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AJKD 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.
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 considers only 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 of 300
words or fewer and is limited to 3,500 words (excluding abstract, references,
acknowledgements, tables, and figure legends). Criteria for review include
validity, originality, and clinical importance. A list of study designs
follows; flowcharts and checklists from the listed reporting guidelines are
provided in Appendix I.
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.
○ Randomized Controlled Trial
(RCT): The CONSORT Flowchart should
be consulted for reporting participant flow through enrollment, allocation, follow-up,
and analysis. Customized CONSORT checklists are available in Appendix I for each of the study types listed below.
- Trial with Parallel
Group Design
- Noninferiority and Equivalence Randomized Trial
- Trial of Herbal
Medicine Intervention
- Trial
of Nonpharmacologic Treatment
Note: If
appropriate, the CONSORT
Checklist for Reporting of Harms in RCTs should
also be consulted.
○ Nonrandomized Trial for Evaluation of Behavioral and Public
Health Interventions: The TREND Checklist should be
consulted for reporting guidance.
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.
○ Cohort Study: STROBE Checklist
for Cohort Studies
○ Case-Control Study: STROBE
Checklist for Case-Control Studies
○ Cross-sectional Study: STROBE
Checklist for Cross-sectional Studies
○ Gene-Disease Association Study:
STREGA Checklist for Genetic Association Studies
iii. 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 consulted for reporting participant flow through
enrollment, testing, and results and the STARD Checklist should
be consulted for format recommendations.
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: QUOROM Meta-analysis of RCTs Checklist
o
Meta-analysis of Observational Studies:
MOOSE
Meta-analysis of Observational Studies Checklist
o
Meta-analysis of Gene-Disease
Association Studies:
- Sagoo GS, Little J, Higgins JPT. Systematic Reviews of
Genetic Association Studies. PLoS Med. 2009;6(3):e1000028.
doi:10.1371/journal.pmed.1000028 (PDF freely available)
- Human Genome Epidemiology Network Review Handbook (PDF freely
available at www.genesens.net/_intranet/doc_nouvelles/HuGE%20Review%20Handbook%20v11.pdf)
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 consulted:
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,
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. The SQUIRE
Checklist provides guidance on
reporting.
vii. Case Series: A case series is a
retrospective description of the clinical course of more than 10 individuals or
patients. Unlike an observational study, a case series may or may not have a
predictor.
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 (up to 200 words) is required. Case Reports consist of an
Introduction, Case Report, and Discussion. The number of individuals or
patients should be 10 or fewer. Criteria for review include clinical
plausibility and originality. A maximum of 8 authors is generally recommended.
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 include originality, comprehensiveness, and balance of viewpoints. The
editors encourage the use of figures and tables (up to 8 combined) to assist in
the presentation of the central concepts. An abstract (up to 200 words) is
required. A maximum
of 6 authors is generally recommended.
Editorials provide focused commentary and
analysis concerning a topic of interest to AJKD
readers. These articles may have 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. A maximum of 3 authors is
generally recommended.
Letters to the Editor may be in response to an article
in AJKD or may concern a topic of current
interest in nephrology. For responses to AJKD
articles, the letter must be received no more than 4 weeks after the article’s
date of print publication. The body of the letter should be as concise as
possible and generally should not exceed 250 words. In general, 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 (up to 200 words).
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. A maximum of 4 authors is generally recommended.
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 4 subsections: Clinical
History and Initial Laboratory Data, Kidney Biopsy, Diagnosis, and Clinical Follow-up), and
Discussion. A maximum of 4 authors is generally recommended.
Acid-Base and
Electrolyte Teaching Case: A case report to educate clinicians on the pathophysiology of
various acid-base and electrolyte disorders and the interpretation of laboratory
studies. Each case is chosen specifically to
emphasize either diagnosis or treatment of a particular disorder and to
illustrate the most efficient and practical approach utilized by an expert in
the field. 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. An abstract is not
needed. The case discussion should be divided into the following sections: Introduction,
Case Report (with 4 subsections: Clinical History and Initial Laboratory
Data, Additional Investigations, Diagnosis, and Clinical Follow-up), and Discussion. A maximum of
4 authors is generally recommended.
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 4 subsections: Clinical History and Initial
Laboratory Data, Imaging Studies, Diagnosis, and Clinical Follow-up), and
Discussion. A maximum of 4 authors is generally recommended.
In Translation: An authoritative 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. A maximum of 6 authors is generally
recommended.
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. Submissions should be 4,000
words or fewer, and an abstract (up to 200 words) is required. A maximum of 6
authors is generally recommended.
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.
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.
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 2008; 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.
