type and concentration of extraction solvent used (eg, 80% ethanol, 100% H₂O, 90% glycerine, etc) and the ratio of herbal drug to extract (eg, 2 to 1). 4. The method of authentication of raw material (ie, how done and by whom) and the lot number of the raw material. State if a voucher specimen (ie, retention sample) was retained and, if so, where it is kept or deposited, and the reference number.
	4C: Dosage regimen and quantitative description	1. The dosage of the product, the duration of administration, and how these were determined. 2. The content (eg, as weight, concentration; may be given as range where appropriate) of all quantified herbal product constituents, both native and added, per dosage unit form. Added materials, such as binders, fillers, and other excipients (eg, 17% maltodextrin, 3% silicon dioxide per capsule), should also be listed. 3. For standardized products, the quantity of active/marker constituents per dosage unit form.
	4D: Qualitative testing	1. Product’s chemical fingerprint and methods used (equipment and chemical reference standards) and who performed the chemical analysis (eg, the name of the laboratory used); whether a sample of the product (ie, retention sample) was retained and if so, where it is kept or deposited. 2. Description of any special testing/purity testing (eg, heavy metal or other contaminant testing) undertaken, which unwanted components were removed and how (ie, methods). 3. Standardization: what to standardize (eg, which chemical components of the product) and how (eg, chemical processes or biological/functional measures of activity).
	4E: Placebo/control group	The rationale for the type of control/placebo used.
	4F: Practitioner	A description of the practitioners (eg, training and practice experience) who are a part of the intervention.

Recommended Format for the Reporting of Harms in Randomized Controlled Trials According to the CONSORT Group O

Reference: Ioannidis J, et al, for the CONSORT Group: Better reporting of harms in randomized trials: an extension of the CONSORT Statement. Ann Intern Med 141:781-788, 2004 (freely available at www.annals.org/cgi/reprint/141/10/781.pdf)

Paper Section and Topic	Item #	Descriptor (additional requirements for reporting harms in an RCT are outlined below; for all other items see CONSORT checklist for RCTs of parallel group design)
Title & Abstract	1	If the study collected data on harms and benefits, the title or abstract should so state.
Introduction
Background	2	If the trial addresses both harms and benefits, the introduction should so state.
Methods
Participants	3
Interventions	4
Objectives	5
Outcomes	6	List addressed adverse events with definitions for each (with attention, when relevant, to grading, expected vs unexpected events, reference to standardized and validated definitions, and description of new definitions). Clarify how harms-related information was collected (mode of data collection, timing, attribution methods, intensity of ascertainment, and harms-related monitoring and stopping rules, if pertinent).
Sample size	7
Randomization
Sequence generation	8
Allocation concealment	9
Implementation	10
Blinding (masking)	11
Statistical methods	12	Describe plans for presenting and analyzing information on harms (including coding, handling of recurrent events, specification of timing issues, handling of continuous measures, and any statistical analyses).
Results
Participant flow	13	Describe for each arm the participant withdrawals that are due to harms and their experiences with the allocated treatment.
Recruitment	14
Baseline data	15
Numbers analyzed	16	Provide the denominators for analyses of harms.
Outcomes and estimation	17	Present the absolute risk per arm and per adverse event by type, grade, and seriousness, and present appropriate metrics for recurrent events, continuous variables, and scale variables, whenever pertinent. Describe any subgroup analyses and exploratory analyses for harms.
Ancillary analyses	18
Adverse events	19
Discussion
Interpretation	20	Provide a balanced discussion of benefits and harms with emphasis on study limitations, generalizability, and other sources of information on harms.
Generalizability	21
Overall evidence	22

Recommended Format for Reporting of Nonrandomized Evaluations of Behavioral and Public Health Interventions According to the TREND Group O

Reference: Des Jarlais D, et al, and the TREND Group: Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND Statement.

