Clinical Writing for Interventional Cardiologists

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Clinical Writing for Interventional Cardiologists
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What you will learn

• Introduction
• General principles for clinical writing
• Specific techniques
• Practical session critical review of a published
  article
• Writing the Title and the Abstract
• Bibliographic search and writing the Introduction
• Principles of statistics and writing the Methods
• Practical session writing the Abstract
• Writing the Results
• Writing the Discussion
• Writing Tables and preparing Figures
• Principles of peer-review
• Principles of grant writing/regulatory submission
• Clinical writing at a glance
• Conclusions and take home messages

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What you will learn

• Writing the Results
• goals of Results
• effective tips

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Results
What were the findings? The answer is in the
Results.
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Expanded IMRAD algorithm
Introduction Background Limitations of
current evidence Study hypothesis Methods D
esign Patients Procedures Follow-up
End-points Additional
analyses Statistical analysis Results Basel
ine and procedural data Early
outcomes Mid-to-long term outcomes Addit
ional analyses Discussion Summary of study
findings Current research context Implic
ations of the present study Avenues for
further research Limitations of the present
study Conclusions
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Results

1. Logically answer the research question
2. Focus on primary endpoint and on additional data
   correlated to it
3. Correlate with the methods
4. Use data from this study only
5. Present all the representative data (with exact P
   values and confidence intervals)
6. Use tables, graphs, photographs, and drawings

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Results

• Show subject characteristics as n/N () and
  means SD (or median interquartile range)
• In an intervention
• show pre-test meansSD as subject characteristics
• show change-score meansSD to give an impression
  of any individual responses
• show differences in mean changes, with 95
  confidence intervals
• calculate any individual responses as a standard
  deviation

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Results

• Results should be simply stated (past tense)
• (Almost) never show test statistics (t, F, ?2)
• Avoid too much dryness and overwhelming the
  reader with data
• The mean resting blood pressure was 10 higher in
  the 30 tennis players than in the 20 control
  subjects (respectively 943 vs 855 mm Hg,
  P0.035).

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Results

• Results should be simply stated (past tense)
• (Almost) never show test statistics (t, F, ?2)
• Avoid too much dryness and overwhelming the
  reader with data
• The mean resting blood pressure was 10 higher in
  the 30 tennis players than in the 20 control
  subjects (respectively 943 vs 855 mm Hg,
  P0.035).
• The resting blood pressure was943 mm Hg in the
  30 tennis players vs 855 in the 20 controls
  (P0.035).

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Results

• Summarize multiple outcomes in a figure or table
• Avoid repetition of outcomes in figures, tables,
  or text
• Supplement rather than repeat data in visuals and
  tables
• Data must agree within the section and with data
  given in other sections and visuals
• MOST IMPORTANTLY Do not discuss the findings or
  interpret them qualitatively!

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Patient and procedural data
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Patient and procedural data
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Patient and procedural data
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Patient and procedural data
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Patient and procedural data
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Patient and procedural data
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Ancillary findings
In this case late loss (QCA based) was the
primary endpoint, thus priority to it (non
clinical ancillary endpoint)
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Ancillary findings
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Ancillary findings
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Primary Endpoint
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Ancillary findings
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Early outcomes
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Early outcomes
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Late outcomes
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Late outcomes
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Questions?
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What you will learn

• Introduction
• General principles for clinical writing
• Specific techniques
• Practical session critical review of a published
  article
• Writing the Title and the Abstract
• Bibliographic search and writing the Introduction
• Principles of statistics and writing the Methods
• Practical session writing the Abstract
• Writing the Results
• Writing the Discussion
• Writing Tables and preparing Figures
• Principles of peer-review
• Principles of grant writing/regulatory submission
• Clinical writing at a glance
• Conclusions and take home messages

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What you will learn

• Writing the Discussion
• goals of Discussion
• effective tips

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Discussion
What do these findings mean? The answer is in
the Discussion.
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Expanded IMRAD algorithm
Introduction Background Limitations of
current evidence Study hypothesis Methods D
esign Patients Procedures Follow-up
End-points Additional
analyses Statistical analysis Results Basel
ine and procedural data Early
outcomes Mid-to-long term outcomes Addit
ional analyses Discussion Summary of study
findings Current research context Implic
ations of the present study Avenues for
further research Limitations of the present
study Conclusions
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Discussion vs Results
Remember Results and Discussion sections
should appear as written by two different
people!
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Discussion

• Present the principles, relationships, and
  generalizations shown by the Results
• Briefly summarize the main findings in the first
  sentences
• But discuss not thoroughly recapitulate the
  Results
• Include a beginning, middle, and end
• Write in present tense, active voice - except for
  the findings, which are described in past tense
• Discuss this study only, in light of the others

