Clinical Writing for Interventional Cardiologists

Clinical Writing for Interventional Cardiologists

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

What you will learn

• Writing the Results– goals of Results– effective tips

What were the findings?

The answer is in the Results.

Results

Expanded IMRAD algorithmIntroduction Background

Limitations of current evidenceStudy hypothesis

Methods DesignPatientsProceduresFollow-upEnd-pointsAdditional analysesStatistical analysis

Results Baseline and procedural dataEarly outcomesMid-to-long term outcomesAdditional analyses

Discussion Summary of study findingsCurrent research contextImplications of the present studyAvenues for further researchLimitations of the present studyConclusions

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

Results

Show subject characteristics as n/N (%) and

means± SD (or median [interquartile range])

In an intervention:

• show pre-test means±SD as subject characteristics

• show change-score means±SD 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

Results

• Results should be simply stated (past tense)

• (Almost) never show test statistics (t, F, χ2)

• 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 94±3 vs 85±5 mm Hg, P=0.035).

Results

• Results should be simply stated (past tense)

• (Almost) never show test statistics (t, F, χ2)

• 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 94±3 vs 85±5 mm Hg, P=0.035).

The resting blood pressure was94±3 mm Hg in the 30

tennis players vs 85±5 in the 20 controls (P=0.035).

Results

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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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

Ancillary findings

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PrimaryEndpoint

Ancillary findings

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Early outcomes

Early outcomes

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Late outcomes

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Late outcomes

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Questions?

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

What you will learn

• Writing the Discussion– goals of Discussion– effective tips

What do these findings mean?

The answer is in the Discussion.

Discussion

Expanded IMRAD algorithmIntroduction Background

Limitations of current evidenceStudy hypothesis

Methods DesignPatientsProceduresFollow-upEnd-pointsAdditional analysesStatistical analysis

Results Baseline and procedural dataEarly outcomesMid-to-long term outcomesAdditional analyses

Discussion Summary of study findingsCurrent research contextImplications of the present studyAvenues for further researchLimitations of the present studyConclusions

Discussion vs Results

Remember:

Results and Discussion sections

should appear as written by

two different people!

• 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

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

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…

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.“

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)

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.”

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.”

• Other’s 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 …”

Discussion

Discussion

Why using a structured format for the

Discussion:

1.Helps organizing your writing

2.Enhances readability

3.Shows off that you follow a structured

approach in everything you do

Structuring the Discussion

The usual structure of the Discussion is:

1. Brief summary of the study findings (no need for

heading)

2. Current research context (use as heading)

3. Implications of the present study (use as heading)

4. Avenues for further research (use as heading)

5. Limitations of the present study (use as heading)

6. Conclusions (may use as heading)

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)

ENDEAVOR II Circulation 2006

Discussion – Brief summary of findings

Boldness, if you can!

Biondi-Zoccai Eur Heart J 2006

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

Discussion – Current research context


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

Discussion – What this study adds


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

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

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

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

Conclusions

RRISC JACC 2006 ENDEAVOR II Circulation 2006

Questions?

For further slides on these topics please feel free to visit the

metcardio.org website:

http://www.metcardio.org/slides.html

Documents

Clinical Writing for Interventional Cardiologists