2. METHODS
2.1. Introduction
These Guidelines were compiled based on current literature following a structured review. Databases covered by the searches included Pubmed, Ovid, EMBASE and the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews. Application of a structured analysis of the literature was not possible in many conditions due to a lack of well-designed studies. The limited availability of large randomised controlled trials (RCTs) - influenced also by the fact that a considerable number of treatment options relate to surgical interventions on a large spectrum of different congenital problems - means this document is largely a consensus document. Clearly there is a need for continuous re-evaluation of the information presented in this document.
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 form draws on the guiding principles of the GRADE methodology but do not purport to be GRADE [9,10]. Each strength rating form addresses a number of key elements namely:
1. 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 [11];
2. the magnitude of the effect (individual or combined effects);
3. the certainty of the results (precision, consistency, heterogeneity and other statistical or study related factors);
4. the balance between desirable and undesirable outcomes;
5. the impact of patient values and preferences on the intervention;
6. 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’ [12]. 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. The strength rating forms are available online.
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. Peer review
All chapters of the Paediatric Urology Guidelines were peer-reviewed in 2015.