Am J Public Health 94:361-366, 2004 (freely available at www.ajph.org/cgi/reprint/94/3/361)

Paper Section and Topic	Item #	Descriptor (items in italics are specifically added, modified, or further emphasized from CONSORT checklist for RCTs of parallel group design, since they are relevant for reporting behavioral interventions using nonrandomized experimental designs)
Title & Abstract	1	Information on how units were allocated to interventions. Information on target population or study sample.
Introduction
Background	2	Scientific background and explanation of rationale. Theories used in designing behavioral interventions.
Methods
Participants	3	Eligibility criteria for participants, including criteria at different levels in recruitment/sampling plan (eg, cities, clinics, subjects). Method of recruitment (eg, referral, self-selection), including the sampling method if a systematic sampling plan was implemented. Recruitment setting. Settings and locations where the data were collected.
Interventions	4	Details of the interventions intended for each study condition and how and when they were actually administered, specifically including: Content: what was given? Delivery method: how was content given? Unit of delivery: how were subjects grouped during delivery? Deliverer: who delivered intervention? Setting: where was the intervention delivered? Exposure quantity and duration: how many sessions or episodes or events were intended to be delivered? How long were they intended to last? Time span: how long was it intended to take to deliver the intervention to each unit? Activities to increase compliance or adherence (eg, incentives).
Objectives	5	Specific objectives and hypotheses.
Outcomes	6	Clearly defined primary and secondary outcome measures. Methods used to collect data and any methods used to enhance the quality of measurements. Information on validated instruments such as psychometric and biometric properties.
Sample size	7	How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.
Assignment method	8	Unit of assignment (the unit being assigned to study condition, eg, individual, group, community). Method used to assign units to study conditions, including details of any restriction (eg, blocking, stratification, minimization). Inclusion of aspects employed to help minimize potential bias induced due to nonrandomization (eg, matching).
Blinding (masking)	9	Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to study condition assignment; if so, statement regarding how the blinding was accomplished and how it was assessed.
Unit of analysis	10	Description of the smallest unit that is being analyzed to assess intervention effects (eg, individual, group, or community). If the unit of analysis differs from the unit of assignment, the analytical method used to account for this (eg, adjusting the standard error estimates by the design effect or using multilevel analysis).
Statistical methods	11	Statistical methods used to compare study groups for primary outcome(s), including complex methods for correlated data. Statistical methods used for additional analyses, such as subgroup analyses and adjusted analysis. Methods for imputing missing data, if used. Statistical software or programs used.
Results
Participant flow	12	Flow of participants through each stage of the study, specifically: Enrollment: the numbers of participants screened for eligibility, found to be eligible or not eligible, declined to be enrolled, and enrolled in the study. Assignment: the numbers of participants assigned to a study condition. Allocation and intervention exposure: the number of participants assigned to each study condition and the number of participants who received each intervention. Follow-up: the number of participants who completed the follow-up or did not complete the follow-up (ie, lost to follow-up), by study condition. Analysis: the number of participants included in or excluded from the main analysis, by study condition. Description of protocol deviations from study as planned, along with reasons.
Recruitment	13	Dates defining the periods of recruitment and follow-up.
Baseline data	14	Baseline demographic and clinical characteristics of participants in each study condition. Baseline characteristics for each study condition relevant to specific disease prevention research. Baseline comparisons of those lost to follow-up and those retained, overall and by study condition. Comparison between study population at baseline and target population of interest.
Baseline equivalence	15	Data on study group equivalence at baseline and statistical methods used to control for baseline differences.
Numbers analyzed	16	Number of participants (denominator) included in each analysis for each study condition, particularly when the denominators change for different outcomes; statement of the results in absolute numbers when feasible. Indication of whether the analysis strategy was intention-to-treat or, if not, description of how noncompliers were treated in the analyses.
Outcomes and estimation	17	For each primary and secondary outcome, a summary of results for each study condition, and the estimated effect size and a confidence interval to indicate the precision. Inclusion of null and negative findings. Inclusion of results from testing prespecified causal pathways through which the intervention was intended to operate, if any.
Ancillary analyses	18	Summary of other analyses performed, including subgroup or restricted analyses, indicating which are prespecified or exploratory.
Adverse events	19	Summary of all important adverse events or unintended effects in each study condition (including summary measures, effect size estimates, and confidence intervals).
Discussion
Interpretation	20	Interpretation of the results, taking into account study hypotheses, sources of potential bias, imprecision of measures, multiplicative analyses, and other limitations or weaknesses of the study. Discussion of results taking into account the mechanism by which the intervention was intended to work (causal pathways) or alternative mechanisms or explanations. Discussion of the success of and barriers to implementing the intervention, fidelity of implementation. Discussion of research, programmatic, or policy implications.
Generalizability	21	Generalizability (external validity) of the trial findings, taking into account the study population, the characteristics of the intervention, length of follow-up, incentives, compliance rates, specific sites/settings involved in the study, and other contextual issues.
Overall evidence	22	General interpretation of the results in the context of current evidence and current theory.

