1. Clinica urologica, università di Padova
Materiali e metodi
Giacomo Novara
Clinica urologica, università di Padova 1

2. Materials and methods
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

3. Materials and methods
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!

4. Materials and methods Period of enrolment/evaluation
Type of study (retrospective; prospective;
controlled; randomized)
Inclusion criteria / patient selection
Exclusion criteria / reasons to exclude patients

5. Materials and methods Details on used materials or technique
- report in detail original methods/techniques
- cite (and reference) known methods
Ethical issue

6. IRB approval
Clinical setting
Quality control
Inclusion criteria
Exclusion criteria
Detail on centers
involved
(added on reviewer’s
request)

7. Description of surgery of the primary
tumor and lymph node
Description of pathology procedure
TNM staging system and grading system
Describe in detail what is of central
relevance or not standardized or not
well known

8. Materials and methods Description of follow-up protocols
Definition of the events (disease
recurrence and death of disease)

10. Equator network
International initiative seeking to enhance reliability and value of medical research literature by promoting transparent and accurate reporting of research studies
Raising awareness of the crucial importance of good reporting of research
Becoming the recognised global centre providing resources, education and training relating to the reporting of health research and use of reporting guidelines

14. Methods section in RCT – Consolidated Standards of Reporting Trials (CONSORT) statement

15. 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)

16. Statistical analysis
Should cite the tests which have been used in the different circumstances
The choice of the statistic test depends on the nature of the variables
categorical variables
continuous variables (parametric; non parametric)

17. Methods section and statistical analysis
The continuous variables are
not all the same!
One of the most common
mistakes in the papers submitted
to Eur Urol I reviewed in the
last years

18. Follow-up duration (slide from Prof. Studer)6 4 2 1 15
≤ 1 year: 18/20 (90%) 14
years
median 0.5 year (IQR , range )
mean 2 years (SD ± 4.5, SEM ± 1)

19. Statistical analysis Reference only the test which are not well known
Report the p value for statistical significance
(p< 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

20. Methods section and statistical analysis
Comparisons of categorical
and continuous variables
Survival function, univariable
and multivariable analyses
Detail on an uncommon
statistical issue (interaction
terms in multivariable models)
P values and software

21. 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
What might be hard for an experience reviewer will be impossible to understand for most of the readers

22. Who should run the statistics?
An experienced biostatistician is the best option, whenever available (although he might struggle to focus on the clinical problem)
Being urologist, I usually do 99% of my statistics by myself (no risk of misunderstanding the clinical problem, minimal risk of doing wrong things on routinary statistics)

23. …