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Clinical Writing for Interventional Cardiologists

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Title: Clinical Writing for Interventional Cardiologists


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 - 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

4
Introductory remarks
  • Clinical writing is just like PCI

5
Introductory remarks
  • Clinical writing is just like PCI nobody is
    accomplished at the beginning, but all remarkably
    improve with practice

6
Introductory remarks
  • What are our goals?

7
Introductory remarks
  • What are our goals?
  • to provide you a set of general methods, specific
    tips and tricks, and real-life scenarios
  • to figure out what, when, why, and how to write a
    clinical paper

8
Questions?
9
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

10
What you will learn
  • General principles for clinical writing
  • choice of English
  • reasons for writing clinical papers
  • gestational time for clinical papers
  • hierarchy of clinical literature and evidence
  • practical flowchart for clinical writing

11
Choice of English
12
Choice of English
Why is this presentation in English?
13
Choice of English
Why is this presentation in English? Questa
presentazione è stata preparata in lingua inglese
per permettervi di familiarizzarvi con la
terminologia e gli approcci alla scrittura in
lingua inglese, e anche perché così il relatore
ha potuto risparmiare tempo e parole, ed essere
più chiaro. (single sentence, 39 words) This
presentation was prepared in English to enable
you to familiarize with English terms and
approaches. Moreover, the speaker could thus save
time and words, being also clearer. (two
sentences, 28 words)
14
What you will learn
  • General principles for clinical writing
  • choice of English
  • reasons for writing clinical papers
  • gestational time for clinical papers
  • hierarchy of clinical literature and evidence
  • useful concepts
  • practical flowchart for clinical writing

15
Clinical research writing
Is writing a clinical research paper easy?
16
Remember Grossmans words
I have not foundwriting one bit easier today
than it was 30 years ago. I still have to work
at it very hard and make many revisions, with a
rare exception because the saying of Francis
Bacon has always been deeply impressed in my
mind..Writing maketh an exact man. Morton
Grossman (gt400 scientific papers, 134
editorials, and 71 books or book chapters)
17
Paraphrasing Groucho
The more you write, the better writer you will
become and if I can write in ENGLISH, most
of you can!
18
But life is too short
  • Is the paper worth writing?
  • Have similar findings been reported?
  • Is there a need for another report?
  • Are your findings more convincing?
  • Is the paper important?
  • Apply the so-what test

19
Reasons for writing a paper
A clinician can write a paper for several
reasons -divertissement -build up the
CV -self-advertising -increase collective
knowledge
20
Other reasons
  • No publication, no project
  • Make information available for others
  • No publication, no promotion
  • Yardstick of productivity
  • No publication, no funding
  • What have you done for me lately?

21
Other reasons
I would urge you to write, not because it is a
good thing, not because it is nice to see your
name in print, but rather because you will
really get to know a field only if you contribute
to it Mahoney MJ, Psychology of the Scientist
1979
22
Disclaimer
  • This talk will not help you if you have nothing
    to write about
  • Ability to ask a good question
  • Commitment to career development
  • Willingness to or experience in research
  • Ability to protect your time

23
Who gets the credit?
In science, the credit goes to the man who
convinces the world, not to the man to whom the
idea first occurs. - Sir Francis Darwin
24
Advice keep enjoying writing
Smith et al, BMJ 2003
25
Advice bring the draft wherever it suits you
26
Advice maintain a global view as well as a
27
focused, structured and analytic approach
What landscape should I paint?
Which color for her eyes?
Is she a she or a he?
Am I in love with her?
Who cares about this painting? In a few years
nobody will see it!
28
What you will learn
  • General principles for clinical writing
  • choice of English
  • reasons for writing clinical papers
  • gestational time for clinical papers
  • hierarchy of clinical literature and evidence
  • useful concepts
  • practical flowchart for clinical writing

29
Gestational period for a clinical trial paper
START
PROTOCOL/IRB 2-4 months
STUDIES/ EXPERIMENTS
4-24 months
14-44 Months!
WRITE AND SUBMIT
2-4 months
REWRITE AND RESUBMIT
2-4 months
2-4 months
WAIT
2-4 months
PUBLISHED!
BEST GUESS
30
Time to publication
  • More realistic time from submission to
    publication projections in the WWW era
  • Letters to the Editor 4-12 weeks
  • Editorials 3-6 months
  • Reviews 6-12 months
  • Case reports 6-12 months
  • Non-RCT clinical studies 6-18 months
  • RCTs 6-18 months
  • Ground-breaking RCTs lt6 months

31
Setting goals
  • First author papers in major journals
  • First author papers in secondary journals
  • Total papers
  • Non-first author papers
  • Secondary journals
  • Book chapters or review papers (AVOID ?)