Note: Masking (blinding) of participants or those administering the intervention may not be relevant or possible for many behavioral interventions. Theories used to design the interventions (see item 2) could also be reported as part of item 4. The comparison between study population at baseline and target population of interest (see item 14) could also be reported as part of item 21.

Recommended Format for the Reporting of Observational Cohort Studies According to the STROBE Group O

Reference: von Elm E, et al, for the STROBE Initiative: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies. PLoS Med 4:e296, 2007 (freely available at medicine.plosjournals.org/perlserv/?request=get-pdf&file=10.1371_journal.pmed.0040296-L.pdf)

Paper Section and Topic	Item #	Recommendation
Title & Abstract	1	Indicate the study’s design with a commonly used term in the title or the abstract. Provide in the abstract an informative and balanced summary of what was done and what was found.
Introduction
Background/Rationale	2	Explain the scientific background and rationale for the investigation being reported.
Objectives	3	State specific objectives, including any prespecified hypotheses.
Methods
Study design	4	Present key elements of study design early in the paper.
Setting	5	Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection.
Participants	6	Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up. For matched studies, give matching criteria and number of exposed and unexposed.
Variables	7	Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable.
Data sources/ measurement	8*	For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than 1 group.
Bias	9	Describe any efforts to address potential sources of bias.
Study size	10	Explain how the study size was arrived at.
Quantitative variables	11	Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why.
Statistical methods	12	Describe all statistical methods, including those used to control for confounding. Describe any methods used to examine subgroups and interactions. Explain how missing data were addressed. If applicable, explain how loss to follow-up was addressed. Describe any sensitivity analyses.
Results
Participants	13*	Report numbers of individuals at each stage of study—eg, numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analyzed. Give reasons for nonparticipation at each stage. Consider use of a flow diagram.
Descriptive data	14*	Give characteristics of study participants (eg, demographic, clinical, social) and information on exposures and potential confounders. Indicate number of participants with missing data for each variable of interest. Summarize follow-up time (eg, average and total amount).
Outcome data	15*	Report numbers of outcome events or summary measures over time.
Main results	16	Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and why they were included. Report category boundaries when continuous variables were categorized. If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period.
Other analyses	17	Report other analyses done—eg, analyses of subgroups and interactions, and sensitivity analyses.
Discussion
Key results	18	Summarize key results with reference to study objectives.
Limitations	19	Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias.
Interpretation	20	Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence.
Generalizability	21	Discuss the generalizability (external validity) of the study results.
Funding	22	Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based.

* Give such information separately for cases and controls in case-control studies, and if applicable for exposed and unexposed groups in cohort and cross-sectional studies.

Adapted with permission from the STROBE group: www.strobe-statement.org.

Further information freely available at: medicine.plosjournals.org/perlserv/?request=get-pdf&file=10.1371_journal.pmed.0040297-L.pdf

Recommended Format for the Reporting of Observational Case-Control Studies According to the STROBE Group O

Reference: von Elm E, et al, for the STROBE Initiative: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies. PLoS Med 4:e296, 2007 (freely available at medicine.plosjournals.org/perlserv/?request=get-pdf&file=10.1371_journal.pmed.0040296-L.pdf)

