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`Media Center
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`The New England Journal of Medicine (NEJM) employs a
`rigorous peer review and editing process to evaluate all
`manuscripts for scientifc accuracy, novelty, and importance.
`This painsaking publication process has been tesed over many
`decades and is a major reason for the Journal’s reputation as
`the world’s leading medical journal.
`
`NEJM receives over 4,500 original research submissions each
`year — more than a dozen each business day — with over half
`coming from outside the U.S.
`
`At leas fve experts review and edit each Original Article or
`Special Article manuscript published by NEJM. Of thousands of research reports submitted each year, about
`5% are eventually published by NEJM.
`
`The peer review process works to improve research reports while preventing oversated results from reaching
`physicians and the public. Each published NEJM manuscript benefts from hundreds of hours of work by
`editors, satisical experts, manuscript editors, illusrators, proofreaders, and production personnel, who work
`
`https://www.nejm.org/media-center/publication-process[1/13/2021 5:45:26 PM]
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`to ensure that every paper meets exacting sandards.
`
`About the Editors
`
`The NEJM core editorial team comprises nine physician editors and one Ph.D. geneticis.
`
`Drs. Eric J. Rubin (Editor-in-Chief), Edward W. Campion (Executive and Online Editor), and Mary Beth
`Hamel (Executive Deputy Editor) lead and direct the work of seven deputy editors, nine associate editors,
`and the Perspective editor.
`
`Deputy Editors
`
`NEJM deputy editors — mos of whom also spend some portion of their time in patient care, medical
`research, or teaching — manage non-research content appearing in NEJM. They also serve key roles in the
`research review process, ensuring that no manuscript under review by NEJM can be declined without the
`agreement of at leas two NEJM editors.
`
`Associate Editors
`
`Nine NEJM associate editors are chosen for their expertise in major areas of medicine. Associate editors play
`central roles in managing the peer review process and in decisions to accept or decline manuscripts for
`publication in NEJM. In addition to their work for NEJM, they also hold full-time positions at academic
`medical centers.
`
`The Path of a Research Manuscript
`
`NEJM Executive Deputy Editor Mary Beth Hamel, M.D., M.P.H., reviews each research manuscript
`submission and determines whether it meets essential NEJM criteria to warrant further consideration and
`peer review. About 10% of submitted papers are declined at this sage without further editorial consideration.
`
`A paper passing Dr. Hamel’s initial review moves to an appropriate associate editor, who
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`determines whether it meets fundamental criteria for:
`Quality
`Novelty
`Potential clinical impact
`
`If so, the associate editor sends the manuscript to at leas two peer reviewers.
`
`Should an associate editor wish to decline a paper without peer review, it goes frs to a deputy editor for a
`second opinion; if the deputy editor disagrees with the associate editor, the paper will be sent on for peer
`review.
`
`Peer Review
`
`NEJM maintains a database of more than 30,000 peer reviewers worldwide in all areas of medicine. In
`almos all cases, two peer reviewers evaluate each submission within one to two weeks and submit written
`reports to the NEJM editors.
`
`During peer review, all manuscripts are considered privileged communications. Without prior
`approval from the NEJM editorial ofce, peer reviewers are expressly prohibited from:
`Copying manuscripts
`Sharing with others
`Discussing their personal evaluations or recommendations
`
`NEJM also insructs peer reviewers to:
`Report immediately any possible personal, professional, or fnancial conficts of interes with authors or
`related to a paper’s topic; where conficts arise, NEJM editors fnd subsitute reviewers.
`Desroy manuscript copies once reviews are complete.
`
`Full Editorial Team Review and Statisical Review
`
`Using peer reviews and their own judgments, NEJM associate editors then decide whether to decline a
`manuscript (a decision which mus be seconded by a deputy editor) or to bring it to a weekly editorial
`meeting attended by all NEJM deputy editors, associate editors, and satisical consultants for discussion and
`
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`debate.
`
`Following discussion at a weekly editorial meeting, a paper will be assigned one of three satuses:
`Rejection: Publication is declined; reviewers’ comments are provided to authors.
`Provisional Rejection: The manuscript is not suitable for publication unless the authors conduct further
`research or collect additional data.
