Transcript Document

Writing, Submitting, and
Publishing Your Research
Daniel G. Haller, MD
Professor of Medicine
University of Pennsylvania
Philadelphia PA USA
Editor-in-Chief Emeritus, Journal of Clinical Oncology
Editor-in-Chief, Gastrointestinal Cancer Research
Co-editor, 3rd edition Oxford Textbook of Oncology
No Disclosures
Goals
Learn how to
• Identify the appropriate journal
• Meet submission requirements
• Learn about authorship, conflict of interest, conduct and
misconduct
• Assess and ensure the quality of your manuscript
• Navigate the peer-review process
Examine Your Research
• What is the purpose of your research?
• Who should read about it?
• What are the implications of your research for
readers?
Look for the journal whose scope
and readers’ interests correspond to your
research question and key message.
Examine the Journal
Elements to Investigate
• Topics Covered
• Readership Interests
 who is the audience?
• Standing in the Community
 It’s not all about the Impact Factor
• International Distribution (print and online)
Examine the Journal
Other Considerations
• Subscriber Level
 Readership may far exceed subscriptions
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Online Exposure
Author and Publication Fees, if any
Time to Publication
Publication Frequency
Free-Access Policy
What Type of Journal Is Right?
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General Medical Journals (NEJM, Lancet, BMJ)
Clinical Practice (JCO)
Experimental Research (Cancer Research)
Review Journal (Cancer Treatment Reviews)
Cross-Disciplinary (Journal of the NCCN)
Subspecialty (Annals of Surgical Oncology,
Journal of Thoracic Oncology)
JCO Welcomes Many Article Types
Submissions by Article Type
2009
2010
Original Reports
3,299
3,309
Review Articles
168
158
Editorials, Comments and Controversies
166
125
Correspondence/replies
540
483
Art of Oncology
54
72
Diagnosis in Oncology
647
617
All material, all types
4,974
4,854
JCO Covers the Oncology Spectrum
Original Report Submissions by Cancer Type
2009
2010
Breast
473
447
Hematologic Malignancies
358
394
Gastrointestinal
381
356
Genitourinary
233
214
Thoracic
204
208
Pediatric
151
145
Gynecologic
146
110
Head and neck
94
92
Selected JCO Articles Are Published in
International Editions
Chinese
Czech/Slovak
French
German
Greek*
Hungarian
Indian*
Italian
Japanese
*English
Middle Eastern*
North African*
Polish
Romanian
Russian
South African*
Spanish
Turkish
JCO Original Report Acceptance Rates
3500
3,299
3000
3,317
Original Reports
2,994
2500
2,799
2000
Submitted
Accepted
1500
1000
500
550
577
680
596
0
Acceptance Rates
2007
20%
2008
19%
2009
21%
2010
18%
Impact Factor: Calculation
• An example of a recent impact factor (IF) measured citations in 2009 to
papers published in 2007 and 2008, divided by the number of items
published in 2007 and 2008.
• The IF is a mean, not a median.
• Therefore, a single highly cited article may skew the IF, especially if the total
number of published articles is low (e.g. CA-A Journal for Clinicians, US
cancer statistics January issues)
• Citations in 2009 to items published in:
2007 – 13,724
2008 – 13,624
Total: 27,348
Number of items published in:
20072008 Total:
771
766
1,537
27,348
= 17.793
1,537
Impact factor:
Selected Oncology Journals
Journal
Impact Factor
2010
Articles in 2010
Journal of Clinical Oncology
18.970
784
Lancet Oncology
17.764
108
Journal National Cancer Institute
14.697
135
Blood
10.558
1,280
Cancer Research
8.234
1,052
Clinical Cancer Research
7.338
629
Annals of Oncology
6.452
445
The Oncologist
5.826
180
Cancer
5.131
632
International Journal of Cancer
4.926
588
Authorship
Criteria, Recognition and
Responsibility
Authorship
Many journals adhere to the authorship guidelines established
by the International Committee of Medical Journal Editors
(ICMJE).
www.icmje.org/ethical_1author.html
ICMJE Criteria
An author must meet all three of the following criteria:
1) Contribute to the study in one of three ways:
a) Conception and Design
b) Acquisition of Data
c) Analysis and Interpretation of Data
2) Draft or revise the article for important intellectual
content.
3) Approve the final version.