Paper Section and Topic	Item #	Recommendation
Title & Abstract	1	Indicate the study’s design with a commonly used term in the title or the abstract. Provide in the abstract an informative and balanced summary of what was done and what was found.
Introduction
Background/Rationale	2	Explain the scientific background and rationale for the investigation being reported.
Objectives	3	State specific objectives, including any prespecified hypotheses.
Methods
Study design	4	Present key elements of study design early in the paper.
Setting	5	Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection.
Participants	6	Give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls. For matched studies, give matching criteria and the number of controls per case.
Variables	7	Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable.
Data sources/ measurement	8*	For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than 1 group.
Bias	9	Describe any efforts to address potential sources of bias.
Study size	10	Explain how the study size was arrived at.
Quantitative variables	11	Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why.
Statistical methods	12	Describe all statistical methods, including those used to control for confounding. Describe any methods used to examine subgroups and interactions. Explain how missing data were addressed. If applicable, explain how matching of cases and controls was addressed. Describe any sensitivity analyses.
Results
Participants	13*	Report numbers of individuals at each stage of study—eg, numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analyzed. Give reasons for nonparticipation at each stage. Consider use of a flow diagram.
Descriptive data	14*	Give characteristics of study participants (eg, demographic, clinical, social) and information on exposures and potential confounders. Indicate number of participants with missing data for each variable of interest.
Outcome data	15*	Report numbers in each exposure category, or summary measures of exposure.
Main results	16	Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and why they were included. Report category boundaries when continuous variables were categorized. If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period.
Other analyses	17	Report other analyses done—eg, analyses of subgroups and interactions, and sensitivity analyses.
Discussion
Key results	18	Summarize key results with reference to study objectives.
Limitations	19	Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias.
Interpretation	20	Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence.
Generalizability	21	Discuss the generalizability (external validity) of the study results.
Funding	22	Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based.

* Give such information separately for cases and controls in case-control studies, and if applicable for exposed and unexposed groups in cohort and cross-sectional studies.

Adapted with permission from the STROBE group: www.strobe-statement.org.

Further information freely available at: medicine.plosjournals.org/perlserv/?request=get-pdf&file=10.1371_journal.pmed.0040297-L.pdf

Recommended Format for the Reporting of Observational Cross-sectional Studies According to the STROBE Group O

Reference: von Elm, et al, for the STROBE Initiative: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies. PLoS Med 4:e296, 2007 (freely available at medicine.plosjournals.org/perlserv/?request=get-pdf&file=10.1371_journal.pmed.0040296-L.pdf)

Paper Section and Topic	Item #	Recommendation
Title & Abstract	1	Indicate the study’s design with a commonly used term in the title or the abstract. Provide in the abstract an informative and balanced summary of what was done and what was found.
Introduction
Background/Rationale	2	Explain scientific background and rationale for the investigation being reported.
Objectives	3	State specific objectives including any prespecified hypotheses.
Methods
Study design	4	Present key elements of study design early in the paper.
Setting	5	Describe setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection.
Participants	6	Give the eligibility criteria, and the sources and methods of selection of participants.
Variables	7	Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable.
Data sources/ measurement	8*	For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than 1 group.
Bias	9	Describe any efforts to address potential sources of bias.
Study size	10	Explain how the study size was arrived at.
Quantitative variables	11	Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why.
Statistical methods	12	Describe all statistical methods including those to control for confounding. Describe any methods used to examine subgroups and interactions. Explain how missing data were addressed. If applicable, describe analytical methods taking account of sampling strategy. Describe any sensitivity analysis.
Results
Participants	13*	Report the numbers of individuals at each stage of the study—numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow up, and analyzed. Give reasons for nonparticipation at each stage. Consider use of flow diagram.
Descriptive data	14*	Give characteristics of study participants (eg, demographic, clinical, social) and information on exposures and potential confounders. Indicate number of participants with missing data for each variable of interest.
Outcome data	15*	Report numbers of outcome events or summary measures.
Main results	16	Give unadjusted estimates and, if applicable, confounder adjusted estimates and their precision (eg, 95% confidence intervals). Make clear which confounders were adjusted for and why they were included. Report category boundaries when continuous variables were categorized. If relevant, consider translating estimates of relative risk into absolute risk for meaningful time period.
Other analyses	17	Report other analyses done—eg, analyses of subgroups and interactions, and sensitivity analyses.
Discussion
Key results	18	Summarize key results with reference to study objectives.
Limitations	19	Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias.
Interpretation	20	Give a cautious overall interpretation of the results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence.
Generalizability	21	Discuss the generalizability (external validity) of the study results.
Funding	22	Give source of funding and role of funder(s) for the present study and, if applicable, the original study on which the present article is based.