`Revision: NEJM has interes in the paper, but the manuscript is not acceptable in its current form and mus
`be revised before further consideration for publication. If a manuscript is moved to Revision satus, the paper
`will be sent on for satisical review — an additional, rigorous review sep. Mos research manuscripts
`published by NEJM undergo at leas one satisical review by one of fve satisical consultants prior to
`acceptance.
`
`More on the Revision Process
`
`The associate editor communicates a paper’s satus to its authors in a letter detailing quesions raised in the
`review process and, where applicable, recommending revisions needed to meet NEJM sandards for
`publication. Authors respond to the associate editor with a revised manuscript and letter detailing their
`changes.
`
`When authors resubmit a revised manuscript, the associate editor again reviews it and decides whether
`further peer or satisical review is needed and often brings the paper back to a weekly editorial meeting for
`further discussion.
`
`If additional outside review is not needed, the manuscript will be sent to a deputy editor for additional editing
`and revisions in collaboration with the associate editor and its authors.
`
`Final Review & Acceptance for Publication
`
`The NEJM Editor-in-Chief reviews all fnal (revised) submissions and may raise further quesions. The
`Editor-in-Chief is the only person who can ofcially accept a paper for publication. Following Dr. Rubin’s
`formal acceptance for publication, a paper will then move through rigorous processes for manuscript editing,
`production, illusration, design, and publication.
`
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`
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`RESOURCES
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`
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`Publication Process | NEJM Media Center
`
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`Publication Process | NEJM Media Center
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`https://www.nejm.org/media-center/publication-process[1/13/2021 5:45:26 PM]
`
`AAA, Ex. 2005
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`
`
`Appendix 02
`Appendix 02
`
`AAA, Ex. 2005
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`AAA, Ex. 2005
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`
`
`12/29/2020
`NEJM — Author Center - What to Expect
`Go APR MAY JUN
`...__ ___________________________ ____, CJ
`http://www.nejm.org/page/author-center/publication-process
`07
`◄
`18 captures
`2015 2016 2017
`19 Oct 2014 - 18 Oct 2016
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`
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`f 🐦
`▾ About this capture
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`L
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`The NEW ENGLAND
`JOURNAL of MEDICINE
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`Author Center What to Expect
`
`Welcome and thank you for considering the New England Journal of Medicine (NEJM) as a venue for your work.
`Our mission since 1812 has been to bring physicians the best research at the intersection of biomedical science and
`clinical practice. We are interested in original research that will change clinical practice or teach us something new about
`the biology of disease. We also publish reviews, cases, commentary, and other content of interest to the medical
`community.
`
`The dedication of generations of researchers, authors, reviewers, and physician editors has made NEJM the most widely
`read and respected medical journal and website in the world, and the oldest continuously published medical periodical.
`Here are a few reasons why we hope you’ll decide to send us your best work:
`
`More than 600,000 readers in nearly every country in the world read NEJM each week.
`Our impact factor (Science Citation Index rating) was 54.420 in 2013, the highest among general medical journals.
`We publish only the top 5% of the 5,000 research submissions we receive each year, more than half of those coming
`from outside of the U.S.
`All research articles are freely available six months after publication, and we provide unrestricted online access at the
`time of publication to more than 115 low-income countries.
`We offer an expedited publication process for select papers and will respond to any pre-submission inquiry within one
`week.
`
`We have a highly-rigorous peer-review and editing process in which we evaluate manuscripts for scientific accuracy,
`novelty, and importance. Each article we publish benefits from hundreds of hours of work by physician editors, statistical
`experts, illustrators, manuscript editors, proofreaders, and production personnel, who work to ensure that it meets our
`exacting standards. This thorough work prior to publication is a major reason for our reputation as the “gold standard” for
`the latest research and best practices in medicine.
`
`What to Expect after Submission
`Our editor-in-chief will review your manuscript, and assign it to an associate or deputy editor with expertise in the field.
`That editor will evaluate whether the work meets our criteria for external peer review, which is conducted for about 40
`percent of the manuscripts papers. We use a standard, single-blind peer-review process, in most cases with at least
`two peer reviewers.
`Once the manuscript is back from review, the editors discuss it at a weekly meeting. If we are interested in a
`manuscript, it will be reviewed by one of our statistical consultants.
`The editor will work with you and your co-authors on the scientific meaning of the manuscript, and additional rounds of
`peer review and revision will occur until the manuscript is ready to accept.