In accordance with International Committee of Medical
Journal Editors recommendations, all authors must have a significant role in
the manuscript. This means that all 3 of the following conditions must be met:
(1) the individual made a
substantial contribution to conception and design of the study, to data
acquisition, or to data analysis and interpretation; and
(2) the individual wrote the article
and/or revised the article for important intellectual content; and
(3) the individual approved the
final version of the submitted manuscript.
Note: If the manuscript is subsequently accepted, the individual
must also approve the final version that is accepted for publication.
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. In particular, if medical writer(s)/ editor(s) have
been involved, their role must be explicitly acknowledged, and their
affiliation/source of funding must be listed.
At the editor’s discretion, a description of the
contribution of each individual listed as an author may be requested by the
journal.
All manuscripts are submitted
and processed using Editorial Manager, an electronic manuscript handling system
accessible at www.editorialmanager.com/ajkd. Assistance
with Editorial Manager is available from the editorial office staff, who may be
contacted at +1 617-636-0599 or AJKD@tuftsmedicalcenter.org.
Manuscript Length and Text Format
Word
limits are provided in the “Categories of
Articles” section. If following the recommended formats for reporting
original research causes the manuscript to exceed the stated length limitation,
the authors need not reduce the manuscript length before submission. If
revision is requested, the editors will provide guidance on appropriate
reductions or the use of supplementary online material.
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 individuals listed as authors must fulfill the journal’s
definition of authorship. 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 are 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 |
|
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 |
|
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 |
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 (PDF freely available).
Manuscript Body
Original Investigations should
be organized into the following sections: Introduction, Methods, Results, and
Discussion. The Introduction and Discussion sections should not include any
subheadings. In writing each section, authors should refer to the recommended
formats for reporting as described in Appendix I of this document.
Information on the organization of other article types is
available in the individual article descriptions in the “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 named in this section. Authors are responsible for
informing all listed individuals/parties that they are being mentioned in the manuscript
and for 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;
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.
Book
chapter:
Batlle D. Metabolic acidosis. In: Greenberg
A, ed. Primer on Kidney Diseases. 2nd
ed.
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
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 conversion factors for
international units, 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 Material 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 material file(s) should be provided at the time of
manuscript submission, and should be called out in the text (eg, Table S2, Fig
S1, Item S4). 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 material will generally be corrected for style,
grammar, and format. Information on copyright assignment for supplementary material
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 generally
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.
For Original Investigations,
Special Articles, Narrative Reviews, and Editorials, units should be expressed
in US conventional units throughout; international equivalents or conversions
are not necessary in running text (the abstract and body of the manuscript).
However, conversion factors must be provided in figure legends and table notes,
as appropriate.
For a complete list of values
requiring unit conversions in tables and figures, as well as the conversion
factors, authors may consult the Unit Converter (Appendix
II
and in the For Authors section of
the AJKD website).
Examples for Original Investigations, Special Articles, Narrative Reviews, and Editorials
In text:
In text (no
conversion provided): Serum creatinine
at 3 months was 9.62 mg/dL.
In figure
legends:
Conversion
factors for units: serum creatinine in mg/dL to mol/L, ×88.4; urea nitrogen in
mg/dL to mmol/L, ×0.357. No
conversion necessary for serum potassium in mEq/L and mmol/L, ferritin in ng/mL
and μg/L, and PTH in pg/mL and ng/L.
In tables:
|
|
Patient 1 |
Patient 2 |
|
Serum creatinine |
0.6 mg/dL |
1.2 mg/dL |
|
Serum urea nitrogen |
8 mg/dL |
18 mg/dL |
|
Serum sodium |
140 mEq/L |
141 mEq/L |
Note: Conversion
factors for units: serum creatinine in mg/dL to mol/L, ×88.4; serum urea
nitrogen in mg/dL to mmol/L, ×0.357. No conversion necessary for serum sodium
in mEq/L and mmol/L.
For Case Reports, Teaching
Cases, Letters, and case-related content (eg, a clinical vignette), units of measurement should be
expressed in US conventional units, with international units provided in
parentheses.
Examples for Case Reports, Teaching Cases, and Letters
In text:
In text: Serum creatinine at 3 months was 0.62 mg/dL
(54.8 µmol/L).
In figure
legends:
Conversion
factors for units: serum creatinine in mg/dL to mol/L, ×88.4; urea nitrogen in
mg/dL to mmol/L, ×0.357. No
conversion necessary for serum potassium in mEq/L and mmol/L, ferritin in ng/mL
and μg/L, and PTH in pg/mL and ng/L.
