Methods Christian Gratzke LMU Munich Department of Urology

Methods Christian Gratzke LMU Munich Department of Urology London, March 2017 KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

Material & 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 KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

Material & 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! KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

Material & Methods • Period of enrolment/evaluation • Type of study (retrospective; prospective; controlled; randomized) • Inclusion criteria / patient selection • Exclusion criteria / reasons to exclude patients KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

Material & Methods • Details on used materials or technique - report in detail original methods/techniques - cite (and reference) known methods • Ethical issue KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

IRB approval Clinical setting Quality control Inclusion criteria Exclusion criteria Detail on centers involved (added on reviewer’s request) KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

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 KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

Material & Methods Description of followup protocols Definition of the events (disease recurrence and death of disease) KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

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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 KLINIKUM DER UNIVERSITÄT MÜNCHEN ® http: //www. equator-network. org/home/ UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

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Material & Methods section in RCT – Consolidated Standards of Reporting Trials (Consort) KLINIKUM DER UNIVERSITÄT MÜNCHEN ® www. consort-statement. org UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

Material & Methods – basic research Describe what you did – lab note book recordings! Antibody specifications, concentrations, dosages: the reader needs to be able to reproduce the method If the technique is well-established, it may be referenced Short passages for each technique employed KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

Material & Methods – basic research Try to keep it simple, even if it is a sophisticated topic Descriptions should be crisp and accurate (word count!) Statistics need to be clearly defined Don´t forget to mention the ethical permission If the methods section is unclear, the ms will fail! KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

What Methods 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) KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN

Thank you KLINIKUM DER UNIVERSITÄT MÜNCHEN ® UROLOGISCHE KLINIK UND POLIKLINIK CAMPUS GROSSHADERN