`
`The Production Process
`Our expert manuscript editors will edit your manuscript’s English so that it will be understood by a worldwide audience
`of clinicians in all specialties.
`
`You will be sent two sets of proofs, and the schedule for their receipt will be provided to you soon after acceptance.
`
`1. At the galley stage, you will discuss changes with your manuscript editor, either on the phone or by e-mail.
`2. Then page proofs will be sent, giving you one additional chance to proofread your paper.
`
`The graphic arts department collaborates with authors and editors on figures, illustrations, animations and videos. If
`your paper has these items you will be contacted by an artist directly.
`We will notify you of your publication date and embargo schedule four weeks prior to publication. At that time we ask
`authors of research articles and commentary to provide contact information for the news media.
`Members of the news media will have access to your article and contact information one week prior to publication.
`They have agreed to respect our embargo schedule in exchange for this time to prepare their stories. We do not issue
`press releases or video news releases to our media subscribers. We welcome your academic institutions to send
`embargoed news releases regarding your work at this time.
`If an article is on a fast track and/or will be published Online First, all of the same steps will be taken, but the schedule
`will be compressed, which may mean a shorter turn-around time for authors’ proofs and media notification.
`
`Author Center Resources
`Author Center Home
`What To Expect
`How To
`Determine Your Article Type
`Prepare Your NEW Manuscript
`Prepare Your REVISED Manuscript
`Prepare Your Figures
`Prepare Your Supplementary Appendix
`Submit a Letter to the Editor
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`Ill, NEW ENGLAND JOURNAL oJ MEDICINE
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`1/2
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`NEJM — Author Center - What to Expect
`
`Go APR MAY JUN
`http://www.nejm.org/page/author-center/publication-process
`07
`After Publication
`' - - - - - - - - - - - - - - - - - - - - - - - - - - - - -~ C J
`◄
`18 captures
`Our regular issues are released on the web on Wednesday at 5:00 PM Eastern time. The print issue has a Thursday
`2015 2016 2017
`19 Oct 2014 - 18 Oct 2016
`date. Articles released Online First may have different release times.
`
`👤 ⍰ ❎
`
`
`f 🐦
`▾ About this capture
`
`Research published in NEJM receives extensive media coverage. You will find a list of your media coverage, as well
`as details on how many people saw your article, how it was downloaded, and where it has been cited since publication
`by typing the manuscript number into the tracking box on the Author Center Home Page.
`
`In addition to media coverage, NEJM promotes select content each week to a broader audience via many popular
`social media channels. Visit us on Facebook, Twitter, YouTube, Linked In and the Now@NEJM blog.
`
`CONTENT: Home Current Issue Articles
`Issue Index Specialties & Topics Multimedia & Images Archive 1812-1989
`I
`INFORMATION FOR: Authors Reviewers Subscribers
`Institutions Media Advertisers
`I
`SERVICES: Subscribe Renew Pay Bill Activate Subscription Create or Manage Account Alerts RSS & Podcasts Submit a Manuscript Mobile
`RESOURCES: Physician Jobs Reprints Permissions Medical Meetings Conventions FAQs NEJM Knowledge+ NEJM Journal Watch NEJM Catalyst Help Contact Us
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`Appendix 03
`Appendix 03
`
`AAA, Ex. 2005
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`AAA, Ex. 2005
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`
`
`New Manuscripts | NEJM Author Center
`
`Access provided by TATA MAIN HOSPITAL
`
`New England Journal of Medicine
`
`SUBSCRIBE
`OR RENEW
`
`~-----·~· ---l!I•"'-""""-
`. =
`'
`!
`-·-
`"
`~-=;.~ :
`
`
`
`New Manuscripts
`
`Author Center
`
`...,
`
`Welcome and thank you for considering the New England
`Journal of Medicine (NEJM) as a venue for your work.
`
`As the oldes continuously-published medical journal, our
`mission since 1812 has been to bring to physicians the bes
`research at the intersection of biomedical science and
`clinical practice. We are interesed in publishing original
`research that is desined to change clinical practice and
`teaches something new about the biology of disease. In
`addition to original research, NEJM publishes reviews,
`cases, commentary, and other content that is of interes to
`medical professionals.
`
`l Th, NEW ENGLAND JOURNAL of MEDICINE
`
`The dedication of generations of researchers, authors, reviewers, and physician editors has made NEJM
`the mos widely read and respected medical journal and website in the world.
