Standard operating procedures: A practical approach

Abstract

Core Messages: Standard operating procedures (SOPs) offer guidance in which the diagnostic options seem to be countless. Furthermore, SOPs standardise diagnostic procedures. This is very important in key investigations when results have impact on the following treatment. Here, we present a selection of SOPs that are useful for the investigation of the underlying causes of chronic urticaria. These SOPs do not need to be adapted to specific requirements at different locations and can be used unmodified. The diagnosis of chronic urticaria is in general an unproblematic task: The presence of weals and/or angio-oedema, pruritus, and redness for more than 6 weeks will be recognised as chronic urticaria even by most untrained physicians. Far more difficult, however, is to objectively and reliably determine the urticaria subgroup the patient suffers from, and the time course and severity of the disease. The introduction of SOPs in the diagnosis of urticaria greatly improves the reliable, reproducible and observer-independent diagnosis of patients with chronic urticaria. The ICH GCP guidelines define SOP as detailed, written instructions to achieve uniformity of the performance of a specific function. It is of great importance to reach this uniformity in diagnosing urticaria subtypes and in assessing the severity of the disease, as treatment options may vary significantly depending on this information. In this chapter, we provide SOP used for the diagnosis of patients with chronic urticaria and describe the rationale for their use by hospital physicians as well as private practitioners. © 2010 Springer-Verlag Berlin Heidelberg.