Clinical research original article: How to write an article and get it published

in European UrologyShahrokh F. Shariat, MD

Chair and Professor, Medical University of Vienna, Vienna, AUT

Adjunct Professor, Weill Cornell Medical University and New York Presbyterian Hospital, New York, USA

Adjunct Professor of Urology, UT Southwestern, Dallas, Texas, USA

Remember the

purpose of your

manuscript

…is to inform

Introduction

Materials & Methods

Results

Discussion

Conclusions

Introduction

Materials & Methods

Results

Discussion

Conclusions

A single piece of work

• Keep it joined together• One section should flow

into the next

• NO SURPRISES

• Clearly and simply explain – what the research question is– why it is relevant, why it is original– very briefly how it will be answered

Introduction section

• Summarize other relevant papers in orderly

fashion (logic) to set the background– Not be an in-depth literature review

Introduction section

• An excellent study has an obviously important and

original question, and therefore needs only brief

introduction.

– Make it short: 250-500 words,

~3-4 paragraphs,

1 page

Introduction section

• 1st paragraph: brief background in present tense to establish context, relevance, or nature of the problem, question, or purpose (what we know)

• 2nd paragraph: importance of the problem and unclear issues (what we do not know - gap in knowledge - why it is important to fill that gap)

• 3rd paragraph: rationale, hypothesis, main objective, or purpose (why the study was done - hypothesis for how you will fill that gap in knowledge).

Introduction section

Introduction section

1st paragraph:

brief background on

radical cystectomy and

role of lymph node

dissection

Introduction section2nd paragraph: importance of the problem and unclear issues (minimal number of LN to remove, anatomical extent of LND, role of pT stage as predictor of LN involvement)

3rd paragraph: rationale, hypothesis, main objective

• Usually not easy for inexperienced authors

• Writing intro last can prevent writer’s block and is

easier

Introduction section

• M&M section is the core of each paper• Describes - study design,

- how it was performed, and

- data analysis• Provides all elements to allow others to reproduce the study• Easiest part of manuscript• Writing this section of the paper in the most complete way

before starting the study can help to discover methodological biases in a moment when they are easily fixed!

Methods section

• Period of enrolment/evaluation• Type of study (retrospective; prospective; controlled;

randomized)• Inclusion criteria / patient selection• Exclusion criteria / reasons to exclude patients• Details on used materials or technique - report in detail original methods/techniques

- cite (and reference) known methods• Ethical issues

What methods section should include

http://www.equator-network.org/home/

http://www.equator-network.org/home/

http://www.equator-network.org/home/

Methods section in RCT – CONSORT statement

www.consort-statement.org

Methods section

IRB approval

Quality control

Inclusion/exclusion criteria

Description of pathology procedure

Clinical setting

TNM staging system

• Study results

- by definition, they go in the “Results” section

• Comments

- on patients characteristics, indications, inclusion and

exclusion criteria they go in the “Discussion” section

What methods section should NOT include

Results• Describe final population

• Patient details

• Describe intervention

• Treatments

• Observations

• Describe outcomes

• Survival

• Disease related

• Toxicities

• Others

Discussion• Summarize your main findings

• Compare your data with previous reports

• Describe & explain discrepancies

• Where do your findings sit in our world

• Where are they going to take us

• What next ….

• Limitations and concerns

• Final conclusions

The discussion should place your findings into the scientific literature

Results: General design

• Patient population(s)• Treatment(s) received

• Outcomes in each group• Good and Bad findings

• Comparisons between groups• Analysis of each factor/predictive features

Results – Using figures and tables

Text

Tables

Figures

Text

Tables Figures

They should integrate together

Need all three components

to understand the paper

But … a reader should be

able to follow paper using

just tables and figures

So … make the legends

descriptive and include all

necessary findings

Results – Using figures and tables

Results

• Be clear about your study ….. what is it? Observational Retrospective or prospective Single or Multi-institutional Data quality Screening Randomized or other

• Whilst Result organization is broadly similar ... each may require different reporting details

Results

CONSORT Guidelines = A good place to start- Participant flow

Initial participants

Final participantsTypically Table 1. = Details of participants

Figure 1. = Flow chart- What time period?

Consecutive or selected patientsFiltered cases or “all comers”

- Institutions –How many from each?

http://www.consort-statement.org/

Why excluded?