`
`Submitting to NEJM
`
`https://www.nejm.org/author-center/new-manuscripts[12/29/2020 8:58:55 PM]
`
`AAA, Ex. 2005
`Page 12 of 27
`
`
`
`New Manuscripts | NEJM Author Center
`
`NEJM uses highly rigorous editorial, peer, and satisical review processes to evaluate manuscripts for
`scientifc accuracy, novelty, and importance.
`
`Step 1: Acquaint yourself with NEJM Editorial Policies, Article Types, options for
`Presubmission Inquiry and Rapid Review, Statisical Reporting Guidelines (if applicable), and
`key NEJM Style Elements.
`
`Step 2: Prepare materials for submission including cover letter (optional), main text, tables,
`fgures, supplementary appendix, clinical trial protocol and satisical analysis plan (if
`applicable).
`
`Step 3: Submit your manuscript to the NEJM online submission sysem by clicking on the red
`button at the top left hand side of this page.
`
`IMPORTANT TO NOTE
`Authors are expected to refrain from discussing the submission of their manuscript(s)
`(or the intention to submit) to NEJM with anyone, including colleagues and journaliss.
`The editors will also keep this information confdential.
`
`NEJM accepts the submission of manuscripts that have previously been posed on a
`nonproft preprint server. Authors should notify NEJM of any preprint related to a
`manuscript submission.
`
`Presubmission Options
`
`Mos NEJM article types are both solicited (invited by NEJM editors) and unsolicited (submitted at
`author discretion via the NEJM online manuscript submission sysem).
`
`PRESUBMISSION INQUIRY
`Authors unsure of the suitability of their manuscript for publication may save considerable time and
`efort by sending a Presubmission Inquiry. An NEJM editor will generally respond by email within one
`week.
`
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`
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`New Manuscripts | NEJM Author Center
`
`INVITED/COMMISSIONED ARTICLES
`Certain article types, including reviews and editorials, are usually solicited by NEJM editors in advance
`of submission. However, authors interesed in proposing ideas for these article types may also send
`Presubmission Inquiries.
`
`RAPID REVIEW
`Authors may reques a Rapid Review of their manuscripts. NEJM generally replies to Rapid Review
`requess within three business days and an initial decision on publication will typically be reached within
`two weeks.
`
`Those sudies that are mos often approved for a rapid peer review generally:
`Deal with urgent public health concerns
`•
`Have potential to dramatically change clinical practice or to afect mortality
`•
`Are timed to imminent meeting presentations
`•
`
`Approval for Rapid Review does not guarantee acceptance of the manuscript, nor does it guarantee
`expedited publication if the manuscript is accepted as each of these decisions is made separately.
`
`Statisical Reporting Guidelines
`
`Our Statisical Consultants recommend the following bes satisical practices in manuscripts submitted
`to the Journal. We recommend that you follow them in the design and reporting of research sudies.
`
`For all sudies:
`
`•
`
`•
`
`The Methods section of all manuscripts should contain a brief description of sample size and power
`considerations for the sudy, as well as a brief description of the methods for primary and secondary
`analyses.
`
`The Methods section of all manuscripts should include a description of how missing data have been
`handled. Unless missingness is rare, a complete case analysis is generally not acceptable as the primary
`analysis and should be replaced by methods that are appropriate, given the missingness mechanism.
`Multiple imputation or inverse probability case weights can be used when data are missing at random;
`model-based methods may be more appropriate when missingness may be informative. For the
`
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`Journal’s general approach to the handling of missing data in clinical trials please see Ware et al (N
`Engl J Med 2012;367:1353–1354).
`
`•
`
`Signifcance tess should be accompanied by confdence intervals for esimated efect sizes, measures of
`association, or other parameters of interes. The confdence intervals should be adjused to match any
`adjusment made to signifcance levels in the corresponding tes.
`
`•
`
`Unless one-sided tess are required by sudy design, such as in noninferiority clinical trials, all reported P
`values should be two-sided. In general, P values larger than 0.01 should be reported to two decimal
`places, and those between 0.01 and 0.001 to three decimal places; P values smaller than 0.001 should be
`reported as P<0.001. Notable exceptions to this policy include P values arising from tess associated
`with sopping rules in clinical trials or from genome-wide association sudies.