(continued)
Responsibility of Authorship
Journal editors do not make authorship decisions or
arbitrate conflicts related to authorship.
Authors alone are responsible for resolving any conflicts.
There is only one first author, and one
corresponding author (who may be the same)
Acknowledgments
• Typically, an online list of all contributors who do not
meet criteria for authorship, including
– Those who provided purely technical help or writing assistance
– “We thank John Smith, MD, and Jane Clarke, MD, for excellent
technical assistance.”
– Colleagues who read the manuscript and gave advice
– “We thank Sean D. Jones, PhD, for critical reading of the manuscript.”
– A department chairperson who provided only general support
– List groups of participants under headings such as Clinical Investigators
or Participating Investigators or by contributions such as data collection
or scientific advising.
– Unfortunately, acknowledgments do not appear as a Pubmed citation.
(continued)
Acknowledgments
• If someone other than the authors has assisted in writing the
paper (such as a science writer or corporate employee), you must
disclose that participation, including financial support.
– “We thank Lucy Hurst (iMed Comms) for medical writing assistance
and iMed Comms for editorial assistance in formatting,
proofreading, copy editing, and fact checking, with funding provided
by Shire.”
– This is not the same as ghostwriting.
• List financial and material support for the study.
– Patients and materials were provided by Amgen.
– This study was supported by the Northern California Oncologists
Association.
Ethical Standards
in Publishing
Issues and Practices for Authors and Journals
Disclosing Potential Conflicts
Conflicts often concern financial relationships with:
• pharmaceutical and biotechnology companies
• device manufacturers
Common financial relationships that need to be disclosed include:
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employment
consultancy work
honoraria
paid expert testimony
speakers’ bureaus of research sponsors
stock ownership
(continued)
Disclosing Potential Conflicts
• Review the Conflict of Interest policy of the journal
and prepare the disclosure forms as required.
• Create a Conflicts of Interest section in the
manuscript to state whether any potential conflicts
of interest exist.
• Disclose all relationships that are potential conflicts.
– If you are unsure whether a conflict exists, it is better to include
the relationship.
Disclosing Potential Conflicts
• Potential conflicts should be disclosed to individuals
studied (typically in the consent form)
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Include a note in the manuscript that you have done so.
• Disclosure does not typically disqualify the manuscript
from being published.
• Most journals publish disclosures (both in print and
online) so readers can make their own judgment about
potential bias.
(continued)
Disclosing Potential Conflicts
• If you used a service (e.g., writing/editing) to prepare
the manuscript, disclose the funding source for this
assistance on the title page.
• If your study received support, indicate whether the
sponsor had a role in the following:
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Designing the study
Collecting, analyzing, or interpreting the data
Writing the manuscript
Deciding where to submit the manuscript for publication
Author Misconduct
Author misconduct may include, but is not limited to:
• Fabrication or falsification of data
• Plagiarism (including self-plagiary)
• Redundant publication of content
 Electronic journals allow for reader access to the literature,
thereby eliminating need for republication in separate
journals.
• Duplicate submission
(continued)
Author Misconduct
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Failure to credit an author
Inappropriate credit to an author
Submission of ghostwritten manuscripts
Failure to disclose potential conflicts of interest
Author misconduct does not include honest errors, which
journals may correct by publishing errata.
Data Fabrication/Falsification
Data fabrication or falsification may include but is not
limited to:
• Inventing and reporting nonexistent data (or entire
studies/manuscripts)
• Altering research materials/methods, protocols, data,
or results
• Taking any action that obscures scientific truth
Plagiarism
Plagiarism is claiming someone else’s work or ideas as your own, or
copying your own prior work, including use of the following without
formal permission and acknowledgment of the source:
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Text
Tables
Figures
Photographs
Data
Other work from another publication
Redundant Publication
Redundant (or duplicate) publication occurs when a newly
published article overlaps substantially with an already published
article, including:
 Reusing your own previously published work without
acknowledging the source
• Using previously published data without acknowledging the
source
• Writing numerous articles from the same data set if the data
are divided into units too small to warrant publication
(continued)
Redundant Publication
The following do not typically jeopardize publication:
• Presentation of an abstract or poster at a scientific
meeting (beware of embargo policies)
• Publication of an abstract or press release about the
abstract
• Registration with an ICMJE-approved clinical trial
registry, or entry of data into a registry
Ghostwriting
Ghostwriting occurs when someone originates or makes substantial
contributions to the manuscript but is not listed appropriately as an
author or in the Acknowledgment section.
