Methods for Development of the European Commission Initiative on Breast Cancer Guidelines: Recommendations in the Era of Guideline Transparency.

Schünemann HJ1, Lerda D2, Dimitrova N2, Alonso-Coello P3, Gräwingholt A4, Quinn C5, Follmann M6, Mansel R7, Sardanelli F8, Rossi PG9, Lebeau A10, Nyström L11, Broeders M12, Ioannidou-Mouzaka L13, Duffy SW14, Borisch B15, Fitzpatrick P16, Hofvind S17, Castells X18, Giordano L19, Warman S20, Saz-Parkinson Z2; European Commission Initiative on Breast Cancer Contributor Group.

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Abstract

Neither breast cancer prevention and early-detection programs, nor their outcomes, are uniform across Europe. This article describes the rationale, methods, and process for development of the European Commission (EC) Initiative on Breast Cancer Screening and Diagnosis Guidelines. To be consistent with standards set by the Institute of Medicine and others, the EC followed 6 general principles. First, the EC selected, via an open call, a panel with broad representation of areas of expertise. Second, it ensured that all recommendations were supported by systematic reviews. Third, the EC separately considered important subgroups of women, included patient advocates in the guidelines development group, and focused on good communication to inform women's decisions. Fourth, EC rules on conflicts of interest were followed and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests. Fifth, it focused its recommendations on outcomes that matter to women, and certainty of the evidence is rated for each. Sixth, the EC elicited stakeholder feedback to ensure that the recommendations remain up to date and relevant to practice. This article describes the approach and highlights ways of disseminating and adapting the recommendations both within and outside Europe, using innovative information technology tools.