32
Tracking goals
  • Every 3-6 months, tabulate
  • Published papers in past year (Ppub)
  • Number of papers under review (Prev)
  • Number of papers in preparation (Pprep)

33
Probable annual production (PAP)
Ppub Prev Pprep
PAPraw
3
34
Barriers to goals
  • Extrinsic
  • - Major clinical/teaching/research
    responsibilities (R)
  • - Major committee assignments (C)
  • - Personnel disputes (Pers)
  • - Grants (Gr)
  • Intrinsic

35
Adjusted Probable Annual Production (PAPadj)
PAPadj PAPraw 2 (Grn Persn) (R C)
36
Intrinsic causes of writing problems
  • Internal censors
  • Fears of failure
  • Perfectionism
  • Procrastination

37
Censors
  • Watchers at the Gate
  • - Internal censors
  • - Internal critics
  • Induce bad feelings about writing
  • Undermine ability to generate ideas

38
Censors
When you hear him, the internal critic speaks in
a shrill tone, rational, often pessimistic,
alerts only to the dangers of the world around
us, and therefore to the shortcomings in our work.
Assuming the voices of parents, teachers, and
other authority figures, he whispers and
sometimes shouts that our writing is bad He
edits words and thoughts before we have a chance
to put them on paper, and thus creates a blank
page panic.
39
Intrinsic blocks to writing
  • Inability to start writing
  • - First, there is the difficulty of writing at
    all
  • D. Brande Becoming a Writer
  • - Perfectionism, self-consciousness,
    procrastination

40
How to increase and sustain productivity
  • Time management
  • Stimulus control
  • Contingency management
  • Limit and deadline setting

41
How to increase and sustain productivity
  • Work
  • Daily
  • 30 minutes to one hour
  • Do not pay attention to structure, grammar,
    spelling
  • Jump from project to project

42
Spontaneous writing
  • You cant think and hit at the same time Y.
    Berra
  • Learn to write
  • Without feeling ready
  • Without feeling fully in control
  • Without awaiting inspiration
  • Learning to write at a gallop leaves ones
    internal critics behind V. Woolf
  • Once under way, writing builds its own momentum

43
Best time to write
  • Morning
  • Afternoon
  • Evening
  • Night
  • Pick a time and protect it!!!

44
Inability to finish writing
  • Multiple revisions
  • Multiple analyses
  • Each time I think I am finished,
    I see there is a lot more to do
  • Similar roots as inability to start
    (perfectionism)
  • Different people
  • Lack of insight

45
What you will learn
  • General principles for clinical writing
  • choice of English
  • reasons for writing clinical papers
  • gestational time for clinical papers
  • hierarchy of clinical literature and evidence
  • useful concepts
  • practical flowchart for clinical writing

