1. Clinical Writing for Interventional Cardiologists

2. What you will learn - hopefully!
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 Specific techniques
focus on journal and readership
IMRAD approach
guidelines for specific study designs (eg CONSORT, QUOROM, MOOSE)
other tips & tricks

4. What you will learn Specific techniques
focus on journal and readership
IMRAD approach
guidelines for specific study designs (eg CONSORT, QUOROM, MOOSE)
other tips & tricks

5. First tip to effective writing

6. First tip to effective writing
Read a lot…

7. First tip to effective writing
Read a lot…
To learn something, you must see how it should be done, and how it should NOT be done!

8. Second tip to effective writing

9. What is the message you want to sell?
Second tip to effective writing
What is the message you want to sell?

10. What is the message you want to sell?
Second tip to effective writing
What is the message you want to sell?
It may be the core message, or the corollary/cosmetic message of your paper

11. Third tip to effective writing

12. Third tip to effective writing
Who is the audience?

13. Third tip to effective writing
Who is the audience?
You have to adjust your message, tailor your style, and prepare yourself for potential criticisms based on the target audience…

14. Fourth tip to effective writing

15. No matter what, keep clear writing!
Fourth tip to effective writing
No matter what, keep clear writing!

16. No matter what, keep clear writing!
Fourth tip to effective writing
No matter what, keep clear writing!
“Clear writing that is incapable of being misunderstood”
Quintilian, I A.D.

17. Fifth tip to effective writing

18. Do not mistake the tree for the forest!!!
Fifth tip to effective writing
Do not mistake the tree for the forest!!!

19. Do not mistake the tree for the forest!!!
Fifth tip to effective writing
Do not mistake the tree for the forest!!!
The goal is the forest, of course

20. What you will learn Specific techniques
focus on journal and readership
IMRAD approach
guidelines for specific study designs (eg CONSORT, QUOROM, MOOSE)
other tips & tricks

21. IMRAD algorithm
Introduction (± Aim)
Methods
Results
And
Discussion

22. IMRAD algorithm
Introduction (± Aim)
Methods
Results
And
Discussion

23. IMRAD algorithm
Introduction (± Aim)
Methods
Results
And
Discussion

24. IMRAD algorithm
Introduction (± Aim)
Methods
Results
And
Discussion

25. IMRAD algorithm
Introduction (± Aim)
Methods
Results
And
Discussion

26. 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
Discussion Summary of study findings
Current research context
Implications of the present study
Avenues for further research
Limitations of the present study
Conclusions

27. 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
Discussion Summary of study findings
Current research context
Implications of the present study
Avenues for further research
Limitations of the present study
Conclusions

28. 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
Discussion Summary of study findings
Current research context
Implications of the present study
Avenues for further research
Limitations of the present study
Conclusions

29. 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
Discussion Summary of study findings
Current research context
Implications of the present study
Avenues for further research
Limitations of the present study
Conclusions

30. What you will learn Specific techniques
focus on journal and readership
IMRAD approach
guidelines for specific study designs (eg CONSORT, QUOROM, MOOSE)
other tips & tricks

31. CONSORT guidelines for RCT
Moher et al, JAMA 2001

32. CONSORT statement
Moher et al, JAMA 2001

33. CONSORT statement
Moher et al, JAMA 2001

34. STARD guidelines for diagnostic studies
Bossuyt et al, Lancet 2003

35. STARD guidelines
Bossuyt et al, Lancet 2003

36. STARD guidelines
Bossuyt et al, Lancet 2003

37. QUADAS guidelines to assess diagnostic studies
Whiting et al, BMCMRM 2003

38. QUADAS guidelines
Whiting et al, BMCMRM 2003

39. QUOROM statement for RCT meta-analyses
Moher et al, Lancet 1999

40. MOOSE guidelines for non-RCT meta-analyses
Stroup et al, JAMA 2000

41. MOOSE guidelines
Stroup et al, JAMA 2000

42. MOOSE guidelines
Stroup et al, JAMA 2000

43. What you will learn Specific techniques
focus on journal and readership
IMRAD approach
guidelines for specific study designs (eg CONSORT, QUOROM, MOOSE)
other tips & tricks

44. Never throw away a good sentence, but never keep a bad one!
“There is no good writing… only good re-writing”
Rationale: We are better at editing than writing
Methods of conserving sentences:
Write about the same thing
Use similar methods
Dictation

