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Wolff, Birgit (2004): Identifying the concepts contained in outcome measures of clinical trials on four internal disorders using the international classification of functioning, disability and health as a reference. Dissertation, LMU München: Medizinische Fakultät



Objectives: To systematically identify and compare the concepts contained in outcome measures of clinical trials on chronic ischemic heart disease, diabetes mellitus, obesity and obstructive pulmonary disease, including asthma using the International Classification of Functioning, Disability and Health (ICF) as a reference. Methods: Randomized controlled trials between 1993 and 2003 were located in MEDLINE and selected according predefined criteria. The outcome measures were extracted and the concepts contained in the outcome measures were linked by so called “linking rules” to the ICF. Results: 166 trials on chronic ischemic heart disease, 227 trials on diabetes mellitus, 428 trials on obesity and 253 trials on obstructive pulmonary disease were included. 10 different health status questionnaires were extracted in chronic ischemic heart disease, 19 in diabetes mellitus, 47 in obesity, 39 in obstructive pulmonary disease. Across conditions at least 75% (range: 75-92%) of the extracted concepts could be linked to the ICF. In diabetes mellitus and obesity the most used ICF- categories were ‘general metabolic functions’ (b540), in obstructive pulmonary disease ‘respiratory functions’ (b440) and in chronic ischemic heart disease ‘heart functions’ (b410). Conclusions: In all four health conditions the majority of studies were drug trials focusing on clinically relevant parameters and not on functioning. The ICF provides a useful reference to identify and quantify the concepts contained in outcome measures used in clinical trials.