46
Which manuscript?
47
Which manuscript?
Before beginning writing, you need
to choose the manuscript type/design
48
Choosing a manuscript type
Manuscript type Abstract for
scientific meeting Letter to the
Editor Editorial Book chapter Qualit
ative review Systematic review Case
reports or Images Case series Non-RCT
study RCT
49
Choosing a manuscript type
Manuscript type Effort Abstract for
scientific meeting Letter to the
Editor Editorial Book
chapter Qualitative review
Systematic review Case reports or
Images Case series Non-RCT
study RCT
50
Choosing a manuscript type
Manuscript type Effort Reward Abstrac
t for scientific meeting Letter to
the Editor Editorial
Book chapter Qualitative
review Systematic review
Case reports or Images Case
series Non-RCT study
RCT
51
Choosing a manuscript type
Manuscript type Effort Reward Abstrac
t for scientific meeting Letter to
the Editor Editorial
Book chapter Qualitative
review Systematic review
Case reports or Images Case
series Non-RCT study
RCT
52
Levels of articles
Primary Peer Reviewed Secondary Not peer
reviewed
Primary
Secondary
53
Levels of peer-reviewed articles
Primary original research Secondary review
articles Tertiary textbooks, summaries
Primary
Secondary
Tertiary
54
Parallel hierarchy of CV research
Qualitative reviews
Case reports and series
Observational studies
Systematic reviews
Observational controlled studies
Meta-analyses from individual studies
Randomized controlled trials
Meta-analyses from individual
patient data
Multicenter randomized controlled trials
Biondi-Zoccai et al, Ital Heart J 2003
55
What about evidence-based medicine?
Excerpt from a 1990 leaflet for internal medicine
resident at McMaster University (Hamilton,
Canada) goal of evidence-based medicine is to
be aware of the evidence on which ones practice
is based, the soundness of the evidence, and the
strength of inference the evidence permits. The
strategy employed requires a clear delineation of
the relevant question(s) a thorough search of
the literature relating to questions a critical
appraisal of the evidence, and its applicability
to the clinical situation and a balanced
application of the conclusions to the clinical
problem.
Guyatt and Rennie, Users guide to the medical
literature, 2002
56
Evidence-based medicine (EBM)
Definition The coscientious, explicit, and
judicious use of current best evidence in making
decisions about the care of individual
patients. The practice of evidence-based medicine
requires integration of individual clinical
expertise and patient preferences with the best
available external clinical evidence from
systematic search.
Guyatt and Rennie, Users guide to the medical
literature, 2002
57
Rebuttal to critics of EBM
Evidence alone is never sufficient to make a
clinical decision decision makers must always
trade the benefits and risks, inconvenience, and
costs associated with alternative management
strategies, and in doing so consider the
patients values!
Guyatt and Rennie, Users guide to the medical
literature, 2002
58
EBM hierarchy of evidence
  1. N of 1 randomized controlled trial
  2. Systematic reviews of randomized trials
  3. Single randomized trial
  4. Systematic review of observational studies
    addressing patient-important outcomes
  5. Single observational study addressing
    patient-important outcomes
  6. Physiologic studies (eg blood pressure, cardiac
    output, exercise capacity, bone density, and so
    forth)
  7. Unsystematic clinical observations

Guyatt and Rennie, Users guide to the medical
literature, 2002
59
Basic science study
Kwon et al, J Clin Invest 1998
60
Preclinical study
Joner et al, JACC 2008
61
Image in medicine
Sheiban et al, J Cardiovasc Med 2007
62
Case report(s)
McFadden et al, Lancet 2004
63
Cross-sectional study
Herrington et al, Circulation 2004
64
Case-control study
Fujii et al, JACC 2005
65
Cohort study (registry)
Lee et al, EuroInterv 2007
66
Cohort study (registry)
Lee et al, EuroInterv 2007
67
Non-randomized controlled study
Ong et al, JACC 2005
68
Cross-over study
Bansch et al, Circulation 2004
69
A pivotal randomized trial
Fajadet et al, Circulation 2006
70
A pragmatic randomized trial
Galloe et al, JAMA 2008
71
Editorial
Camenzind, NEJM 2006
72
Qualitative review
Romagnoli et al, JACC Int 2008
73
Qualitative review
Melikian et al, Heart 2008
74
Systematic review (without meta-analysis)
Kip et al, JACC 2008
75
Study level meta-analysis
Agostoni et al, JACC 2004
76
Individual patient level meta-analysis
ATC, BMJ 2002
77
Another individual patient level meta-analysis
Kastrati et al, NEJM 2007
78
Your choice of type/design
The optimal type/design depends on your skills,
findings, message and audience But
remember your ultimate goal
79
Ultimate goal of research appraisal of causation
80
What you will learn
  • General principles for clinical writing
  • choice of English
  • reasons for writing clinical papers
  • gestational time for clinical papers
  • hierarchy of clinical literature and evidence
  • useful concepts
  • practical flowchart for clinical writing

81
Some other pivotal (and useful) concepts
  • Precision and accuracy
  • Random and systematic (ie bias) errors
  • Internal and external (ie generalizability)
    validity
  • Type I (alpha) and type II (beta) errors
  • Sample size and statistical power