• All contributors who participate in the study or in manuscript
development must be disclosed, including:
• Employees of pharmaceutical companies or device
manufacturers
• Medical writers
• Junior faculty at an author’s institution
Journal Integrity
Journals take concerns about the integrity of their
publications very seriously.
• Most journal follow COPE guidelines: COPE provides
advice to editors and publishers on all aspects of
publication ethics and, in particular, how to handle
cases of research and publication misconduct
(http://publicationethics.org/about)
• If author misconduct is alleged or suspected, an
investigation will be conducted.
(continued)
Journal Integrity
If misconduct is verified or admitted, journals may place
sanctions on authors.
• Sending an official letter of reprimand to the authors of
a submitted manuscript or published article
• Informing the authors’ institution(s) and/or the
institution where the research was performed about
the misconduct)
(continued)
Journal Integrity
 Restricting the authors from publishing in the journal
for a specified period of time
 Rejecting future manuscripts submitted by the authors
 Retracting the authors’ articles
 Publishing a statement of concern about the authors’
articles
 Retractions and statements of concern are posted in
Pubmed
Elements of an Effective
Original Report
Writing Key Sections
Effective Writing
• ABC: Accuracy, Brevity, Clarity
• The editors’ questions:
 Is it new?
 Is it true?
 Will it affect the practice of oncology?
Before Writing
• Avoid writing multiple articles using the same
research unless new data are substantial.
 “Salami science”
 The “LPU” = least publishable unit
• Avoid claims of novelty or originality, unless you’re
sure it’s true
 Pubmed exists….editors and authors use it
How to Report Research
 State the problem or pose your question.
 Present evidence and demonstrate its validity.
 Discuss initial implications and provide additional evidence.
 Assess conflicting evidence or trial limitations.
 State the implications of your work clearly.
 Mention your new direction of research.
• For phase II trials, state whether phase III trials are planned
or underway.
Abstract
• State your research question, rationale for the study, methods,
and conclusions.
• Include only the most important data.
• Use the same level of technical language as in the main text of
the article; avoid jargon.
• Check that all content is consistent with the main text of the
article.
• Avoid understating toxicities.
• Do not overstate results.
 These are marks of ghostwriters
Results
• Report statistically insignificant differences objectively.
• Avoid creating new metrics (e.g., “a significant trend was
seen”).
• When possible, use figures and tables to present data
without repeating the same data in text
 “Toxicities were similar between the treatments, except for neuropathy,
which was 31% in arm B and 1% in the control arm” (Table 3)
Discussion
 Avoid repeating material from your Introduction and
Results sections.
 Avoid exaggerating the implications of the study.
 Explain any weaknesses in your methods.
 Emphasize the importance of your work on the basis
of the results.
 Be cautious in making broad or firm
recommendations for clinical practice.
Statistical Guidelines
Best Practices for Planning
and Reporting Your Research
High Standards Required
• Journals such as JCO have biostatistical editors and
reviewers who ensure accurate statistical reporting.
• JCO conducts biostatistical reviews as needed and for
every randomized phase II/III trial under
consideration.
• JCO requires submission of a redacted protocol for
randomized phase II/III trials, including the entire
statistical section (more later…).
CONSORT
Consolidated Standards of Reporting Trials
(CONSORT)
www.consort-statement.org
When you are comparing two or more groups, create a CONSORT
diagram.
(continued)
REMARK
Reporting Recommendations for Tumor Marker
Prognostic Studies
(REMARK)
For biomarker studies, follow REMARK guidelines:
 McShane LM, Altman DG, Sauerbrei W, et al: Reporting
recommendations for tumor marker prognostic studies. J Clin
Oncol 23:9067-9072, 2005
 Alonzo TA: Standards for reporting prognostic tumor marker
studies. J Clin Oncol 23:9053-9054, 2005
(continued)
Additional Checklists
Microarray and Proteomic Data: MIAME
Brazma A, Hingamp P, Quackenbush J, et al: Minimum information about
a microarray experiment
(MIAME): Towards standards for microarray data. Nat Genet 29:365-371,
2001
Simon R, Radmacher MD, Dobbin K, et al: Pitfalls in the use of DNA
microarray data for diagnostic and prognostic classification. J Natl Cancer
Inst 95:14-18, 2003
Diagnostic Tests: GRADE
Shünemann HJ, Oxman AD, Brozek J, et al: Grading quality of evidence
and strength of recommendations for diagnostics tests and strategies.
