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Jeffrey Robens, PhD Senior Research Consultant
Education Group Leader
Writing a Clinical Research Paper that has Impact
The 67th Annual Scientific Meeting of the
Japanese Association for Thoracic Surgery
30 September 2014
Be an effective communicator
S
Your goal is not only to be published, but also to be widely read/cited
Good experimental design
Logically present your work in your manuscript
Choose the best journal to reach your target audience
Convey the significance of your work to journal editors
Section 1
Good experimental design
Experimental design
What do international journal editors want?
Interesting to journal’s readership
Increase impact
High quality research
Original and novel research Well-designed study
Transparent reporting Clinical applications
Experimental design
What do international journal editors want?
Clinical relevance
Technical quality
Novelty
Surgical resections of 500 Japanese lung
cancer patients
Experimental design
What do international journal editors want?
Clinical relevance
Technical quality
Novelty
Surgical resections of younger and older Japanese
lung cancer patients
Experimental design
Clinical research that has impact
1. Read primary literature
2. Read systematic reviews and meta-analyses
3. Identify an important question
• Is the question focused? • Do you have the expertise/resources? • What is new? • How is it clinically useful?
Experimental design Clinical trial registration
Not required for observational studies
Retrospective registration is sometimes possible
Should be registered before journal submission
Treatments/interventions are not assigned by the investigator
Where to register? ClinicalTrials.gov
UMIN Clinical Trials Registry (umin.ac.jp)
Experimental design Publication ethics
Conflicts of interest
Plagiarism
Author contribution
Data fabrication or falsification
Consequences of unethical behavior
• Unable to publish • Loss of employment
Section 2
Manuscript structure
Manuscript structure Reporting guidelines
CONSORT Randomized clinical trials
PRISMA Systematic reviews &
Meta-analyses
CARE Case reports
STROBE Observational studies
http://www.equator-network.org/ http://www.equator-network.org/library/translations-of-reporting-guidelines/#Japanese
Manuscript structure Writing clinical abstracts
Background Why does this trial/case
need to be reported?
Results Treatment outcomes
Adverse events
Conclusion Clinical relevance Learning points
Patients and methods
Patient information Interventions given
Concise summary of your study
List source of funding and trial registration number after abstract
Manuscript structure Introduction
General introduction
Specific aims Aims
Current state of the field
Problem in the field
Manuscript structure Specific aims
Aims
…we examined the effect of the severity of kidney dysfunction on the risks of death, cardiovascular events, and hospitalization among a large, diverse group of adults.
Problem …whether chronic kidney disease independently increases the risk of any type of cardiovascular disease has not been established. In addition, few studies have investigated the association between chronic kidney disease and the risk of hospitalization…
Identify an important problem State aims that directly address this problem
Go et al. N Engl J Med. 2004; 351: 1296–1305.
Manuscript structure Methods
How the study was done
Treatments (controls) Patient management
Follow-up
Quantification methods Statistical tests
Consult a statistician
Participants used
Demographics Enrollment procedure
Inclusion/exclusion criteria
Data analysis
Study design
Manuscript structure Results
1. Study design 2. Treatment efficacy 3. Safety
Each subsection corresponds to
one figure
What you found, not what it means
Logical presentation
Subsections
Factual description
Manuscript structure Discussion
Summary of findings
Relevance of findings
Clinical implications
Similarities/differences Unexpected results Negative results Limitations
Manuscript structure
Writing a strong conclusion
Why your study is important
In conclusion, we found an independent, graded association between lower levels of the estimated GFR and the risks of death, cardiovascular events, and hospitalization. These risks were evident at an estimated GFR of less than 60 ml per minute per 1.73 m2 and substantially increased with an estimated GFR of less than 45 ml per minute per 1.73 m2. Our findings support the validity of the National Kidney Foundation staging system for chronic kidney disease but suggest that the system could be further refined, since all persons with stage 3 chronic kidney disease (GFR, 30 to 59 ml per minute per 1.73 m2) may not be at equal risk for each outcome. Our findings highlight the clinical and public health importance of chronic kidney disease that does not necessitate dialysis.
Conclusion
Key finding
Implications
Future directions
Clinical importance
Go et al. N Engl J Med. 2004; 351: 1296–1305.
Manuscript structure Linking your ideas
General background
Objectives
Methodology
Results and figures
Summary of findings
Clinical implications
Clinical relevance
Problem in the field
Logically links your ideas throughout your manuscript
Current state of the field Introduction
Methods
Results
Discussion
Section 3
Communicating with journals
Coverage and Staffing Plan
Communicating with journals Evaluating significance
How new are your findings? Low vs. high impact journal
Novelty
How broadly relevant are your findings? International/regional & general/specialized
Relevance
What are the important clinical implications? Appeal
Coverage and Staffing Plan
Communicating with journals Factors to consider
Aims & scope Readership
Open access Impact factor
Which factor is most important to you?
Indexing
Coverage and Staffing Plan
Communicating with journals
Dear Dr Lippman,
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 an Original Article in the Breast
Cancer Research and Treatment.
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 Breast Cancer Research and Treatment 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
A good cover letter
We would also like to suggest the following reviewers for our manuscript…
Editor’s name Manuscript title
Publication type
Recommend reviewers
Publication ethics disclaimers
Coverage and Staffing Plan
Communicating with journals
Disclaimers about publication ethics
“Must-have” statements
Not submitted to other journals
Registration Informed consent
Authors agree on paper/journal
Original and unpublished
Conflicts of interest/funding
Authorship contributions
Additional forms: CONSORT/STROBE statements
Acceptance checklist
Well-designed study with proper controls
Publically registered trial
Logically organized manuscript
Appropriate journal selection
Cover letter (+ CONSORT/STROBE)
Any questions?
Thank you!
Jeffrey Robens: [email protected]
Downloads and further reading
www.edanzediting.co.jp/jats_2014
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