Methods of the European guidelines for breast cancer screening and diagnosis
The European guidelines for breast cancer screening and diagnosis (in short, European Breast Guidelines) are being developed applying GRADE (Grading of Recommendations Assessment, Development and Evaluation) and in particular using GRADEpro Guideline Development Tool (GRADEpro GDT).
The European Commission Initiative on Breast Cancer (ECIBC) mandates the Guidelines Developing working Group (GDG) to formulate the recommendations of the European Breast Guidelines. Members of this group are transparently selected via a public call and participate on a voluntary basis.
Potential conflict of interest are managed to reduce the risk of bias and ensure adherence to the trustworthy guidelines requirements. To guarantee transparent accountability all along the development process, GDG members annually update their declarations of interests (available online) and declare specific-to-meeting interests upon meetings' agendas. On the basis of the assessment of the potential conflict of interests, members’ participation may be limited according to the established procedure.
Step 1. Prioritisation of the European Breast Guidelines questions
The GDG compiles an extensive list of potential questions on breast cancer screening and care, such as “What age range should undergo breast cancer screening?”, and submits it for public consultation. Based on the results of the consultation the GDG finalises a list of questions to be rated for relevance and prioritised accordingly.
Step 2. Framing the questions
The GDG formulates the questions of the European Breast Guidelines according to a widely used structured format, generally called “PICO”, which stands for Population under study (for example women of certain age); Intervention (for example a medical examination); Comparator (other main options such as an alternative medical examination); and Outcomes (results).
The GDG defines the PICO elements of each question (the who and the what, for example, women of a certain age to attend or not-attend a specific medical examination) and, selects only the “Outcomes” (results) defined as ‘critical’ or ‘important’ for decision making.
Step 3. Quality of the evidence related to each question
The evidence is searched using already existing systematic reviews or conducting new ones. In this phase both, the evidence related to all patients’ outcomes, and the actual value patients put on them, are taken into consideration.
The GDG applies a two-step process for rating the quality of the evidence:
- firstly, it rates the quality of evidence for each outcome (it can vary across outcomes), and
- then, it rates the quality of evidence for each recommendation across all outcomes.
The overall quality of evidence for a recommendation results from these combined ratings. It is then discussed and agreed within the GDG.
The European Commission outsources systematic reviews, evidence profiles, and draft recommendations to a multidisciplinary group of methodologists, information specialists, health economists, and qualitative researchers, based at the Iberoamerican Cochrane Centre (GRADE center, Barcelona, Spain).
Step 4. Going from the evidence to the recommendation
The Iberoamerican Cochrane Centre supplies Evidence-to-Decision frameworks (EtDs) which provide a systematic and transparent approach for going from the evidence to the healthcare decision.
GDG members use EtDs to vote or to achieve consensus on each recommendation, in favour or against an option. EtDs include criteria, such as the quality of the evidence, or the values and preferences of patients, which permit to formulate recommendations as “strong” or “weak/conditional” depending on the respective weight of desirable and undesirable effects.