International standards for health economic evaluation with a focus on the German approach.

WHAT IS KNOWN AND OBJECTIVE: Health economic evaluation (HEE) is increasingly used in healthcare decision-making on the allocation of limited resources in national healthcare systems. Although the methods used for HEE vary in different countries, all economic evaluations address two questions: Are limited resources used optimally? Is value for money achieved in their use? Our objective is to explain some fundamental concepts in HEE and how these concepts are adapted in different countries, notably in Germany. METHODS: We performed a bibliographic search to identify existing methods of health economic evaluation of new drugs used by the official agencies of 11 countries (Austria, Australia, Canada, Finland, France, the Netherlands, Norway, New Zealand, Sweden, the United States and England and Wales) and compared them with that used by the German national agency IQWiG. RESULTS AND DISCUSSION: All countries considered follow internationally established standards of HEE. The majority of countries, including Germany, utilize primary outcome parameters such as disease-related morbidity and mortality for assessing relative efficacy and effectiveness. The most frequently recommended form of health economic evaluation is the cost-utility analysis (CUA). The German IQWIG is the only HTA body to use the cost-benefit concept of 'efficiency frontier' in its assessment. WHAT IS NEW AND CONCLUSION: While the core principles of HEE are the same worldwide, there is a lack of harmonization in the details. This requires resource-consuming adaptations in the analyses to meet different national requirements. We describe the core principles of HEE as a common basis for further discussions by all stakeholders.

The Faces Symbol Test, a newly developed screening instrument to assess cognitive decline related to multiple sclerosis: first results of the Berlin Multi-Centre FST Validation Study.

Reliable, language-independent, short screening instruments to test for cognitive function in patients with multiple sclerosis (MS) remain rare, despite the high number of patients affected by cognitive decline. We developed a new, short screening instrument, the Faces Symbol Test (FST), and compared its diagnostic test characteristics with a composite of the Digit Symbol Substitution Test (DSST) and the Paced Auditory Serial Addition Test (PASAT), in 108 MS patients and 33 healthy controls. An Informant-Report Questionnaire, a Self-Report Questionnaire, and a neurologist's estimation of the Every Day Life Cognitive Status were also applied to the MS patients. The statistical analyses comprised of a receiver operating characteristic analysis for test accuracy and for confounding variables. The PASAT and DSST composite score estimated that 36.5% of the MS patients had cognitive impairment. The FST estimated that 40.7% of the MS patients were cognitively impaired (sensitivity 84%; specificity 85%). The FST, DSST and PASAT results were significantly correlated with the patients' physical impairment, as measured by the Expanded Disability Status Scale (EDSS). The results suggest that the FST might be a culture-free, sensitive, and practical short screening instrument for the detection of cognitive decline in patients with MS, including those in the early stages.

Routine molecular genotyping of HLA-B27 in spondyloarthropathies overcomes the obstacles of serological typing and reveals an increased B *2702 frequency in ankylosing spondylitis.

OBJECTIVE: To evaluate the reproducibility and reliability of polymerase chain reaction (PCR) in HLA-B27 typing compared to the conventionally used microlymphocytotoxicity test (MLCT). To determine the HLA-B27 subtype frequencies (B*2701-B*2709) in patients with HLA-B27 associated disease and healthy persons using sequence specific oligonucleotides (SSO). METHODS: 398 consecutive patients were HLA-B27 typed by MLCT and PCR. Subtyping by SSO was performed in 142 patients with HLA-B27 associated disease [ankylosing spondylitis (AS) n = 38, reactive arthritis 44, undifferentiated spondyloarthropathy (uSpA) 45, psoriatic arthritis 15] and 125 healthy HLA-B27 controls. RESULTS: MLCT identified 61 HLA-B27 positive patients (15.3%); PCR identified 78 positive patients (19.6%). MLCT gave false negative results for 8 patients (2.0%) and false positives for a further 7 (1.8%). Only subtypes B*2702 and B*2705 were present in patients and controls. Overall frequencies of B*2702 in patients and controls were 14.1 and 9.6%, respectively. The B*2702 frequency was significantly (pcorr. < 0.04) higher in AS (23.7%) and lower in uSpA (6.7%) patients. CONCLUSION: HLA-B27 typing by PCR is reliable and reproducible and therefore recommended for routine typing. It overcomes the obstacles of serological typing, i.e., equivocal results and cross-reactivity. In addition, subtype frequencies (B*2702 and B*2705) are equally distributed among patients and controls, although subtype B*2702 seems to be more frequent in AS and less so in uSpA.