* Give such information separately for cases and controls in case-control studies, and if applicable for exposed and unexposed groups in cohort and cross-sectional studies.

Adapted with permission from the STROBE group: www.strobe-statement.org.

Further information freely available at: medicine.plosjournals.org/perlserv/?request=get-pdf&file=10.1371_journal.pmed.0040297-L.pdf

Recommended Format for Meta-analyses of Randomized Controlled Trials According to the QUOROM Group O

Reference: Moher D, et al, for the QUOROM Group: Improving the quality of reports of meta-analyses of randomized controlled trials: the QUOROM Statement. Quality Reporting of Meta-analyses. Lancet 354:1896-1900, 1999 (freely available at www.consort-statement.org/mod_product/uploads/QUOROM%20Statement%201999.pdf)

Heading	Subheading	Descriptor
Title		Identify the report as a meta-analysis (or systematic review) of RCTs.
Abstract	Objectives	Describe the clinical question explicitly.
	Data sources	Describe the databases (ie, list) and other information sources.
	Review methods	Describe the selection criteria (ie, population, intervention, outcome, and study design): methods for validity assessment, data abstraction, and study characteristics, and quantitative data synthesis in sufficient detail to permit replication.
	Results	Describe characteristics of the RCTs included and excluded; qualitative and quantitative findings (ie, point estimates and confidence intervals); and subgroup analyses.
	Conclusion	Describe the main results.
Introduction		Describe the explicit clinical problem, biological rationale for the intervention, and rationale for review.
Methods	Searching	Describe the information sources, in detail (eg, databases, registers, personal files, expert informants, agencies, hand-searching), and any restrictions (years considered, publication status, language of publication).
	Selection	Describe the inclusion and exclusion criteria (defining population, intervention, principal outcomes, and study design).
	Validity assessment	Describe the criteria and process used (eg, masked conditions, quality assessment, and their findings).
	Data abstraction	Describe the process or processes used (eg, completed independently, in duplicate).
	Study characteristics	Describe the type of study design, participants’ characteristics, details of intervention, outcome definitions, etc, and how clinical heterogeneity was assessed.
	Quantitative data synthesis	Describe the principal measures of effect (eg, relative risk), method of combining results (statistical testing and confidence intervals), handling of missing data; how statistical heterogeneity was assessed; a rationale for any a priori sensitivity and subgroup analyses; and any assessment of publication bias.
Results	Trial flow	Provide a meta-analysis profile summarizing trial flow.
	Study characteristics	Present descriptive data for each trial (eg, age, sample size, intervention, dose, duration, follow-up period).
	Quantitative data synthesis	Report agreement on the selection and validity assessment; present simple summary results (for each treatment group in each trial, for each primary outcome); present data needed to calculate effect sizes and confidence intervals in intention-to-treat analyses (eg, 2X2 tables of counts, means and SDs, proportions).
Discussion		Summarize key findings; discuss clinical inferences based on internal and external validity; interpret the results in light of the totality of available evidence; describe potential biases in the review process (eg, publication bias); and suggest a future research agenda.

Recommended Format for Meta-analyses of Observational Studies According to the MOOSE Group O

Reference: Stroup D, et al, for the MOOSE Group: Meta-analysis of observational studies in epidemiology: A proposal for reporting. JAMA 283: 2008-2012, 2000 (freely available at jama.ama-assn.org/cgi/reprint/283/15/2008)

