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

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

Introduction section • 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 section 2nd 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

Introduction section • Usually not very easy to write for inexperienced authors • Writing intro last can prevent writer’s block and is easier

Methods 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!

What methods section should include • 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

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 Clinical setting Inclusion/exclusion criteria Description of pathology procedure TNM staging system

What methods section should NOT include • 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)

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

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