Clinical Writing for Interventional Cardiologists

1. Clinical Writing for Interventional Cardiologists

2. 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

3. What you will learn • Writing the Results • goals of Results • effective tips

4. Results What were the findings? The answer is in the Results.

5. Expanded IMRAD algorithm IntroductionBackground Limitations of current evidence Study hypothesis MethodsDesign Patients Procedures Follow-up End-points Additional analyses Statistical analysis Results Baseline and procedural data Early outcomes Mid-to-long term outcomes Additional analyses DiscussionSummary of study findings Current research context Implications of the present study Avenues for further research Limitations of the present study Conclusions

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

7. 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

8. 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).

9. 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).

10. Results • Summarize multiple outcomes in a figure or table • Avoidrepetition 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!

11. Patient and procedural data RRISC JACC 2006

12. Patient and procedural data RRISC JACC 2006

13. Patient and procedural data RRISC JACC 2006

14. Patient and procedural data RRISC JACC 2006

15. Patient and procedural data RRISC JACC 2006

16. Patient and procedural data RRISC JACC 2006

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

18. Ancillary findings RRISC JACC 2006

19. Ancillary findings RRISC JACC 2006 Primary Endpoint

20. Ancillary findings

21. Early outcomes RRISC JACC 2006

22. Early outcomes RRISC JACC 2006

23. Late outcomes RRISC JACC 2006

24. Late outcomes RRISC JACC 2006

25. Questions?

26. 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

27. What you will learn • Writing the Discussion • goals of Discussion • effective tips

28. Discussion What do these findings mean? The answer is in the Discussion.

29. Expanded IMRAD algorithm IntroductionBackground Limitations of current evidence Study hypothesis MethodsDesign Patients Procedures Follow-up End-points Additional analyses Statistical analysis Results Baseline and procedural data Early outcomes Mid-to-long term outcomes Additional analyses DiscussionSummary of study findings Current research context Implications of the present study Avenues for further research Limitations of the present study Conclusions

30. Discussion vs Results Remember: Results and Discussion sections should appear as written by two different people!

31. 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

32. 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

33. 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…

34. 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.“

35. 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)

36. 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.”

37. 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 …”

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

39. 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)

40. 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)

41. Discussion – Brief summary of findings ENDEAVOR II Circulation 2006

42. Boldness, if you can! Biondi-Zoccai Eur Heart J 2006

43. 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

44. Discussion – Current research context ENDEAVOR II Circulation 2006

45. 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

46. Discussion – What this study adds ENDEAVOR II Circulation 2006

47. 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

48. Discussion – Avenues for further research RRISC JACC 2006

49. 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!

50. Discussion - Limitations DELAYED RRISC JACC 2007