Reporting of background should include:	Problem definition.
	Hypothesis statement.
	Description of study outcome(s).
	Type of exposure or intervention used.
	Type of study designs used.
	Study population.
Reporting of search strategy should include:	Qualifications of searchers (eg, librarians and investigators).
	Search strategy, including time period included in the synthesis and keywords.
	Effort to include all available studies, including contact with authors.
	Databases and registries searched.
	Search software used, name and version, including special features used (eg, explosion).
	Use of hand searching (eg, reference lists of obtained articles).
	List of citations located and those excluded, including justification.
	Method of addressing articles published in languages other than English.
	Methods of handling abstracts and unpublished studies.
	Description of any contact with authors.
Reporting of methods should include:	Description of relevance or appropriateness of studies assembled for assessing the hypothesis to be tested.
	Rationale for the selection and coding of data (eg, sound clinical principles or convenience).
	Documentation of how data were classified and coded (eg, multiple raters, blinding, and interrater reliability).
	Assessment of confounding (eg, comparability of cases and controls in studies where appropriate).
	Assessment of study quality, including blinding of quality assessors; stratification or regression on possible predictors on study results.
	Assessment of heterogeneity.
	Description of statistical methods (eg, complete description of fixed or random effects models, justification of whether the chosen models account for predictors of study results, dose-response models, or cumulative meta-analysis) in sufficient detail to be replicated.
	Provision of appropriate tables and graphics.
Reporting of results should include:	Graphic summarizing individual study estimates and overall estimate.
	Table giving descriptive information for each study included.
	Results of sensitivity testing (eg, subgroup analysis).
	Indication of statistical uncertainty of findings.
Reporting of discussion should include:	Quantitative assessment of bias (eg, publication bias). Justification for exclusion (eg, exclusion of non-English-language citations). Assessment of quality of included studies.
Reporting of conclusions should include:	Consideration of alternative explanations for observed results.
	Generalization of the conclusions (ie, appropriate for the data presented and within the domain of the literature review).
	Guidelines for future research.
	Disclosure of funding source.

Recommended Format for Reporting Quality Improvement Evidence* O

Reference: Davidoff F, Batalden P: Toward stronger evidence on quality improvement. Draft publication guidelines: the beginning of a consensus project. Qual Saf Health Care 2005;14:319-325 (freely available at qshc.bmj.com/cgi/reprint/14/5/319)

Paper section	Item #	Descriptor and topic
Title & Abstract	1	Indication that this is a quality improvement article.
Introduction
Background	2	Current organizational and clinical knowledge about the problem area.
Problem	3	Nature and severity of specific local dysfunction or failure.
Purpose of change(s)	4	Specific aim(s) of proposed changes, ie, questions to be answered.
Methods
Setting	5	Relevant details of geographic location, local organization, staffing.
Function	6	Purpose, processes, and activities of department, team, unit, program.
Intervention(s)	7	Precise details of initial strategy for intended changes/improvements.
Measures	8	Balance of methods used to assess dysfunction/failure and outcomes of changes, including measurement perspective (eg, patients, staff, administration, cost, etc); methods used to validate measures.
Analytical methods	9	Statistical and time series techniques used; specific software (if any).
Results
Situation analysis	10	Initial assessment of local context of the care system (eg, specifics of the patient population, local experience with change, etc) and how that assessment helped understand the problem.
Outcomes	11	How the initial improvement plan evolved over time (if it did), including alternative change strategies considered and rejected, with reasons; how and why this evolution occurred and who was responsible for it. What effects the changes/improvements actually had on clinical and/or organizational and professional outcomes and processes including benefits, harms, unexpected results, problems, failures.
Discussion
Summary	12	Key findings, lessons learned from evolution of changes, outcomes achieved.
Context	13	Comparison and contrast of results with the findings of others; broad formal review of the literature is desirable.
Interpretation	14	Inferences about mechanisms of changes/improvements, including prior changes, change making in this setting.
Limitations	15	Sources of bias or imprecision; factors affecting generalizability, particularly unique features of local setting, and potential confounders; efforts made to minimize and correct for limitations; effect of limitations on interpretation and application of results.
Conclusions	16	Implications for practice and further study; plans for maintenance of improvement and for follow up to assess maintenance; next steps.

*Although each section of the text of a quality improvement report in the Introduction, Methods, Results, and Discussion (IMRaD) format (for example, the Introduction) generally needs to contain at least some information about all of the guidelines items listed for that section, individual items from 1 guideline section are often needed in various sections of the text.