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Discussion

• State the main finding, then explain how
  technicalities might have impacted it
• Interpret the magnitude of the main and any other
  findings qualitatively
• Reconcile the finding with those in other
  articles a qualitative mini meta-analysis if you
  will
• Explain possible mechanisms and confounders
• Devote space to discussion of a finding in
  proportion to the certainty of its magnitude
• Introduce no new results!
• Explain any major limitations

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Discussion

• Beginning
• Answer the research question
• Begin with a signal
• We found that
• Blood pressure increased in patients who
• Give emphasis to your strongest result!
• May use the a), b), c) approach

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Discussion

• Answer the question from the Introduction!
• End of Introduction
• ". . . to test whether abnormal distal run-off
  detected by angiographic frame count after
  primary PTCA, increases the likelihood of
  unfavorable cardiac remodeling"
• Beginning of the Discussion
• "This study shows that abnormal distal run-off,
  detected on angiographic frame count after
  primary PTCA, was associated with a major
  increase in the risk of unfavorable cardiac
  remodeling in patients with acute myocardial
  infarction.

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Discussion

• Middle
• Interpret your results
• Discuss key studies but only those relevant to
  your work
• Compare your work with others work
• Present ambiguous results and discrepancies with
  others objectively
• Explain unexpected findings
• Describe limitations
• Use subheadings (most of the times helpful)

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Discussion
Introduce Points With Your Findings Example In
this study, multivariate analysis revealed that
abnormal distal run-off was an independent
predictor of unfavorable remodeling. Levy et
al17 reported less striking differences However,
the retrospective nature of their study and the
uneven distribution of baseline clinical
characteristics in their patient population
could account for the relatively narrow
difference in their results.
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Discussion

• Compare With Earlier Work
• Own work first
• The fact that our study was prospective lends
  support to the evidence (1-3) of a causal role of
  coronary Doppler micro-hits on peri-procedural
  outcomes in coronary stenting.
• Others work first
• Previous studies on the clinical impact of
  coronary Doppler micro-hits on peri-procedural
  outcomes in coronary stenting have reported
  conflicting and inconclusive results Findings
  of this study further expand previous knowledge,
  showing that micro-hits have indeed a major
  clinical detrimental role, but this is restricted
  to patients without adequate collateralization of
  the target vessel. In addition, we found that

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Discussion

• Why using a structured format for the Discussion
• Helps organizing your writing
• Enhances readability
• Shows off that you follow a structured approach
  in everything you do

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Structuring the Discussion

• The usual structure of the Discussion is
• Brief summary of the study findings (no need for
  heading)
• Current research context (use as heading)
• Implications of the present study (use as
  heading)
• Avenues for further research (use as heading)
• Limitations of the present study (use as heading)
• Conclusions (may use as heading)

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Discussion Brief summary of findings

• In the first phrase(s) of the Discussion you may
  stress the main findings
• Use plain language
• Target the busy or non-expert reader
• Emphasize the novelty of your data!
  (if this applies)

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Discussion Brief summary of findings
ENDEAVOR II Circulation 2006
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Boldness, if you can!
Biondi-Zoccai Eur Heart J 2006
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Discussion Current research context

• Continue (from the Introduction) your brief
  review of current research evidence
• This time, take into account your study
• But keep emphasis on other studies

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Discussion Current research context
ENDEAVOR II Circulation 2006
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Discussion What this study adds

• Introduce the clinical and research implications
  of your study
• Do you want to suggest a change in clinical
  practice?
• You can be moderately bold, here

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Discussion What this study adds
ENDEAVOR II Circulation 2006
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Discussion Avenues for further research

• In this section you may spell out what should be
  the target of new research
• This is an important part of the manuscript, if
  you feel only a collaborative effort can achieve
  your goal
• Remember not to disclose too much

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Discussion Avenues for further research
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Discussion - Limitations

• Limitations
• Show yourself as a critical thinker
• Do not overdo it otherwise why did you do the
  stupid study
• Complete the argument (think it through) many
  limitations may be true but they would not
  explain the results
• Better to acknowledge a limitation in advance,
  than having to address it later because the
  referee raised this issue!

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Discussion - Limitations
DELAYED RRISC JACC 2007
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Discussion - Conclusions

• End
• Write a strong conclusion
• Begin with a signal
• In summary In conclusion
• May briefly mention applications, implications,
  speculations
• Use present tense except when making comparisons
  to previous studies or results

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Conclusions

• If the journal has such a section
• State the main findings and/or applications in
  plain language, without being too repetitive
• It must stand alone therefore
• cite no references
• refer to no tables or figures.
• Make no substantial new points of discussion
• Avoid generalizations and "shoulds" that go
  beyond your findings

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Conclusions
ENDEAVOR II Circulation 2006
RRISC JACC 2006
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Questions?
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