130628 Japan Breast Cancer Society
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Transcript of 130628 Japan Breast Cancer Society
Jeff Robens, PhDSenior Editor
Publishing clinical research:Increasing your chances of acceptance
Japan Breast Cancer Society28 June 2013
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Section One: Experimental design
Section Two: Manuscript structure
Section Three: Communicating with journals
Today’s presentation …
Section 1
Experimental design
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Experimentaldesign Clinical trial design
Only studies with approved protocols are likely to be accepted for publication
Trial type• Randomized controlled trial• Observational• Single/double-blind
Controls • Active comparator• Placebo-controlled
Well-outlined protocol
Experimentaldesign
Clinical trial registration
Declaration of Helsinki: “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.”
WHO: “The registration of all interventional trials is considered to be a scientific, ethical and moral responsibility…”
ICMJE: “The ICMJE member journals will require, as a condition of consideration for publication in their journals, registration in a public trials registry.”
This includes all interventional trialsClinicalTrials.gov
www.umin.ac.jp/ctr/index-j.htm
Experimentaldesign
Clinical trial registration
Not required for observational studies
Retrospective registration is often possible
Should be registered before journal submission
Treatments/interventions are not assigned by the investigator
Experimentaldesign Publication ethics
Declare conflicts of interest
Don’t plagiarize
Proper author contribution
Don’t fabricate or falsify data
Consequences of unethical behavior
• Unable to publish• Loss of employment
Section 2
Manuscript structure
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Manuscriptstructure
Structuring your ideas
General background
Objectives
Methods
Results and figures
Summary of findings
Implications for the field
Relevance of findings
Knowledge gaps
Logically links your ideas throughout your manuscript
Current state of the fieldIntroduction
Methods
Results
Discussion
Manuscriptstructure Structure of ideas
Molecular markers help clinicians manage metastatic breast cancer systemically by indicating when endocrine therapy, chemotherapy, or HER2–targeted therapy
(such as trastuzumab or lapatinib) is appropriate.
However, previous studies have suggested the possibility of discordant HER2 status between primary and metastatic tumors.
Furthermore, to the best of our knowledge, there have been no previous studies evaluating
whether clinical factors affect these discordance rates.
Aims: Determine the discordance rates of HER2 in primary and metastatic tumors and determine if they are influenced by trastuzumab and/or chemotherapy
Niikura et al. J Clin Oncol 2011; 30: 593–599.
Manuscriptstructure Structure of ideas
Aims: Determine the discordance rates of HER2 in primary and metastatic tumors and determine if they are influenced by trastuzumab and/or chemotherapy
Importance of biomarkers for determining appropriate therapy
Potential difference between primary and metastatic tumors
Not known what causes this difference
Study objectives
Niikura et al. J Clin Oncol 2011; 30: 593–599.
Manuscriptstructure
Writing clinical abstracts
Background Why was this trial conducted or why does this case need to be reported?
Patient information
Age, gender, ethnicity, enrollment procedure/ eligibility criteria
Observations Treatment outcomes, adverse events
Conclusion Clinical impact, learning points
Interventions/Treatment
Treatment given, patient management, follow-up
Manuscriptstructure
What is publishable?
New or emerging disease
New treatment or diagnosis
Unusual presentation of
disease
New or unusual adverse effect of
treatment
Case studies
Manuscriptstructure
Case reports – essential elements
Short, 500–1500 words Write simply and concisely
Don’t use “he” and “she” when referring to patient’s family members or other patients
Needs to have educational value in addition to novelty
Kukreja et al. BMJ Case Reports 2011.
Manuscriptstructure
Background Concise description of the disease or treatment
Case presentationPatient information
Diagnostic tests and resultsInterventions
Follow-up
DiscussionInterpret the findings
Relationship with other casesImplications for the field
Case reports – structure of ideas
• Clinical implications• Educational value• Future directions
Section 3
Communicating with journals
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Coverage and Staffing Plan
Communicating with journals
Before writing Title, Abstract, Introduction, Discussion, and References
Journal selection
After key results have been obtained
When to choosethe journal?
Coverage and Staffing Plan
Communicating with journals Factors to consider
Aims and scope Readership Open access Impact factor Publication type
Which factor is most important to you?
Coverage and Staffing Plan
Communicating with journals
Evaluating significance
How new are your findings?Incremental or conceptual advances?Novelty
How broadly relevant are your findings?Population or geographically specific? Relevance
What are the important real-world applications?Can they be used now to treat patients?Appeal
Coverage and Staffing Plan
Communicating with journals Journal Selector
Input your abstract or selected keywords
Filter your results
Coverage and Staffing Plan
Communicating with journals
What do journal editors want?
Interesting to journal’s readership
Increase impact
High quality research
Original and novel research Clear and concise
English
Coverage and Staffing Plan
Communicating with journals
Dear Dr Harris,
Please find enclosed our manuscript entitled “Evaluation of the Glasgow prognostic score in patients undergoing curative resection for breast cancer liver metastases,” which we would like to submit for publication as a Full Paper in the British Journal of Cancer.
The Glasgow prognostic score (GPS) is of value for a variety of tumours. Several studies have investigated the prognostic value of the GPS in patients with metastatic breast cancer, but few studies have performed such an investigation for patients undergoing liver resection for liver metastases. Furthermore, there are currently no studies that have examined the prognostic value of the modified GPS (mGPS) in these patients. The present study evaluated the mGPS in terms of its prognostic value for postoperative death in patients undergoing liver resection for breast cancer liver metastases.
A total of 318 patients with breast cancer liver metastases who underwent hepatectomy over a 15-year period were included in this study. The mGPS was calculated based on the levels of C-reactive protein and albumin, and the disease-free survival and cancer-specific survival rates were evaluated in relation to the mGPS. Prognostic significance was retrospectively analyzed by univariate and multivariate analyses. Overall, the results showed a significant association between cancer-specific survival and the mGPS and carcinoembryonic antigen level, and a higher mGPS was associated with increased aggressiveness of liver recurrence and poorer survival in these patients.
This study is the first to demonstrate that the preoperative mGPS, a simple clinical tool, is a useful prognostic factor for postoperative survival in patients undergoing curative resection for breast cancer liver metastases. This information is immediately clinically applicable for oncologists treating such patients. As a premier journal covering the broad field of cancer, we believe that the British Journal of Cancer is the perfect platform from which to share our results with the international medical community.
Give the background to the research
What was done and what was found
Interest to journal’s readers
Cover letters
We would also like to suggest the following reviewers for our manuscript…
Editor’s name Manuscript title
Publication type
Recommend reviewers
CONSORT or STROBE checklists
Coverage and Staffing Plan
Communicating with journals
CONSORT –clinical studies
Optimize reporting of randomized controlled trials (RCTs)
www.consort-statement.org
Coverage and Staffing Plan
Communicating with journals
CONSORT –clinical studies
Recommended flow chart of the passage
of participants through an RCT
www.consort-statement.org
Coverage and Staffing Plan
Communicating with journals
STROBE –observational studies
Strengthening the reporting of observational studies in epidemiology
Five available checklists
• Cohort studies• Case-control studies• Cross-sectional studies• Combined• Conference abstracts
www.strobe-statement.org
Acceptance checklist
Well-designed study with proper controls Publically registered trial Well-written manuscript Appropriate journal selection Cover letter (+ CONSORT or STROBE checklists)
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