`
`•
`
`Results should be presented with no more precision than is of scientifc value and is meaningful given
`the available sample size. For example, measures of association, such as odds ratios, should ordinarily
`be reported to two signifcant digits. Results derived from models should be limited to the appropriate
`number of signifcant digits.
`
`For clinical trials:
`
`•
`
`•
`
`•
`
`Original and fnal protocols and satisical analysis plans (SAPs) should be submitted along with the
`manuscript, as well as a table of amendments made to the protocol and SAP indicating the date of the
`change and its content.
`
`The analyses of the primary outcome in manuscripts reporting results of clinical trials should match the
`analyses prespecifed in the original protocol, except in unusual circumsances. Analyses that do not
`conform to the protocol should be jusifed in the Methods section of the manuscript. The editors may
`ask for additional analyses that are not specifed in the protocol.
`
`When comparing outcomes in two or more groups in confrmatory analyses, invesigators should use the
`tesing procedures specifed in the protocol and SAP to control overall type I error — for example,
`Bonferroni adjusments or prespecifed hierarchical procedures. P values adjused for multiplicity should
`be reported when appropriate and labeled as such in the manuscript. In hierarchical tesing procedures, P
`values should be reported only until the las comparison for which the P value was satisically
`signifcant. P values for the frs nonsignifcant comparison and for all comparisons thereafter should not
`be reported. For prespecifed exploratory analyses, invesigators should use methods for controlling false
`discovery rate described in the SAP — for example, Benjamini–Hochberg procedures.
`
`•
`
`When no method to adjus for multiplicity of inferences or controlling false discovery rate was specifed
`
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`New Manuscripts | NEJM Author Center
`in the protocol or SAP of a clinical trial, the report of all secondary and exploratory endpoints should be
`limited to point esimates of treatment efects with 95% confdence intervals. In such cases, the Methods
`section should note that the widths of the intervals have not been adjused for multiplicity and that the
`inferences drawn may not be reproducible. No P values should be reported for these analyses.
`
`•
`
`•
`
`•
`
`•
`
`•
`
`Please see Wang et al (N Engl J Med 2007;357:2189–2194) on recommended methods for analyzing
`subgroups. When the SAP prespecifes an analysis of certain subgroups, that analysis should conform to
`the method described in the SAP. If the sudy team believes a pos hoc analysis of subgroups is
`important, the rationale for conducting that analysis should be sated. Pos hoc analyses should be clearly
`labeled as pos hoc in the manuscript.
`
`Fores plots are often used to present results from an analysis of the consisency of a treatment efect
`across subgroups of factors of interes. Such plots can be a useful display of esimated treatment efects
`across subgroups, and the editors recommend that they be included for important subgroups. If
`subgroups are small, however, formal inferences about the homogeneity of treatment efects may not be
`feasible. A lis of P values for treatment by subgroup interactions is subject to the problems of
`multiplicity and has limited value for inference. Therefore, in mos cases, no P values for interaction
`should be provided in the fores plots.
`
`If signifcance tess of safety outcomes (when not primary outcomes) are reported along with the
`treatment-specifc esimates, no adjusment for multiplicity is necessary. Because information contained
`in the safety endpoints may signal problems within specifc organ classes, the editors believe that the
`type I error rates larger than 0.05 are acceptable. Editors may reques that P values be reported for
`comparisons of the frequency of adverse events among treatment groups, regardless of whether such
`comparisons were prespecifed in the SAP.
`
`When possible, the editors prefer that absolute event counts or rates be reported before relative risks or
`hazard ratios. The goal is to provide the reader with both the actual event frequency and the relative
`frequency. Odds ratios should be avoided, as they may overesimate the relative risks in many settings
`and be misinterpreted.
`
`Authors should provide a fow diagram in CONSORT format. The editors also encourage authors to
`submit all the relevant information included in the CONSORT checklis. Although all of this
`information may not be published with the manuscript, it should be provided in either the manuscript or
`a supplementary appendix at the time of submission. The CONSORT satement, checklis, and fow
`diagram are available on the CONSORT website.
`
`For observational sudies:
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`The validity of fndings from observational sudies depends on several important assumptions, including
`those relating to sample selection, measured and unmeasured confounding, and the adequacy of methods
`used to control for confounding. The Methods section of observational sudies should describe how
`these and other relevant issues were managed in the design and analysis.
