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.

OBJECTIVES: To systematically identify and compare the concepts contained in outcome measures of clinical trials on chronic ischaemic 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 to the ICF. RESULTS: 166 trials on chronic ischaemic heart disease, 227 trials on diabetes mellitus, 428 trials on obesity, and 253 trials on obstructive pulmonary disease were included. Ten different health status questionnaires (fulfilling the inclusion criteria) were extracted in chronic ischaemic heart disease, 19 in diabetes mellitus, 47 in obesity, and 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 respiration functions (b440) and in chronic ischaemic heart disease heart functions (b410). CONCLUSION: In all 4 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 assessment used in clinical trials.

ICF Core Sets for diabetes mellitus.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set and a Brief ICF Core Set for diabetes mellitus. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review, and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 253 ICF categories at the second, third, and fourth ICF levels with 99 categories on body functions, 40 on body structures, 55 on activities and participation, and 59 on environmental factors. Fifteen experts attended the consensus conference on diabetes mellitus (8 physicians with various sub-specializations; 5 physical therapists, one epidemiologist and one social worker). Altogether 99 categories (85 second-level and 14 third-level categories) were included in the Comprehensive ICF Core Set with 36 categories from the component body functions, 16 from body structures, 18 from activities and participation, and 29 from environmental factors. The Brief ICF Core Set included a total of 33 second-level categories with 12 on body functions, 6 on body structures, 5 on activities and participation, and 10 on environmental factors. CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for diabetes mellitus. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.