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