45. General tips Include one thought per sentence, one idea per paragraph
Use active voice whenever possible
Keep words simple
Be as succinct as possible
Avoid adjectives, too much description
Keep sentences short (< 22 words) and clear
Use subject-verb-object constructions:
Of the 22 patients, 5 (22.7%) developed restenosis

46. General tips Use transitions and key words Outline
Consult a statistician
Install spell-check software
Consult grammar and writing websites
Buy the AMA Manual of Style
Hire an editor
Remember the question

47. Other tips
Use “men” and “women,” not “males” and “females” (except when male and female are used as adjectives, e.g., male patients)
Use “died,” not “expired”
Use “humanely killed” or “killed” for animal studies, not “sacrificed”
Replace “prior to” with “before”
Patients are not implanted, i.e., “Patients who had the Jarvik 2000 implanted,” not “The implanted patients…”
Be careful of “due to” and “because of.” Use “due to” only when you could substitute “caused by”
Recovery of brisk flow was due to thrombectomy
Because of thrombectomy, recovery of brisk flow occurred

48. Tips for better writing: words
Simple words are better than long ones
Concrete terms are better than abstract ones
Specific terms are better than general ones

49. Tips for better writing: grammar
Avoid wordiness
Know when to use active & passive voice
Avoid faulty parallelism
Paragraphs should hang together
Paragraphs should have transitions

50. Phrases
“The device, with long-term durability and reliability, is enhanced by the simplicity of its design and the clinical quality of its implantable platform. The ease of stent implantation in all patients, that enables avoidance of recoil, with the superior elastic properties and the extreme biocompatibility, are unique to this technology.”

51. Phrases
“The device, with long-term durability and reliability, is enhanced by the simplicity of its design and the clinical quality of its implantable platform. The ease of stent implantation in all patients, that enables avoidance of recoil, with the superior elastic properties and the extreme biocompatibility, are unique to this technology.”
NO!

52. Phrases
“The device, with long-term durability and reliability, is enhanced by the simplicity of its design and the clinical quality of its implantable platform. The ease of stent implantation in all patients, that enables avoidance of recoil, with the superior elastic properties and the extreme biocompatibility, are unique to this technology.”
“The simplicity of its design and the clinical quality of its implantable platform enhance the durability and reliability of the device. The stent is easy to implant in all patients. Moreover, it effectively prevents recoil, has superior elastic properties and is extremely biocompatible. All these characteristics make this novel stent unique among the others”
NO!

53. Format Double space Each section on a separate page
Use subheadings (in Methods, Results)
Page numbers on the right (bottom..or top)
Make sure font size and type consistent
Format the documents with margins of 2.0 to 3.0 mm from top, bottom, & sides

54. Tense in scientific English
Present tense – for previously published information accepted as fact:
Spatial resolution of MR microscopy can reach 3 microns [ref]
Present tense – refers to other parts of your document:
Figure 4 shows a diffusion-weighted image
Past tense – for methods and results/actions:
Rats were anesthetized with isoflurane
All animals exhibited significantly diminished learning capacity...
Past perfect – for action(s) that happened before other past action(s):
Group 2 rats had been housed individually prior to the beginning of the study
Present perfect – for action(s) recently completed or continuing to now:
Since 1991, researchers at the Montefiore Medical Center have collaborated with more than thirty investigators at other institutions

55. Editing Does it make sense? Is the writing clear?
Are there obvious factual errors?
Check for vague or ambiguous statements
Check for wordiness
Check for errors in grammar, spelling, punctuation, capitalization, and follow the journal’s rules

56. Let’s think backwards…
What is your goal in preparing an article
Let’s think backwards…

57. relevant aspects of your study, ie:
What is your goal in preparing an article
The main goals in preparing a manuscript are full reporting and disclosure of
relevant aspects of your study, ie:
Is there any risk of bias?
What are the findings?
Do your findings apply to the my current clinical problem?