Table 1. Details of patients and treatments

The purpose of this table is to allow a reader to use your data:Clinicians:1. Do the cases represent the disease?2. Are the patients the same as mine?3. Can I identify how to treat a patient in clinic?Researchers:4. Can I use your data to compare with my results 5. Can I incorporate these into a meta-analysis6. Can I use these data for new research?Patients:7. Have I been treated correctly?8. Is there a better doctor for me?

How to report data?

Continuous datae.g. Age, PSA ….Show range, distribution and variability

Mean and standard deviation, if normally distributedMedian and ranges (25th and 75th centiles), if not

Ordinal or nominal datae.g. stage or gradeTreat as individuals (not as continuous data)Shown number and proportions for each

Compare populations, if relevantAre the patients or the disease the same in each arm?

Figure 1. Flow chart of patients/studies/interventions

Keep it as simple as possible

Results: Outcomes - reporting and analysis

In general:

- The results should match the primary and

secondary outcomes (as stated in M&M)

- Use paragraphs/sections for each outcome

- Intention to treat analysis is more robust (as it

avoids bias of losses or excluded cases)

Methods

Results

Methods

Results

Results: Outcomes - reporting and analysis

• Report outcomes for each

arm/population

• Table 2. typically report appropriate

details (mean/median & St. Dev or

Ranges)

• Use confidence intervals (95% CI)

Results – Survival outcomes

Be precise ….

1. Are you describing death or survival

Disease specific survival vs. Disease specific mortality

2. What are you describing?

Overall survival (death all causes) vs. Non-disease

specific survival (death from other causes) or competing

mortality vs. disease specific survival

Results – Treatment outcomes

Be precise …. in your terminology1. Bladder cancer behavior

Recurrence, Progression, Relapse ….2. Prostate cancer treatment

PSA recurrence – Post surgery, Post ADT, Post radiotherapy

3. Incontinence outcomes Pads, further treatment, QOL outcomes

4. etc.

Results – Treatment outcomes

Be precise ….

Use Objective measures where possible

use of another treatment (salvage radiotherapy)

worsening radiology or pathology

Try to avoid clinician based outcomes “progression” or

“failure” with no supporting data

Use blinded outcomes where possible

Results – Treatment outcomes

Be precise …. Use Important outcomes (to the patient, clinician,

researcher, society, healthcare provider … )

Results – Treatment outcomes

Be precise …. Use Realistic outcomes

Results – Compare outcomes: Specifics

Use the appropriate test

For the Data:

Distribution: Normal or not

Data: Continuous or interval outcomes

Binary or many intervals

Nominal data

Beware of too few cases

Results – Compare outcomes: Specifics

Use the appropriate test

For the Outcome:

Inter group comparisons

Relative and absolute outcomes

Survival analysis

Competing mortality

Numbers needed to treat

Adjustments for trial design

Results – Compare outcomes: Specifics

Use the appropriate test For the Context:

Univarbiable vs. MultivariablePrognostic vs. Predictive

Results – Compare outcomes: General concepts

Results – Compare outcomes: General concepts

Statistical vs. clinical significance

Results: Further analysis

Typical to look at sub-group analysis or analysis of variables in later sectionsMaybe the most interesting findingsAgain … be realistic with your dataPresent analyses clearly and logicallyDo not look for analysis where the data are missing Do not perform analysis that are not justifiedKeep the reader with you

Discussion

• Briefly summarize your findings• Answer your initial question

• Briefly mention previous reports and compare your data these reports• Explain differences – you may both be right!

• Place your findings into the field• How important are they?• How strong can your conclusions be?• How does this change patient care/treatments etc.?• Where next with this field/work ….

• Limitations and shortcomings: Be critical and open with limitations … it makes the data more believable and the paper stronger

Discussion: Common issues and faults

• Too long • Too many points addressed

• Too many comparisons and in too much detail• Incoherent or illogical organization

• Poor flow, changing directions, back and forth ….

• Write on paper a plan and stick to it

• Discussion that is not supported by the data• Not addressing major inconstancies with the field

• Too limited discussion of weaknesses etc.

The final check1. Do you clearly state/explain and answer your main question?2. Have you explained the novelty and importance of this work? Is it

clear for someone outside the field?3. Rigor and presentation:

We are trusting that you have done this work/reported the outcomesIf you can not be bothered to present/edit/check the paper properly …. then have you really treated 2,500 men consistently ?

4. Consistency: Abstract vs. main bodyTables & figures vs. main text

5. Are your conclusions justified?