2. METHODS
2.1. Data identification
For the 2023 Penile Cancer Guidelines, new and relevant evidence has been identified, collated and appraised through a structured assessment of the literature. Comprehensive literature searches were done for two major sections: epidemiology, aetiology, pathology and patient support services. Databases searched included Medline, EMBASE and the Cochrane Libraries. All search histories are available online, as are the protocols and publications of the various systematic reviews (SRs).
For the remaining sections of the text three SRs were conducted:
Review 1. What Is the Most Effective Management of the Primary Tumour in Men with Invasive Penile Cancer: A Systematic Review of the Available Treatment Options and Their Outcomes [3].
Review 2.Management of lymph node-positive penile cancer: a systematic review (in peer review).
Review 3.Systematic review and meta-analysis of minimally-invasive procedures for inguinal nodal staging in penile carcinoma: DSNB and VEIL (manuscript in preparation).
For each recommendation within the guidelines there is an accompanying online strength rating form which includes the assessment of the benefit to harms ratio and patients’ preferences for each recommendation. The strength rating forms draws on the guiding principles of the GRADE methodology but do not purport to be GRADE [4,5]. Each strength rating form addresses a number of key elements namely:
- the overall quality of the evidence which exists for the recommendation, references used in this text are graded according to a classification system modified from the Oxford Centre for Evidence-Based Medicine Levels of Evidence [6];
- the magnitude of the effect (individual or combined effects);
- the certainty of the results (precision, consistency, heterogeneity and other statistical or study related factors);
- the balance between desirable and undesirable outcomes;
- the impact of patient values and preferences on the intervention;
- the certainty of those patient values and preferences.
These key elements are the basis which panels use to define the strength rating of each recommendation. The strength of each recommendation is represented by the words ‘strong’ or ‘weak’ [7]. The strength of each recommendation is determined by the balance between desirable and undesirable consequences of alternative management strategies, the quality of the evidence (including certainty of estimates), and nature and variability of patient values and preferences.
Additional information can be found in the general Methodology section of this print, and online at the EAU website; http://www.uroweb.org/guideline/. A list of associations endorsing the EAU Guidelines can also be viewed online at the above address.
2.2. Review and future goals
This document was subject to independent peer review prior to publication. Publications ensuing from published SRs have all been peer reviewed. The results of ongoing SRs will be included in the 2024 update of the ASCO-EAU Penile Cancer Guidelines. One such review is currently ongoing: Systematic review and meta-analysis of minimally-invasive procedures for inguinal nodal staging in penile carcinoma: DSNB and VEIL.