`
`•
`
`•
`
`If an observational sudy included a prespecifed SAP with a description of hypotheses to be tesed, a
`signed and dated version of that plan should be included with the manuscript submission. The Journal
`encourages authors to deposit SAPs for observational sudies in one of the online repositories designed
`for this purpose.
`
`When appropriate, observational sudies should use prespecifed accepted methods for controlling
`family-wise error rate or false discovery rate when multiple tess are conducted. In manuscripts reporting
`observational sudies without a prespecifed method for error control, summary satisics should be
`limited to point esimates and 95% confdence intervals. In such cases, the Methods section should note
`that the widths of the intervals have not been adjused for multiplicity and that the inferences drawn from
`the inferences may not be reproducible. No P values should be reported for these analyses.
`
`•
`
`If no prespecifed analysis plan exiss, the Methods section should provide an outline for the planned
`method of analysis, including
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`0
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`0
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`0
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`Eligibility criteria for the selection of cases and method of sampling from the data, with a diagram as
`appropriate.
`A description of the association or causal efect to be esimated and the rationale for this choice.
`The prespecifed method of analysis to draw inference about treatment or exposure efect or
`association.
`
`•
`
`•
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`Studies reporting the efect of a treatment or exposure should show the disribution of potential
`confounders and other variables, sratifed by exposure or intervention group. When the analysis depends
`on the confounders being balanced by exposure group, diferences between groups should be
`summarized with point esimates and 95% confdence intervals when appropriate.
`
`Complex models and their diagnosics can often be bes described in a supplementary appendix. Authors
`are encouraged to conduct an analysis that quantifes potential sensitivity to bias from unmeasured
`confounding; absent that, authors mus provide a discussion of potential biases induced by unmeasured
`confounders.
`
`•
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`Authors are encouraged to retes fndings in a similar but independent sudy or sudies to assess the
`robusness of their fndings.
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`Key Journal Style Elements
`
`UNITS OF MEASUREMENT
`Authors should express all measurements in conventional units, with Sysème International (SI) units
`given in parentheses throughout the text. Figures and tables should use conventional units, with
`conversion factors given in legends or footnotes. In accordance with the Uniform Requirements,
`however, manuscripts containing only SI units will not be returned for that reason.
`
`ABBREVIATIONS
`Except for units of measurement, abbreviations are srongly discouraged; the frs time an abbreviation
`appears, it should be preceded by the words for which it sands.
`
`DRUG NAMES
`Generic names should be used. When proprietary brands are used in research, include the brand name
`and the name of the manufacturer in parentheses after the frs mention of the generic name in the
`Methods section.
`
`Prepare Materials for Submission
`
`COVER LETTER
`Though cover letters are not required, the NEJM Online Submission sysem contains a text feld through
`which important information that is not in the metadata, such as a meeting presentation date or a major
`confict of interes not in the manuscript, should be communicated with initial manuscript submissions.
`
`MANUSCRIPT TEXT FILE
`Compile all text, references, fgure legends, and tables into a single double-spaced digital fle (preferably
`an MS Word document). NEJM will also accept text (.txt), or Rich Text Format (.rtf) fles.
`
`TITLE PAGE
`Create a title page that includes:
`Manuscript title
`•
`Each author’s name, highes degree, and afliation/insitution
`•
`Contact information for one corresponding author
`•
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`ABSTRACT
`Provide an absract of not more than 250 words with four labeled paragraphs containing the
`following:
`Background: Problem being addressed in the sudy
`•
`Methods: How the sudy was performed
`•
`Results: Salient results
`•
`Conclusions: What the authors conclude from sudy results
`•
`Trial regisration number
`•
`
`IDENTIFYING DATA
`At appropriate places in the manuscript, please provide the following items:
`If applicable, a satement that the research protocol was approved by relevant insitutional review boards
`•
`or ethics committees and that all human participants gave written informed consent
`Identities of those who analyzed the data
`For clinical trials, regisration number and regisry name (see: N Engl J Med 2004;351:1250-1)
`For sudies containing microarrays, accession numbers and repository name
`
`•
`•
`•
`
`REFERENCES
`References mus be double-spaced and numbered consecutively as they are cited. References
`frs cited in a table or fgure legend should be numbered so they will be in sequence with
`references