Shahrokh F. Shariat , MD Chair and Professor, Medical University of Vienna, Vienna, AUT
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Clinical research original article: How to write an article and get it published
in European UrologyShahrokh F. Shariat, MD
Chair and Professor, Medical University of Vienna, Vienna, AUT
Adjunct Professor, Weill Cornell Medical University and New York Presbyterian Hospital, New York, USA
Adjunct Professor of Urology, UT Southwestern, Dallas, Texas, USA
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Remember the
purpose of your
manuscript
…is to inform
Introduction
Materials & Methods
Results
Discussion
Conclusions
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Introduction
Materials & Methods
Results
Discussion
Conclusions
A single piece of work
• Keep it joined together• One section should flow
into the next
• NO SURPRISES
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• Clearly and simply explain – what the research question is– why it is relevant, why it is original– very briefly how it will be answered
Introduction section
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• Summarize other relevant papers in orderly
fashion (logic) to set the background– Not be an in-depth literature review
Introduction section
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• An excellent study has an obviously important and
original question, and therefore needs only brief
introduction.
– Make it short: 250-500 words,
~3-4 paragraphs,
1 page
Introduction section
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• 1st paragraph: brief background in present tense to establish context, relevance, or nature of the problem, question, or purpose (what we know)
• 2nd paragraph: importance of the problem and unclear issues (what we do not know - gap in knowledge - why it is important to fill that gap)
• 3rd paragraph: rationale, hypothesis, main objective, or purpose (why the study was done - hypothesis for how you will fill that gap in knowledge).
Introduction section
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Introduction section
1st paragraph:
brief background on
radical cystectomy and
role of lymph node
dissection
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Introduction section2nd paragraph: importance of the problem and unclear issues (minimal number of LN to remove, anatomical extent of LND, role of pT stage as predictor of LN involvement)
3rd paragraph: rationale, hypothesis, main objective
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• Usually not easy for inexperienced authors
• Writing intro last can prevent writer’s block and is
easier
Introduction section
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• M&M section is the core of each paper• Describes - study design,
- how it was performed, and
- data analysis• Provides all elements to allow others to reproduce the study• Easiest part of manuscript• Writing this section of the paper in the most complete way
before starting the study can help to discover methodological biases in a moment when they are easily fixed!
Methods section
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• Period of enrolment/evaluation• Type of study (retrospective; prospective; controlled;
randomized)• Inclusion criteria / patient selection• Exclusion criteria / reasons to exclude patients• Details on used materials or technique - report in detail original methods/techniques
- cite (and reference) known methods• Ethical issues
What methods section should include
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http://www.equator-network.org/home/
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http://www.equator-network.org/home/
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http://www.equator-network.org/home/
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Methods section in RCT – CONSORT statement
www.consort-statement.org
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Methods section
IRB approval
Quality control
Inclusion/exclusion criteria
Description of pathology procedure
Clinical setting
TNM staging system
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• Study results
- by definition, they go in the “Results” section
• Comments
- on patients characteristics, indications, inclusion and
exclusion criteria they go in the “Discussion” section
What methods section should NOT include
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Results• Describe final population
• Patient details
• Describe intervention
• Treatments
• Observations
• Describe outcomes
• Survival
• Disease related
• Toxicities
• Others
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Discussion• Summarize your main findings
• Compare your data with previous reports
• Describe & explain discrepancies
• Where do your findings sit in our world
• Where are they going to take us
• What next ….
• Limitations and concerns
• Final conclusions
The discussion should place your findings into the scientific literature
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Results: General design
• Patient population(s)• Treatment(s) received
• Outcomes in each group• Good and Bad findings
• Comparisons between groups• Analysis of each factor/predictive features
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Results – Using figures and tables
Text
Tables
Figures
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Text
Tables Figures
They should integrate together
Need all three components
to understand the paper
But … a reader should be
able to follow paper using
just tables and figures
So … make the legends
descriptive and include all
necessary findings
Results – Using figures and tables
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Results
• Be clear about your study ….. what is it? Observational Retrospective or prospective Single or Multi-institutional Data quality Screening Randomized or other
• Whilst Result organization is broadly similar ... each may require different reporting details
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Results
CONSORT Guidelines = A good place to start- Participant flow
Initial participants
Final participantsTypically Table 1. = Details of participants
Figure 1. = Flow chart- What time period?
Consecutive or selected patientsFiltered cases or “all comers”
- Institutions –How many from each?
http://www.consort-statement.org/
Why excluded?