BMJ 336:1106-1110, 2008
Additional Checklists
Meta-Analyses of Observational Studies: MOOSE
Stroup DF, Berlin JA, Morton SC, et al: Meta-analyses of observational
studies in epidemiology: A proposal for reporting. JAMA 283:2008-2012,
2008
Standards for the Reporting of Diagnostic Accuracy Studies:
STARD
Bossuyt PM, Reitsma JB, Bruns DE, et al: Towards complete and accurate
reporting of studies of diagnostic accuracy: The STARD initiative. Ann Intern Med
138:40-44, 2003
Meta-Analyses of Randomized Trials: QUORUM
Moher D, Cook DJ, Eastwood S, et al: Improving the quality of reports of
meta-analyses of randomised controlled trials: The QUORUM statement.
Lancet 354:1896-1900, 1999
Submission Preparation for
Original Research
Common Requirements of Journals
Clinical Trial Registration
 Most journals, including JCO, require that clinical trials
be registered.
 ICMJE defines a clinical trial as:
“Any research study that prospectively assigns human participants
or groups of humans to one or more health-related interventions
to evaluate the effects on health outcomes.”
 Be prepared to provide the identification number and
the URL for the trial's registry.
(continued)
Clinical Trial Registration
 If you are uncertain whether trial registration is
necessary, it is always better to register.
 Registration cannot be done retroactively.
 Compliance with registration requirements (i.e.
description of trial) does not jeopardize publication of
the manuscript.
 Studies with results posted in clinical trial registries are
not considered previously published (or in abstract or
press releases).
Peer-Review Process
Understanding Common Practices
Peer-Review Process
Review times differ among journals. At JCO, the editors
and editor-in-chief will typically make a decision, on the
basis of at least two reviews, within four weeks.
Outright acceptance is rare, so be prepared to make
changes and explain your work if the journal invites
revision.
Standard Decision Letters
Standard Decisions
 Rejection (w/o review)
 Major Revision
 Minor Revision
 Acceptance
Authors may
receive any of
these decisions at
any time in the
review process.
Reject Decision
Journals reject manuscripts for many reasons.
JCO’s most common list of reasons for rejection include:
 The subject does not fit the broad scope of JCO.
 The article is more appropriate for the audience of
another journal.
 The topic and results are of interest, but not novel and
sufficiently covered in the literature.
(continued)
Reject Decision
 The findings are too preliminary.
 The article gives insufficient evidence for the
conclusions.
 The science is weak or incomplete as described.
 The methods are unclear or unsound.
 The findings are not applicable to oncology practice.
 The priority is low relative to other articles being
considered.
Appealing a Rejection
If you feel strongly that the editors or reviewers misinterpreted
your manuscript, you may choose to appeal.
Address the rebuttal telephone call, email or letter to the editor
and do the following:
 Use courteous language and a polite tone.
 Explain why your article is a good fit for the journal.
 Include a detailed response to the critiques.
 Send the letter in a timely manner.
(continued)
Appealing a Rejection
 Rebuttals may take time.
 The editor may decide to send the manuscript out again for peer
review to the original or new peer reviewers.
 It is difficult to overturn a rejection decision, so it is sometimes
better to submit to a new journal. Discuss this with coauthors
and editors.
 However, a successful resubmission to the original journal can
still be faster than submission to a new journal.
Accept Decision
• All authors may need to complete additional forms,
such as copyright forms.
• Additional items may be needed, such as:
– High-resolution original-source figure files
– Glossary terms
• Most journals require transfer of copyright.
– You give the journal exclusive legal rights to use the content
of your article.
– Copyright transfer is a binding legal agreement.
– Read the agreement carefully, because terms differ among
journals.
Publicity and Embargo
• Adhere to the journal’s embargo policy, which restricts public
release of information about the article until it is published.
– Make sure the journal knows about an embargo date set for
after an abstract is presented.
• Authors are free to participate in press conferences or other
publicity activities once the embargo has lifted.
• If you are planning publicity, contact the journal for media
guidelines.
Final Acceptance
• Congratulations…you made it!
• Judiciously inquire as to the expected publication date.
• The online publication date is the official date for
referencing.
• Update your CV.