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Drug hypersensitivity reactions are unpredictable adverse drug reactions. They manifest either within 1–6 h following drug intake (immediate reactions) with mild to life-threatening symptoms of anaphylaxis, or several hours to days later (delayed reactions), primarily as exanthematous eruptions. It is not always possible to detect involvement of the immune system (allergy). Waiving diagnostic tests can result in severe reactions on renewed exposure on the one hand, and to unjustified treatment restrictions on the other. With this guideline, experts from various specialist societies and institutions have formulated recommendations and an algorithm for the diagnosis of allergies. The key principles of diagnosing allergic/hypersensitivity drug reactions are presented. Where possible, the objective is to perform allergy diagnostics within 4 weeks–6 months following the reaction. A clinical classification of symptoms based on the morphology and time course of the reaction is required in order to plan a diagnostic work-up. In the case of typical symptoms of a drug hypersensitivity reaction and unequivocal findings from validated skin and/or laboratory tests, a reaction can be attributed to a trigger with sufficient confidence. However, skin and laboratory tests are often negative or insufficiently reliable. In such cases, controlled provocation testing is required to clarify drug reactions. This method is reliable and safe when attention is paid to indications and contraindications and performed under appropriate medical supervision. The results of the overall assessment are discussed with the patient and documented in an „allergy passport“ in order to ensure targeted avoidance in the future and allow the use of alternative drugs where possible.

General design: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group).¶Objective: The trial design includes the following elements for a prototype protocol:¶ - The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4).¶ - Patients are allocated by random to the control or treatment group.¶ - The double blinding strategy of the trial is assessed by psychometric indices.¶ - An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors.¶ - Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales.¶Conclusion: This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.¶

In einer Beobachtungsstudie wurden 178 ambulante Patienten mit Verletzungen an der unteren Extremitat, die nach Abwagung ihres individuellen Thromboserisikos anhand einer Checkliste keine medikamentose Thromboembolieprophylaxe erhielten; auf das Auftreten von tiefen Beinvenenthrombosen getestet. Nach Abnahme des Gipsverbands nach durchschnittlich 14,4 (Range 5–48) Tagen erfolgte eine klinische und farbkodierte duplexsonographische Untersuchung. Bei positiven Ausfall einer oder beider Untersuchungen wurde eine Phlebographie durchgefuhrt. Von den 178 untersuchten Studienpatienten entwickelten 2 Patienten eine isolierte Einbundelunterschenkelvenenthrombose (Thromboseinzidenz 1,1%, 95-%-Konfidenzintervall 0–4,4%). Eine Lungenembolie wurde bei keinem Patienten beobachtet. Aufgrund unserer Ergebnisse erscheint eine generelle medikamentose Thromboembolieprophylaxe bei jungen, gesunden Patienten mit einer Verletzung an der unteren Extremitat und einer Ruhigstellung im Gipsverband nicht indiziert.

Methods We performed a systematic literature analysis in PubMed (deadline: 15 January 2010, terms “juvenile idiopathic (rheumatoid) arthritis”, “therapy”, limits: “humans”, “published in the last 3 years”, “all child 018 years”, “clinical trial”) and evaluated relevant studies for quality of methodology. A formal consensus process, i.e. Nominal group technique and Delphi method, was conducted at three moderated consensus conferences at Dusseldorf or Krefeld (Germany) on May 9, 2007, August 1, 2007 and January 15, 2010. Conferences were attended by 95% of the representatives who had been nominated by their scientific society or organizations.