STARD Flowchart of Diagnostic Test Results O

Reference: Bossuyt P, et al, for the STARD Steering Group: Towards complete and accurate reporting of studies on diagnostic accuracy. BMJ 326:41-44, 2003 (freely available at bmj.bmjjournals.com/cgi/reprint/326/7379/41)

Recommended Format for the Reporting of Studies on Diagnostic Accuracy According to the STARD Group O

Paper Section and Topic	Item #	Description
Title, Abstract, & Keywords	1	Identify the article as a study of diagnostic accuracy (recommend MeSH heading “sensitivity and specificity”).
Introduction	2	State the research questions or aims, such as estimating diagnostic accuracy or comparing accuracy between tests or across participant groups.
Methods
Participants	3	Describe the study population: the inclusion and exclusion criteria and the settings and locations where the data were collected.
	4	Describe participant recruitment: was this based on presenting symptoms, results from previous tests, or the fact that the participants had received the index tests or the reference standard?
	5	Describe participant sampling: was this a consecutive series of participants defined by selection criteria in items 3 and 4? If not, specify how patients were further selected.
	6	Describe data collection: was the data collection before the index tests and reference standard were performed (prospective study) or after (retrospective study)?
Test methods	7	Describe the reference standard and its rationale.
	8	Describe technical specifications of material and methods involved, including how and when measurements were taken, or cite references for index tests or reference standard, or both.
	9	Describe definition and rationale for the units, cut-off points, or categories of the results of the index tests and the reference standard.
	10	Describe the number, training, and expertise of the persons executing and reading the index tests and the reference standard.
	11	Were the readers of the index tests and reference standard blind (masked) to the results of the other test? Describe any other clinical information available to the readers.
Statistical methods	12	Describe methods for calculating or comparing measures of diagnostic accuracy, and the statistical methods used to quantify uncertainty (eg, 95% confidence intervals).
	13	Describe methods for calculating test reproducibility, if done.
Results
Participants	14	Report when study was done, including beginning and ending dates of recruitment.
	15	Report clinical and demographic characteristics (eg, age, sex, spectrum of presenting symptoms, comorbidity, current treatments, recruitment center).
	16	Report how many participants satisfying the criteria for inclusion did or did not undergo the index tests or the reference standard, or both; describe why participants failed to receive either test (a flow diagram is strongly recommended) .
Reference standard	17	Report time interval from index tests to reference standard, and any treatment administered between.
	18	Report distribution of severity of disease (define criteria) in those with the target condition and other diagnoses in participants without the target condition.
Test results	19	Report a cross tabulation of the results of the index tests (including indeterminate and missing results) by the results of the reference standard; for continuous results, report the distribution of the test results by the results of the reference standard.
	20	Report any adverse events from performing the index test or the reference standard.
Estimation	21	Report estimates of diagnostic accuracy and measures of statistical uncertainty (eg, 95% confidence intervals).
	22	Report how indeterminate results, missing responses, and outliers of index tests were handled.
	23	Report estimates of variability of diagnostic accuracy between readers, centers, or subgroups of participants, if done.
	24	Report estimates of test reproducibility, if done.
Discussion	25	Discuss the clinical applicability of the study findings.

i. Clinical Trial: A clinical trial is an experimental study that assesses the effect of an intervention or compares the effects of 2 or more interventions. Reporting guidelines vary according to the design:

iii. Case Series: A case series is a retrospective description of the clinical course of several individuals or patients. Unlike an observational study, a case series may or may not have a predictor.

CONFLICT OF INTEREST POLICY

Title & Abstract

Introduction

Methods

Results

Discussion

Item #

Methods

Adapted with permission; © 2004 BMJ Publishing Group Ltd.

Recommended Format for Reporting of Noninferiority and Equivalence Trials According to the CONSORT Group O

Discussion

Adapted with permission; © 2006 American Medical Association.

Title & Abstract

Introduction

Methods

Randomization

Results

Adapted with permission; © 2006 American College of Physicians.

Paper Section and Topic

Descriptor (items in italics are specifically added, modified, or further emphasized from CONSORT checklist for RCTs of parallel group design, since they are relevant for reporting behavioral interventions using nonrandomized experimental designs)

Title & Abstract

Introduction

Scientific background and explanation of rationale.

Theories used in designing behavioral interventions.

Methods

Results

Discussion

Adapted with permission; © 2004 American Public Health Association.

Paper Section and Topic

Item #

Paper Section and Topic

Item #

Paper Section and Topic

Item #

Title

Introduction

Methods

Results

Discussion

Adapted with permission; © 1999 Elsevier.

Adapted with permission; © 2000 American Medical Association.

Adapted with permission; © 2005 BMJ Publishing Group Ltd.

Description

Introduction

Methods

Results

Discussion