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 algorithm Introduction Background Limitations of current evidence Study hypothesis Methods Design Patients Procedures Follow-up End-points Additional analyses Statistical analysis Results Baseline and procedural data Early outcomes Mid-to-long term outcomes Additional analyses Discussion Summary of study findings Current research context Implications of the present study Avenues for further research Limitations of the present study Conclusions

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

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!

RRISC JACC 2006 Patient and procedural data

RRISC JACC 2006 Patient and procedural data

RRISC JACC 2006 Patient and procedural data

RRISC JACC 2006 Patient and procedural data

RRISC JACC 2006 Patient and procedural data

RRISC JACC 2006

Ancillary findings In this case late loss (QCA based) was the primary endpoint, thus priority to it (non clinical – ancillary endpoint)

RRISC JACC 2006 Ancillary findings

RRISC JACC 2006 Primary Endpoint

Ancillary findings

RRISC JACC 2006 Early outcomes

RRISC JACC 2006

Late outcomes RRISC JACC 2006

Late outcomes RRISC JACC 2006

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 algorithm Introduction Background Limitations of current evidence Study hypothesis Methods Design Patients Procedures Follow-up End-points Additional analyses Statistical analysis Results Baseline and procedural data Early outcomes Mid-to-long term outcomes Additional analyses Discussion Summary of study findings Current research context Implications of the present study Avenues for further research Limitations of the present study Conclusions

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 al 17 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

Why using a structured format for the Discussion: 1. 1.Helps organizing your writing 2. 2.Enhances readability 3. 3.Shows off that you follow a structured approach in everything you do

Structuring the Discussion The usual structure of the Discussion is: 1. 1.Brief summary of the study findings (no need for heading) 2. 2.Current research context (use as heading) 3. 3.Implications of the present study (use as heading) 4. 4.Avenues for further research (use as heading) 5. 5.Limitations of the present study (use as heading) 6. 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 ENDEAVOR II Circulation 2006

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 ENDEAVOR II Circulation 2006

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 RRISC JACC 2006

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!

DELAYED RRISC JACC 2007 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?

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