82
Accuracy and precision
true value
measurement
distance
spread
Accuracy measures the distance from the true value
Precision measures the spead in the measurements
83
Accuracy and precision
84
Accuracy and precision
example
Schultz et al, Am Heart J 2004
85
Accuracy and precision
example
Schultz et al, Am Heart J 2004
86
Random and systematic errors
Thus Precision expresses the extent of RANDOM
ERROR Accuracy expresses the extent
of SYSTEMATIC ERROR (ie bias)
87
Bias
Bias is a systematic DEVIATION from the TRUTH -
in itself it cannot be ever recognized - there
is a need for external gold standard and/or
permanent surveillance
88
An incomplete list of bias
Selection bias Information bias
Confounders Observation bias
Investigators bias (enthusiasm bias)
Patients background bias Distribution
of pathological changes bias Selection
bias Small sample size bias
Reporting bias Referral bias
Variation bias Recall bias
Statistical bias Selection bias
Confounding Intervention bias
Measurement or information Interpretation
bias Publication bias Subject
selection/sampling bias
Simplest classification 1. Selection bias
2. Information bias
Sackett, J Chronic Dis 1979
89
Validity
Internal validity entails both PRECISION and
ACCURACY (ie does a study provide a truthful
answer to the research question?) External
validity expresses the extent to which the
results can be applied to other contexts and
settings. It corresponds to the distinction
between SAMPLE and POPULATION)
90
Validity
Rothwell, Lancet 2005
91
Alpha and type I error
Whenever I perform a test, there is thus a risk
of a FALSE POSITIVE result, ie REJECTING A TRUE
null hypothesis This error is called type I, is
measured as alpha and its unit is the p
value The lower the p value, the lower the risk
of falling into a type I error (ie the HIGHER the
SPECIFICITY of the test)
92
Alpha and type I error
Type I error is like a MIRAGE
Because I see something that does NOT exist
93
Beta and type II error
Whenever I perform a test, there is also a risk
of a FALSE NEGATIVE result, ie NOT REJECTING A
FALSE null hypothesis This error is called type
II, is measured as beta, and its unit is a
probability The complementary of beta is called
power The lower the beta, the lower the risk of
missing a true difference (ie the HIGHER the
SENSITIVITY of the test)
94
Beta and type II error
Type II error is like being BLIND
Because I do NOT see something that exists
95
Summary of errors
Experimental study Experimental study
H0 accepted H0 rejected
Truth H0 true ? Type I error
Truth H0 false Type II error ?
96
Power and sample size
Whenever designing a study or analyzing a
dataset, it is important to estimate the sample
size or the power of the comparison SAMPLE
SIZE Setting a specific alpha and a specific
beta, you calculate the necessary sample size
given the average inter-group difference and its
variation POWER Given a specific sample size and
alpha, in light of the calculated average
inter-group difference and its variation, you
obtain an estimate of the power (ie 1-beta)
97
What you will learn
  • General principles for clinical writing
  • choice of English
  • reasons for writing clinical papers
  • gestational time for clinical papers
  • hierarchy of clinical literature and evidence
  • useful concepts
  • practical flowchart for clinical writing

98
Flowchart for paper drafting
99
Flowchart for paper drafting
  1. Title
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Discussion

100
Flowchart for paper drafting
  1. Title
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Discussion

Choose your title at the very beginning, even
before starting collecting data!
101
Flowchart for paper drafting
  1. Title
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Discussion

Begin drafting your abstract as soon as possible,
leaving where detailed results will come
after data collection
102
Flowchart for paper drafting
  1. Title
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Discussion

Write and close the Introduction even before
beginning data collection. This will save you
time and you will not have to go back to this
tedious section any longer
103
Flowchart for paper drafting
  1. Title
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Discussion

Methods should, obviously, be completed as soon
as possible, as only those procedures that you
have thought out will be followed during the
study conduct
104
Flowchart for paper drafting
  1. Title
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Discussion

Results can also be preliminarily drafted before
study completion, leaving where detailed data
will come out
105
Flowchart for paper drafting
  1. Title
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Discussion

The Conclusion is the main message of your work.
Figure out ASAP your true bottom line, and then
work on the rest of the paper accordingly
106
Flowchart for paper drafting
  1. Title
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Discussion

The Discussion will follow easily. I usually
spend no more than a couple of days of work on it
(leaving a few traps for reviewers)
107
Flowchart for paper drafting
Quite often, results modify your overall view of
the topic and lead you to revisions of the whole
paper
  1. Title
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Discussion

108
Questions?
109
Take home messages
110
Take home messages
  1. Know your subject well
  2. Know who your readers are and what they want
  3. Know how to use the tools of written expression
  4. Read a lot
  5. Follow the journals rules

111
Take home messages
6. Schedule time for writing 7. Wear one hat at a
time a. Student b. Clinician c. Planner d.
Creator e. Proofreader f. Editor
112
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