Clinical Writing for Interventional Cardiologists

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

What you will learn• Bibliographic search and writing the Introduction

– methods of bibliographic search– most popular databases, including Google Scholar,

PubMed, Web of Science– goals of Introduction– effective tips for Introduction

What to choose for a bibliographic search?

Simple and easy-going

or …

fast but tough?

Seniors, juniors, and colleagues

Textbooks

Medical journals

World wide web

1st step: framing the question

• Population: who are the relevant patients?

• Intervention or exposure: what are the management

strategies we want to appraise or the relevant harmful exposure

we want to study?

• Outcome: what are the patient-relevant consequences of

the exposure in which we are interested?

1st step: framing the question

2nd step: determining question type

• Therapy: determining the effect of different treatments on improving

patient function and avoiding adverse events

• Harm: ascertaining the effects of potentially harmful agents on patient

function, morbidity, and mortality

• Diagnosis: establishing the power of an intervention to differentiate

between those with and those without a target condition or disease

• Prognosis: estimating the future course of a patient’s disease

2nd step: determining question type

1st step: example

• All-purpose question: are 1st generation DES safe?

• Improved (searchable) question:

Population: patients with acute or chronic coronary disease

undergoing PCI

Intervention/Comparison: implantation of 1st generation DES

(Intervention) vs BMS (Comparison) – randomized allocation

Outcome(s): death, myocardial infarction, stroke, repeat

revascularization, stent thrombosis, rehospitalizations, costs

2nd step: example

• Therapy: which embolic protection device is more effective

and safe?

• Harm: what is the risk of stent fracture with DES?

• Diagnosis: can I recognize which angiographically-

intermediate coronary lesions are functionally significant?

• Prognosis: can I predict which patients are more likely to

develop stent thrombosis if treated with DES?

WWW resources• BioMedCentral: www.biomedcentral.com

• Clinical Trial Results: www.clinicaltrialresults.org/

• Clinicaltrials.gov: www.clinicaltrials.gov

• DARE: www.york.ac.uk/inst/crd/crddatabases.htm

• EMBASE: www.embase.com

• Google Scholar: scholar.google.com

• Medscape: www.medscape.com

• meta Register of Controlled Trials (mRCT): www.controlled-trials.com/mrct/

• PubMed: www.pubmed.gov

• The Cochrane Library: www.cochrane.org

• UpToDate: www.uptodate.com

• WebMD: www.webmed.com

• Web of Science: isiknowledge.com

BioMedCentral

• BioMedCentral is provided by a private UK

company (the same that provides mRCT)

• It mostly contains open access journals or

conference proceedings

• It may be a useful and cheap (it’s free!) starting

point, but to date its content is limited

• In the future however it should vastly expand

BioMedCentral

Clinical Trial Results

• CTR is provided for free by C.M. Gibson

(the author of the TIMI frame count

and TIMI myocardial perfusion grade)

• It contains pre-publication data from recent

clinical trials

• However, it is not comprehensive and its scope

largely reflects the interests of its developer (ie

coronary disease)

Clinical Trial Results

clinicaltrials.gov

• clinicaltrials.gov is the FDA-supported and

recommended registry of prospective studies

• It contains protocols of ongoing or recently

completed trials

• Registration in clinicaltrials.gov or similar

registries is now mandatory to be eligible for

publication of prospective studies in major

journals

clinicaltrials.gov

• The Database of Abstracts of Reviews of

Effectiveness is provided for free by the University

of York

• It contains titles and abstracts of systematic reviews

of effectiveness

• Each item contained (ie systematic reviews) is a

very good starting point to get info on a topic

• However, some hits are obsolete and no papers on

prognosis, diagnosis, or pathophysiology are

included to date

DARE

EMBASE

• EMBASE is a comprehensive archiving site,

provided for a fee by Elsevier

• Its scope is similar but greater and largely non-

overlapping with MEDLINE/PubMed

• It may be useful for sophisticated researchers and

systematic reviewers

• However, it’s expensive and rarely needed, as most

important papers will be already in MEDLINE/

PubMed

EMBASE

Google Scholar

Google Scholar • Scholar Google is provided for free by Google

• It contains citations and direct links to abstracts or full text

articles

• In addition, it enables citation analysis, thus forward and

backward snowballing

• It’s not yet very structered, and highly relevant citations

might not be included or missed because buried among

thousands of non-relevant ones

MEDSCAPE

• A freely surfable website providing disparate

content, now owned by the WebMD company

• The Cardiology section is often updated and may

provide recent data on trials or other news

• It is not developed or maintained systematically,

and thus lacks comprehensiveness

MEDSCAPE

• The meta Register of Controlled Trials is a freely

searchable website containing data on registered

trials

• It is provided by the owner of BioMedCentral

• It’s a good source on recent or ongoing (thus

unpublished) trials

• While interesting for the clinical researcher or

meta-analyst, it’s scope is limited to RCT

mRCT

PubMed

• PubMed is the web (and free) version of MEDLINE

(provided by the US National Library of Medicine)

• It contains data on articles printed every day in several

thousands medical journals around the world, even if there

is some bias toward US and English-language publications

• It is reasonably comprehensive and sophisticated,

especially for the expert user

• Nonetheless, many papers can still be missed by the

MEDLINE indexers, and using PubMed requires some

expertise

PubMed

PubMed: tips and tricksThere are 4 basic ways to search PubMed:

• Free text searches• Searches with descriptors (Medical Subject Headings,

MeSH) • Clinical queries (specific filters for studies or topics)• Limits (enable the searcher to select several

characteristics, such as language, article type, study type, and so forth)

• History

The ideal search combines one or more of such instruments to obtain precise and concise answers to the clinical question

Free text searches

Limits

Clinical queries

History

Where to learn how to use PubMed?

