[PET and diagnostic technology evaluation in a global clinical process. DGN's point of view].
The German Society of Nuclear Medicine (DGN) criticizes the methodological approach of the IQWiG for evaluation of PET and the conclusions, which represent the opposite point of view compared to the most other European countries and health companies in the USA: 1.) Real integration of experienced physicians into the interpretation of data and the evaluation of effectiveness should be used for best possible reporting instead of only formal hearing. 2.) Data of the National Oncologic PET Registry (NOPR) from the USA have shown, that PET has changed the therapeutic management in 38% of patients. 3.) The decision of the IQWiG to accept outcome data only for their benefit analyses, is controversial. Medical knowledge is generated by different methods, and an actual analysis of the scientific guidelines has shown that only 15 % out of all guidelines are based on the level of evidence demanded by the IQWiG. Health economics has created different assessment methods for the evaluation of a diagnostic procedure. The strategy chosen by the IQWiG overestimated the perspective of the population and undervalue the benefit for an individual patient. 4.) PET evaluates the effectiveness of a therapeutic procedure, but does not create an effective therapy. When the predictive value of PET is already implemented in a specific study design and the result of PET define a specific management, the trial evaluate the whole algorithm and PET is part of this algorithm only. When PET is implemented as test during chemotherapy or by the end of chemotherapy, the predictive value of PET will depend decisively on the effectiveness of the therapy: The better the therapy, the smaller the differences in survival detected by PET. 5.) The significance of an optimal staging by the integration of PET will increase. Rationale is the actual development of "titration" of chemotherapy intensity and radiation dose towards the lowest possible, just about effective dosage. 6.) The medical therapy of malignancies will be improved continuously. It is the claim of the health insurances to implement innovative therapeutic approaches in controlled clinical trials with tools of quality control. The monitoring committee is responsible for the safety of the patients. PET is part of the health care. Internationally accepted rules for clinical trials stipulate that any interim analyses of those trials are confidential as long as recruitment is active. The delay until evidence is documented by the published final analysis is methodologically accepted and not a characteristic of PET. 7.) Procedures in nuclear medicine without the use of PET-tracers with short half-life will increase the radiation exposure of the patients; the use of non-PET-tracers with longer half-life is in contravention of the German regulation of radiation protection.
Kotzerke
J
J
Klinik und Poliklinik für Nuklearmedizin der Universitätsklinikum Dresden, Fetscherstr. 74, 01307 Dresden, Germany. joerg.kotzerke@mailbox.tu-dresden.de
Dietlein
M
M
Grünwald
F
F
Bockisch
A
A
D005858:Germany; D006207:Half-Life; D006801:Humans; D009683:Nuclear Medicine / Q000379:methods / Q000592:standards*; D049268:Positron-Emission Tomography / Q000379:methods / Q000592:standards*; D011835:Radiation Protection / Q000592:standards; D011868:Radioisotopes / Q000009:adverse effects; D012955:Societies, Medical
D011868:Radioisotopes