In tables:
|
|
Patient 1 |
Patient 2 |
|
Serum creatinine |
0.6 mg/dL |
1.2 mg/dL |
|
Serum urea nitrogen |
8 mg/dL |
18 mg/dL |
|
Serum sodium |
140 mEq/L |
141 mEq/L |
Note: Conversion
factors for units: serum creatinine in mg/dL to mol/L, ×88.4; urea nitrogen in
mg/dL to mmol/L, ×0.357. No conversion necessary for serum sodium in mEq/L and
mmol/L.
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.
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, editorial expression of concern, or editorial.
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.
Copyright Transfer
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.
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APPENDIX I: RECOMMENDED
FORMATS FOR REPORTING BY STUDY DESIGN
The CONSORT Participant Flowchart O
Reference: Egger
et al, for the CONSORT Group: Value of flow diagrams in reports of randomized controlled
trials. JAMA 285:1996-1999, 2001
(freely available at jama.ama-assn.org/cgi/reprint/285/15/1996)
Recommended Format for Reporting of Randomized Controlled Trials With
Parallel Group Design According to the CONSORT Group O
|
Section |
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 Allocation
concealment Implementation |
8 9 10 |
Method used to generate the random
allocation sequence, including details of any restriction (eg, blocking,
stratification). Method used to implement the random
allocation sequence (eg, numbered containers or central telephone),
clarifying whether the sequence was concealed until interventions were
assigned. 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% CI). |
|
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. |
Adapted with
permission; © 2001 American
Recommended Format for Reporting of Cluster-Randomized Trials
According to the CONSORT Group O
|
Section |
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 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 Allocation
concealment Implementation |
8 9 10 |
Method used to generate the random
allocation sequence, including details of any restriction (eg, blocking,
stratification, matching). 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. 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% CI) 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. |
Adapted with
permission; © 2004 BMJ Publishing Group Ltd. Reference: Campbell 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)
Recommended
Format for Reporting of Noninferiority and Equivalence Trials According to the
CONSORT Group O
|
Section |
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 Allocation
concealment Implementation |
8 9 10 |
Method used to generate the random
allocation sequence, including details of any restriction (eg, blocking,
stratification). Method used to implement the random
allocation sequence (eg, numbered containers or central telephone),
clarifying whether the sequence was concealed until interventions were
assigned. 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 CI 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% CI). For the
outcome(s) for which noninferiority or equivalence if hypothesized, a figure
showing CIs 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. |
Adapted with
permission; © 2006 American Medical Association. Reference: Piaggio 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)
Recommended
Format for Reporting of Randomized Controlled Trials of Herbal Medicine
Interventions According to the CONSORT Group O
|
Section |
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. |
|
Adapted with
permission; © 2006 American
Recommended
Format for Reporting of Pragmatic Trials According to the CONSORT and Pragmatic
Trials in Healthcare Groups O
|
Section |
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). |
|
Introduction |
||
|
Background |
2 |
Scientific background and explanation
of rationale. Describe the health or
health service problem that the intervention is intended to address and other
interventions that may commonly be aimed at this problem. |
|
Methods |
||
|
Participants |
3 |
Eligibility criteria for participants
and the settings and locations where the data were collected. Eligibility criteria should be explicitly
framed to show the degree to which they include typical participants and/or,
where applicable, typical providers (eg, nurses), institutions (eg,
hospitals), communities (or localities, eg, towns) and settings of care (eg,
different healthcare financing systems). |
|
Interventions |
4 |
Precise details of the interventions
intended for each group and how and when they were actually administered. Describe extra resources added to (or
resources removed from) usual settings in order to implement intervention.