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Table 1. Details of patients and treatments
The purpose of this table is to allow a reader to use your data:Clinicians:1. Do the cases represent the disease?2. Are the patients the same as mine?3. Can I identify how to treat a patient in clinic?Researchers:4. Can I use your data to compare with my results 5. Can I incorporate these into a meta-analysis6. Can I use these data for new research?Patients:7. Have I been treated correctly?8. Is there a better doctor for me?
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How to report data?
Continuous datae.g. Age, PSA ….Show range, distribution and variability
Mean and standard deviation, if normally distributedMedian and ranges (25th and 75th centiles), if not
Ordinal or nominal datae.g. stage or gradeTreat as individuals (not as continuous data)Shown number and proportions for each
Compare populations, if relevantAre the patients or the disease the same in each arm?
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Figure 1. Flow chart of patients/studies/interventions
Keep it as simple as possible
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Results: Outcomes - reporting and analysis
In general:
- The results should match the primary and
secondary outcomes (as stated in M&M)
- Use paragraphs/sections for each outcome
- Intention to treat analysis is more robust (as it
avoids bias of losses or excluded cases)
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Methods
Results
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Methods
Results
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Results: Outcomes - reporting and analysis
• Report outcomes for each
arm/population
• Table 2. typically report appropriate
details (mean/median & St. Dev or
Ranges)
• Use confidence intervals (95% CI)
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Results – Survival outcomes
Be precise ….
1. Are you describing death or survival
Disease specific survival vs. Disease specific mortality
2. What are you describing?
Overall survival (death all causes) vs. Non-disease
specific survival (death from other causes) or competing
mortality vs. disease specific survival
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Results – Treatment outcomes
Be precise …. in your terminology1. Bladder cancer behavior
Recurrence, Progression, Relapse ….2. Prostate cancer treatment
PSA recurrence – Post surgery, Post ADT, Post radiotherapy
3. Incontinence outcomes Pads, further treatment, QOL outcomes
4. etc.
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Results – Treatment outcomes
Be precise ….
Use Objective measures where possible
use of another treatment (salvage radiotherapy)
worsening radiology or pathology
Try to avoid clinician based outcomes “progression” or
“failure” with no supporting data
Use blinded outcomes where possible
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Results – Treatment outcomes
Be precise …. Use Important outcomes (to the patient, clinician,
researcher, society, healthcare provider … )
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Results – Treatment outcomes
Be precise …. Use Realistic outcomes
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Results – Compare outcomes: Specifics
Use the appropriate test
For the Data:
Distribution: Normal or not
Data: Continuous or interval outcomes
Binary or many intervals
Nominal data
Beware of too few cases
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Results – Compare outcomes: Specifics
Use the appropriate test
For the Outcome:
Inter group comparisons
Relative and absolute outcomes
Survival analysis
Competing mortality
Numbers needed to treat
Adjustments for trial design
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Results – Compare outcomes: Specifics
Use the appropriate test For the Context:
Univarbiable vs. MultivariablePrognostic vs. Predictive
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Results – Compare outcomes: General concepts
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Results – Compare outcomes: General concepts
Statistical vs. clinical significance
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Results: Further analysis
Typical to look at sub-group analysis or analysis of variables in later sectionsMaybe the most interesting findingsAgain … be realistic with your dataPresent analyses clearly and logicallyDo not look for analysis where the data are missing Do not perform analysis that are not justifiedKeep the reader with you
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Discussion
• Briefly summarize your findings• Answer your initial question
• Briefly mention previous reports and compare your data these reports• Explain differences – you may both be right!
• Place your findings into the field• How important are they?• How strong can your conclusions be?• How does this change patient care/treatments etc.?• Where next with this field/work ….
• Limitations and shortcomings: Be critical and open with limitations … it makes the data more believable and the paper stronger
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Discussion: Common issues and faults
• Too long • Too many points addressed
• Too many comparisons and in too much detail• Incoherent or illogical organization
• Poor flow, changing directions, back and forth ….
• Write on paper a plan and stick to it
• Discussion that is not supported by the data• Not addressing major inconstancies with the field
• Too limited discussion of weaknesses etc.
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The final check1. Do you clearly state/explain and answer your main question?2. Have you explained the novelty and importance of this work? Is it
clear for someone outside the field?3. Rigor and presentation:
We are trusting that you have done this work/reported the outcomesIf you can not be bothered to present/edit/check the paper properly …. then have you really treated 2,500 men consistently ?
4. Consistency: Abstract vs. main bodyTables & figures vs. main text
5. Are your conclusions justified?