Clinical research original article: How to write the introduction and methods

sections

Giacomo Novara, M.D., F.E.B.U.Department of oncological and surgical sciences

Urology Clinic - University of Padua, Padua, Italy

Associate editor of European Urology

giacomonovara@gmail.com

HOW TO WRITE A MANUSCRIPT AND GET IT PUBLISHED IN EUROPEAN UROLOGY

• 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

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 very easy to write for inexperienced

authors

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

easier

Introduction section

• Material and methods section is the core of each

paper

• It describes how the study was designed, and

performed as well as the way the data were

analyzed

• It has to provide all the elements to allow other

authors to reproduce the study

Methods section

• It is the easiest part of the manuscript to write

• 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

What methods section should include

• 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 – Consolidated Standards of Reporting Trials (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

Statistical analysis

• Reference only the test which are not well known

• Report the p value for statistical significance

(p<0.05 - probability of a false positive result)

• Provide an estimation of the study power (beta

error – probability of a false negative result)

• Specify the used software

Statistical analysis

• Very complex statistical tests are seldom useful

• Whenever used, they should be explained and

referenced

• Fancy statistics are meaningless if not strictly

related with the clinical problem

Methods section

Reference for the complex statistical methods

Explanations

Assumptions