The Cochrane Collaboration

• The Cochrane Collaboration provides abstracts of

systematic reviews for free and full texts and additional

services for a fee

• It contains the most rigorous systematic reviews available

to date on treatment

• No comprehensive systematic reviews are yet available for

other topics

• Many reviews, while highly valid and pertinent, might be

outdated because of infrequent updates

The Cochrane Collaboration

UpToDate

• UpToDate is provided for a fee by an American company

• It provides qualitative reviews of most topics, with the

specific features that reviews are updated very frequently

• No strict methodology for review production or update is

enforced

• In addition, it might seem superficial and not detailed

enough for experts of a topic

UpToDate

• WebMD is a comprehensive website for healthcare

professional, that can be accessed upon fee

subscription

• It is relatively comprehensive but unstructured

• Resembles (albeit with less cardiovascular focus)

www.crtonline.org, www.medscape.com,

www.theheart.org, and www.tctmd.com

WebMD

Web of Science

• Provided for an expensive fee by Thompson-Institute for

Scientific Indexing, is the basis for the computation of

impact factors and citation indexes

• Contains titles and abstracts from several thousands

journals

• In addition, it enables forward and backward snowballing

• However, it lacks the comprehensiveness of EMBASE or

PubMed

Web of Science

Questions?

Take home messages

The most important tips to remember

when looking for scientific literature are:

Take home messages



1 – begin with a broad search: it you find too much,

you can always refine the search later on

Take home messages



1 – begin with a broad search: it you find too much,

you can always refine the search later on

2 – use as starting points authoritative investigators,

seminal papers and/or clear-cut key-words

Take home messages

Introduction

What question (problem) was studied and

what is your underlying hypothesis?

Introduction

What question (problem) was studied and

what is your underlying hypothesis?

The answer is in the Introduction.

Introduction

• Catches and keeps the reader’s interest

• Uses a “funnel” type of organization

• Includes KUQE, ie Known, Unknown, the

Question, and then introduces the

Experimental approach:

– The nature and scope of the problem

– The gap or general problem

– Previous findings & pertinent literature

– The method of investigation

– The hypothesis/research question

Introduction

Expanded IMRAD algorithm

Introduction BackgroundLimitations 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

• Pose the problem in few sentences

• Review the current literature briefly and in a

crescendo manner leading to the importance and

justification of your study

• Do not state or test hypotheses other than yours

• Do estimate magnitudes

• Should usually stay in a Word page, and never

occupy more than 2 Word pages

Introduction

1. Keep problems open and undecided

2. Use the present tense for what is currently true

3. Use the past tense for previous findings

4. Use past tense to state the question

5. Avoid using names of other investigators

(unless you really want to review your paper)

6. Repeat key terms from the title

Introduction

Ways to signal the question

1. To determine whether . . .

2. The purpose of this study was . . .

3. Therefore, we tested the hypothesis . . .

4. This report describes experiments designed

to determine whether . . .

5. Therefore, our first objective in these studies

was to determine whether . . .

6. In this study, we sought to extend our

observations and to specifically test . . .

Background: nature and scope of problem

“Restenosis after an initially successful

percutaneous coronary stent

implantation remains an important

unsolved problem. Retrospective studies

have found that several clinical,

angiographic, and procedural variables

are important predictors of restenosis.1-4”

The gap

“There is considerable variation among retrospective studies, however, and the results are often difficult to interpret.2-5 Prospective trials are clearly needed to confirm the results made in retrospective studies and to assess whether the risk of restenosis can be predicted accurately in specific patients.”

Previous findings

“Several studies have reported high

rates of restenosis among patients

with insulin-dependent diabetes,6-8

as well as among those with non-

insulin-dependent diabetes.2,6-9”

The question

“Therefore, we designed a prospective trial to test whether abnormal glucose tolerance and insulin resistance increases the likelihood of restenosis. Strategies to optimize glicemic control may indeed reduce the likelihood of restenosis.”

An example

Fajadet et al, Circulation 2006

Another example

Svilaas et al, NEJM 2008

Questions?

Take home messages

Remember the KUQE approach!

Take home messages

• Known

• Unknown

• Question

• Experimental approach

Remember the KUQE approach!

Take home messages

And now a brief break…

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

metcardio.org website:

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

Clinical Writing for Interventional Cardiologists

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