Indicate if efforts were made to standardize the intervention or if the
intervention and its delivery were allowed to vary between participants,
practitioners, or study sites. Describe
the comparator in similar detail to the intervention. |
|
Objectives |
5 |
Specific objectives and hypotheses. |
|
Outcomes |
6 |
Report 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). Explain why the chosen
outcomes and, when relevant, the length of follow up are considered important
to those who will use the results of the trial. |
|
Sample size |
7 |
How sample size was determined and,
when applicable, explanation of any interim analyses and stopping rules. If calculated using the smallest
difference considered important by the target decision maker audience (the
minimally important difference) then report where this difference was
obtained. |
|
Randomization Sequence
generation Allocation
concealment Implementation |
8 9 10 |
Method used to generate the random
allocation sequence, including details of any restriction (eg, blocking,
stratification). Method used to implement the random
allocation sequence (eg, numbered containers or central telephone), clarifying
whether the sequence was concealed until interventions were assigned. 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
blinding was not done, or was not possible, explain why. |
|
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 (a diagram is strongly recommended)—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. The number of participants or
units approached to take part in the trial, the number which were eligible,
and reasons for nonparticipation should be reported. |
|
Recruitment |
14 |
Dates defining the periods of
recruitment and follow up. |
|
Baseline data |
15 |
Baseline demographic and clinical
characteristics for 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% CI). |
|
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. Describe key
aspects of the setting which determined the trial results. Discuss possible
differences in other settings where clinical traditions, health service
organization, staffing, or resources may vary from those of the trial. |
|
Overall
evidence |
22 |
General interpretation of the results
in the context of current evidence. |
Adapted with permission; © 2008 BMJ
Publishing Group Ltd. Reference: Zwarenstein et al, for the CONSORT and
Pragmatic Trials in Healthcare (Practihc) groups: Improving the reporting of
pragmatic trials: an extension of the CONSORT statement. BMJ 337:a2390, 2008 (freely available at www.bmj.com/cgi/reprint/337/nov11_2/a2390.pdf)
Recommended Format for Reporting of Randomized Controlled Trials
of Nonpharmacologic Treatments According to the CONSORT Group O
|
Section |
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). In the abstract, description of the
experimental treatment, comparator, care providers, centers, and blinding
status. |
|
Introduction |
||
|
Background |
2 |
Scientific background and explanation
of rationale. |
|
Methods |
||
|
Participants |
3 |
Eligibility criteria for participants
and the settings and locations where the data were collected. When applicable, eligibility criteria for
centers and those performing the interventions. |
|
Interventions |
4 |
Precise details of the interventions
intended for each group and how/when they were actually administered. Precise details of both the experimental
treatment and comparator. (a) Description of the different components of the
interventions and, when applicable, descriptions of the procedure for tailoring
the interventions to individual participants. (b) Details of how the
interventions were standardized. (c) Details of how adherence of care
providers with the protocol was assessed or enhanced. |
|
Objectives |
5 |
Specific objectives and hypotheses. |
|
Outcomes |
6 |
Report 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. When applicable, details of whether and
how the clustering by care providers or centers was addressed. |
|
Randomization Sequence
generation Allocation
concealment Implementation |
8 9 10 |
Method used to generate the random
allocation sequence, including details of any restriction (eg, blocking,
stratification). When applicable, how
care providers were allocated to each trial group. Method used to implement the random
allocation sequence (eg, numbered containers or central telephone),
clarifying whether the sequence was concealed until interventions were
assigned. Who generated the allocation
sequence, who enrolled participants, and who assigned participants to their
groups. |
|
Blinding
(masking) |
11A 11B* |
Whether or not participants, those
administering the interventions, and those assessing the outcomes were
blinded to group assignment. Whether or
not those administering co-interventions were blinded to group assignment. If
blinded, method of blinding and description of the similarity of
interventions.* |
|
Statistical
methods |
12 |
Statistical methods used to compare
groups for primary outcome(s); methods for additional analyses, such as
subgroup analyses and adjusted analyses.
When applicable, details of whether and how the clustering by care providers
or centers was addressed. |
|
Results |
||
|
Participant
flow |
13 |
Flow of participants through each
stage (a diagram is strongly recommended)—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. The number of care providers
or centers performing the intervention in each group and the number of
patients treated by each care provider or in each center. |
|
Implementation
of intervention |
(new) |
Details
of the experimental treatment and comparator as they were implemented. |
|
Recruitment |
14 |
Dates defining the periods of recruitment
and follow up. |
|
Baseline data |
15 |
Baseline demographic and clinical
characteristics for each group. When
applicable, a description of care providers (case volume, qualification,
expertise, etc) and centers (volume) in 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% CI). |
|
Ancillary
analyses |
18 |
Address multiplicity by reporting any
other analyses performed, including subgroup 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. Also, take into account the choice of the
comparator, lack of or partial blinding, and unequal expertise of care
providers or centers in each group. |
|
Generalizability |
21 |
Generalizability (external validity)
of the trial findings according to the
intervention, comparators, patients, and care providers and centers involved
in the trial. |
|
Overall
evidence |
22 |
General interpretation of the results
in the context of current evidence. |
*This item
anticipates a planned revision in the next version of the standard CONSORT
checklist.
Adapted with
permission; © 2008 American
Recommended Format for the
Reporting of Harms in Randomized Controlled Trials According to the CONSORT
Group O
|
Section |
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). If the study collected data on harms and
benefits, the title or abstract should so state. |
|
Introduction |
||
|
Background |
2 |
Scientific background and explanation
of rationale. If the trial addresses
both harms and benefits, the introduction should so state. |
|
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). 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 |
How sample size was determined and,
when applicable, explanation of any interim analyses and stopping rules. |
|
Randomization Sequence
generation Allocation
concealment Implementation |
8 9 10 |
Method used to generate the random
allocation sequence, including details of any restriction (eg, blocking,
stratification). Method used to implement the random alloca |