58. Internal validity appraisal according to The Cochrane Collaboration
4 MAIN TYPES OF BIAS POTENTIALLY UNDERMINING STUDIES
Ascertainment bias
Non-uniform adjudication of events
Attrition bias
Non-uniform follow-up or compliance to treatment
Performance bias
Non-uniform performance of corollary treatments
Selection bias
The non-random allocation of pts one of the treatment groups

59. How your article should be appraised, in three steps:
The EBM 3-step approach
How your article should be appraised, in three steps:
Step 1 – Are the results of the study (internally) valid?
Step 2 – What are the results?
Step 3 – How can I apply these results to patient care?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

60. Articles about therapy
Are the results valid?
Did experimental and control groups begin the study with a similar prognosis?
Were pts randomized?
Was randomization concealed?
Were pts analyzed in the groups to which they were randomized?
Were pts in the treatment and control groups similar with respect to known prognostic factors?
Did experimental and control groups retain a similar prognosis after the study started?
Were pts aware of group allocation?
Were clinicians aware of group allocation?
Were outcome assessors aware of group allocation?
Was follow-up complete?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

61. Articles about therapy
What are the results?
How large was the treatment effect?
How precise was the estimate of the treatment effect?
How can I apply the results to patient care?
Were the study patients similar to my patient?
Were all clinically important outcomes considered?
Are the likely treatment benefits worth the potential harm and costs?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

62. Guyatt and Rennie, Users’ guide to the medical literature, 2002
Articles about harm
Are the results valid?
Did experimental and control groups begin the study with a similar prognosis?
Did the investigators demonstrate similarity in all known determinants of outcome; did they adjust for differences in the analysis?
Were exposed patients equally likely to be identified in the two groups?
Did experimental and control groups retain a similar prognosis after the study started?
Were the outcomes measured in the same way in the groups being compared?
Was follow-up sufficiently complete?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

63. Articles about diagnostic testing
Are the results valid?
Did clinicians face diagnostic uncertainty?
Was there a blind comparison between the test and an independent gold standard?
Did the results being evaluated influence the decision to perform the gold standard?
What are the results?
What likelihood ratios were associated with the range of possible test results?
How can I apply the results to patient care?
Will the reproducibility of the test result and its interpretation be satisfactory in my clinical setting?
Are the results applicable to the pts in my practice?
Will the results change my management strategy?
Will pts be better off as a result of the test?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

64. Articles about prognosis
Are the results valid?
Was the sample of patients representative?
Were the pts sufficiently homogeneous with respect to prognostic risk?
Was follow-up sufficiently complete?
Were objective and unbiased outcome criteria used?
What are the results?
How likely are the outcomes over time?
How precise are the estimates of likelihood?
How can I apply the results to patient care?
Were the study pts and their management similar to those in my clinical practice?
Was the follow-up sufficiently long?
Can I use the results in managing pts of my practice?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

65. Guyatt and Rennie, Users’ guide to the medical literature, 2002
Review articles
Are the results valid?
Did the review explicitly address a sensible clinical question?
Was the search for relevant studies detailed and exhaustive?
Were the primary studies of high methodological quality?
Were assessments of studies reproducible?
What are the results?
Were the results similar from study to study?
What are the overall results of the review?
How precise were the results?
How can I apply the results to patient care?
How can I best interpret the results to apply them to the care of patients in my practice?
Were all clinically relevant outcomes considered?
Are the benefits worth the costs and potential risks?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

66. Treatment guidelines and decision analyses
Did the recommendations consider all relevant patient groups, management options, and possible outcomes?
Is there a systematic review of evidence linking options for each relevant question?
Is there an appropriate specification of values or preferences associated with outcomes?
Do the authors indicate the strength of their recommendations?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

67. Articles about economic analyses
Are the results valid?
Did the recommendations consider all relevant patient groups, management options, and possible outcomes?
Did investigators adopt a sufficiently broad viewpoint?
Are results reported separately for pts whose baseline risk differs?
Is there a systematic review and summary of evidence linking options to outcomes for each relevant question?
Were costs measured accurately?
Did investigators consider the timing of costs and consequences?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

68. Articles about economic analyses
What are the results?
What were the incremental costs and effects of each strategy?
Do incremental costs and effects differ between subgroups?
How much does allowance for uncertainty change the results?
How can I apply the results to patient care?
Are the treatment benefits worth the risks and costs?
Can I expect similar costs in my setting?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

69. Guyatt and Rennie, Users’ guide to the medical literature, 2002
Articles about harm
What are the results?
How strong is the association between exposure and outcome?
How precise is the estimate of the risk?
How can I apply the results to patient care?
Were the study patients similar to the patient under consideration in my practice?
Was the duration of follow-up adequate?
What was the magnitude of risk?
Should I attempt to stop the exposure?
Guyatt and Rennie, Users’ guide to the medical literature, 2002

70. Questions?

71. For further slides on these topics please feel free to visit the metcardio.org website: