LAUSR

TO THE EDITOR: I read Schünemann and colleagues' article (1) with interest. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) working group has invented concepts and defined methods to develop practice guidelines. The GRADE system tends to become the gold standard worldwide, and with good reason. For example, this framework has been endorsed by the European Commission to develop their breast cancer guidelines (1). These guidelines state, “for asymptomatic women aged 50 to 69 with an average risk of breast cancer, mammography screening is recommended in the context of an organised screening programme (strong recommendation, moderate certainty in the evidence)” (2). The authors of this recommendation also report “possibly important uncertainty about or variability in how much people value the main outcomes” (2). In real life, this uncertainty or variability is shown by the fact that participation rates among women who are invited to take part in organized screening programs rarely—and barely—exceed 70%. One excellent aspect of the GRADE framework is that recommendations can be strong or conditional. Guideline panels following this framework will make strong recommendations when the benefits of an intervention clearly outweigh the harms and burdens; therefore, all or almost all fully informed patients can make the same choice. Panels make discretionary recommendations when the benefits and harms are more closely balanced. Most patients would choose the recommended course of action, but a few would not. The 30% or more of these potential participants who decline screening because how much they value the outcome varies or is uncertain deserve recommendations that—if the GRADE system actually had been used—should have been conditional and not strong. Lack of applicability is a major problem with guidelines. How can the European Commission and GRADE expect their guidelines to be applicable and trustworthy if their recommendations do not adhere to their own systems?